JULY 2009

WEEK ENDING JULY 25

Nutracoastal Trading LLC conducts nationwide recall of STEAM Dietary supplement lot 80214 

Nutracoastal Trading LLC is recalling the company's dietary supplement product sold under the following name: STEAM.

Lab analysis for Lot 80214 found that the product contains sulfoaildenafil, an analog of sildenafil.  Sildenafil is an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making STEAM DIETARY SUPPLEMENT an unapproved drug.  

The recalled product listed below was distributed in white plastic bottles to retail stores nationwide.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Consumers should return any unused product to the retail location where they were purchased or contact Nutracoastal Trading LLC directly at 866-803-2434 Monday - Friday, 9 am to 5 pm EDT.

Nutracoastal Trading LLC conducts nationwide recall of S-DROL Dietary supplement lot 810481 

Nutracoastal Trading LLC is recalling the company's dietary supplement product sold under the following name: S-DROL.

Lab analysis for Lot 810481 found that the product contains desoxymethyltestosterone, a steroid, making S-DROL DIETARY SUPPLEMENT an unapproved drug. 

The recalled product listed below was distributed in black plastic bottles to retail stores nationwide.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Consumers should return any unused products to the retail location where they were purchased or contact Nutracoastal Trading LLC directly at 866-803-2434 Monday - Friday, 9 am to 5 pm EDT.

PRODUCT  LIBIMAX All Natural Herbal Extract Capsules, 430 mg herbal blend, sold in 1-capsule individual packs and 10-capsule or 20-capsule plastic bottles, Libido Enhancer, Rev Up Your Sex Drive, 
CODE All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nature & Health Company, Brea, CA, 
Manufacturer: Shenyang Green Near Health Food CO., LTD, Shenyang, China. 
REASON Unapproved New Drug; product contained undeclared active pharmaceutical ingredient tadalafil.
VOLUME OF PRODUCT IN COMMERCE
Approximately 400 cases/720 individual packets per case; 1,000 bottles of 10 capsule bottle; 300 bottles of the 20 capsule bottle
DISTRIBUTION CA, GA, IL, TX, OH

PRODUCT Zencore Plus, Natural Male Enhancement Dietary Supplement, 275mg proprietary blend of herbal ingredients, supplied in 2 capsule blister packs and 10 capsule blister packs, labeled...It's Natural And It Works, For Male Sexual Performance, UPC for 10 Capsule box: 8 5919700106 8; UPC Code for Individual 2 Capsule Packet: 8 5919700102 0; UPC Code for Display Box 8 5919700103 7. 
CODE All lot codes
RECALLING FIRM/MANUFACTURER
Hi Tech Pharmaceuticals, Norcross, GA, 
REASON Unapproved New Drug; product found to contain benzamidenafil which is a newly discovered PDE-5 inhibitor similar to FDA approved drugs to treat erectile dysfunction.
VOLUME OF PRODUCT IN COMMERCE
1,500,000 capsules
DISTRIBUTION Nationwide

PRODUCT Digoxin, 0.25 mg, packaged in 30 tablet bottles, NDC 57664-441-04, part #5758-0; Rx only. CODE Lot numbers 9023045, 8350165, 8325065, 8294169, 8291068, 8086157, 8045070, 7334139 and 7218363
RECALLING FIRM/MANUFACTURER
A-S Medication Solutions LLC, Libertyville, IL
REASON Some of the tablets are over sized or undersized, which will result in the patient not receiving the expected dose of medication.
VOLUME OF PRODUCT IN COMMERCE
670 bottles
DISTRIBUTION Nationwide

PRODUCT 
1) Amicar, Aminocaproic Acid, 500MG Tablet, Mfg. XAN, NDC 66479-0021-82, Rx Only. 

2) Methimazole, 5MG TAB, Mfg. PAR, NDC 49884-0640-01, Rx Only. ; 

3) Levothyroxine, 137MCF TAB, Mfg. MYL, NDC 00378-1823-01, Rx Only. 

4) Cerovite, sub: Centrum Liquid, 15ML, Mfg. RUG, NDC 00536-2790-59, OTC. 

5) Azilect, Rasagiline Mesylate, 1MG TAB, Mfg. TNE, NDC 68546-0229-56, Rx Only. 

6) Durahist, P-Ephedr/CPM/Methscop, 60/8/1.25MG TAB, Mfg. PEL, NDC 66869-0424-10, Rx Only. 

7) Ferrex-150 Plus, CAP, Mfg. Brk, NDC 51991-0703-90, OTC. 

8) Propylthiouracil, 50MG TAB, Mfg. W-W, NDC 00143-1480-01, Rx Only. 

9) Acetaminophen, sub: Tylenol, 325MG TAB, Mfg. IVX, NDC 00182-1000-10, OTC. 

10) Isoniazid, 100MG TAB, Mfg. BAR, NDC 00555-006-02, Rx Only. 

11) Vitamin D, Cholcalciferol, 400IU TAB, Mfg. NVC, NDC 79854-0011-62, OTC. 

12) Phillips, Magnesium Hydroxide, 311MG, Chew Tab, Mfg. BAY, NDC 31284-3373-12, OTC. 

13) Thyroid, gr, 15MG TAB, Mfg. FOR, NDC 00456-0457-01, Rx Only. 

14) Terazosin HCL, 10MG CAP, Mfg. A-C, NDC 60505-0118-00, Rx Only. 

15) Razadyne, Galantamine HBr, 8Mg TAB, Mfg. JOM, Rx Only.

16) Nephro-Vite, TAB, Mfg R&D, NDC 00536-7300-01, OTC. 

17) Docusate Calcium, 240MG CAP, Mfg. RUG, NDC 00536-3755-05, OTC. 

18) Glyburide/Metformin, sub: Glucovance, 1.25/250MG TAB, Mfg. TEV, NDC 00093-5710-01, Rx Only. 

19) Diltiazem, HCL ER, Extended-Release, 240MG CAP, Mfg. MYL, Rx Only. 

20) Gerivite, Multivits W-Fe & Min, LIQ, 15ML, Mfg. GDL, NDC 00182-6054-40, OTC. 

21) Demeclocycline, 150MG TAB, Mfg. GLO, NDC 00115-2111-01, Rx Only. 

22) Nortriptyline, sub: Pamelor, 25MG CAP, Mfg. TEV, NDC 00093-0811-01, Rx Only. 

23) Nabumetone, 750MG TABLET, Mfg. SDZ, NDC 00185-0146-01, Rx Only. ;

24) Ethosuximide, sub: Zarontin, 250MG CAP, Mfg. PLV, NDC 50111-0901-01, Rx Only. 

25) Sotalol HCl, 80MG TABLET, Mfg. A-C, NDC 60505-0090-11, Rx Only. 

26) Glybutide/Metformin sub: Glucovance, 5/500MG TAB, Mfg. TEV, NDC 00093-5712-01, Rx Only. 

27) Potassium Citrate ER, sub: Urocit-K. 5MEQ TAB, Mfg. RIS, NDC 64980-0137-01, Rx Only. 

28) Lexapro, Escitalopram, 5MG TAB, Mfg. FOR, NDC 00456-2005-01, Rx Only. 

29) Tylenol Arthritis, Acetaminophen E-R, 650MG TAB, Mfg. MCN, NDC 00045-0838-50, OTC. 

30) Omega-3, Fish Oil, 1000MG SOFGELS, Mfg. N-B, NDC 74312-0278-11, OTC. 

31) Calcitriol, 0.25MCG CAP, Mfg. TEV, NDC 00093-1657-01, Rx Only. 

32) Wellbutrin XL, Buproprion HCl ER, 150MG TAB, Mfg. BPC, NDC 00173-0730-02, Rx Only. 

33) Carbamide Peroxide, Ear Wax Removal, 6.5% Ear Drops, 15ML, Mfg. MAJ, NDC 00901-3220-35, OTC.  

34) Theophylline, Extended-Release, 300MG TAB, Mfg. PLV, NDC 50111-0459-01, Rx Only. 

35) Mirapex, Pramipexole, 0.5MG TAB, Mfg. BOE, Rx Only. 

36) Multivitamin W/MIN, ONE-TAB-DAILY W/MIN, SF TAB, Mfg. GDL, OTC.  

37) Glyburide/Metformin, 5MG/500MG TAB, Mfg. APH, NDC 00228-2753-11, Rx Only. 

38) Thermotabs, Salt Supplement, Buffered TAB, Mfg. NUM, NDC 38485-0863-35, OTC. 

39) Sotalol HCl, 240MG TABLET, Mfg. SDZ, Rx Only, 

40) Venlafaxine HCl, 37.5MG TAB, Mfg. RED, Rx Only. 

41) Simethicone, sub: GAS-X EXTRA STR, 125MG CHEW TAB, Mfg. RUG, NDC 00536-4534-08, OTC. 

42) Amlodipine/Benazepril, 10/20MG CAP, Mfg. SNZ, NDC 00781-1174-01, Rx Only. 

43) Armour Thyroid, 60MG (1 gr) TAB, Mfg. FOR, NDC 00456-0459-01, Rx Only. 

44) Neomycin Sulf, 500MG TAB, Mfg. TEV, Rx Only. 

45) Rocaltrol, Calcitriol, 0.25 MCG CAP, Mfg. FON, NDC 42559-0143-23, Rx Only. 

46) Glycerin, 82.5% Suppository, Mfg. G&W, OTC. 

47) Bromocriptine, 2.5MG TAB, Mfg. SNZ, NDC 00781-5325-31, Rx Only. 

48) Fluoxetine HCL, 10MG TAB, Mfg. PAR, NDC 49884-0734-11, Rx Only. 

49) Fluconazole, 100MG TAB, Mfg. R/P, NDC 63304-0804-01, Rx Only. 

50) Rowasa, Mesalamine, 4G/60ML Enema, 60ML, Mfg. ALA, Rx Only. 

51) Uroxatral ER, Alfuzosin ER, 10MG TAB, Mfg. AVE, NDC 00024-4200-10, Rx Only. 

52) Ultram ER, Tramadol ER, 100MG TAB, Mfg. BPC, NDC 00062-0653-30, Rx Only. 

53) Docusate Calcuim, 240MG, CAP, Mfg. GDL, NDC 0018-1302-05, OTC. 

54) Sensipar, Cinacalcet, 60MG TABLET, Mfg. AMG, Rx Only. 

55) Avalide, Irbesartan/HCTZ, 150/12.5MG TAB, Mfg. BRI, NDC 00087-2775-31, Rx Only. 

56) Selegiline HCl, 5MG TAB, Mfg. A-C, NDC 60505-3438-03, Rx Only. 

57) Risperidone, 3MG TAB, Mfg. TEV, NED 00093-7242-06, Rx Only. 

58) Fleet Pedia-Lax, Liquid Glycerine Suppository, 4ML, Mfg. CBF, NDC 00132-0190-1, OTC. 

59) Chantix, Varenicline, 0.5MG TAB, Mfg. PFZ, NDC 00069-0468-56, Rx Only.

60) Mesalamine, 4G/60ML, Enema, 60ML, Mfg. PRS, Rx Only. 

61) Prempro, Conj. Estrog/M-Progest, 0.3/1.5MG TAB, Mfg. WYEm BDC 00046-0938-09, Rx Only. 

62) Meclizine HCL, 12.5 MG TAB, Mfg. RUG, NDC 00536-3985-01, Rx Only.  

63) Venlafaxine HCl, 100MG TAB, Mfg. TEV, NDC 0093-7383-01, Rx Only. 

64) Capsaicin, 0.025% Topical Cream, Mfg, SLI, OTC. 

65) Claritin-D, Loratadine/P Ephed, 10/240MG TAB, Mfg. SPH, OTC. 

66)  Glyburide, Micronized, sub: Glynase, 3MG TAB, Mfg. MPI, NDC 67253-0462-10, Rx Only. 

67) Levothroid, Levothyroxine Sodium, 137MCG TAB, Mfg. FOR, NDC 00456-1331-01, Rx Only. 

68) Levsin, Hyoscyamine, 0.5MG/ML, AMP, Mfg. SWZ, Rx Only.    

69) Flavoxate HCl, 100MG TAB, Mfg. GLO, NDC 00115-1811-72, Rx Only. 

70) Midodrine, 2.5MG TAB, Mfg. MYL, NDC 00378-1901-01, Rx Only.

71) Primidone, 50MG Tablet, Mfg. QLT, Rx Only. 

72) Actos, Pioglitazone HCl, 30MG Tablet, Mfg. TPA, NDC 64764-0301-48, Rx Only. 

73) Prochlorperazine Suppository, 25MG, Mfg. PAD, Rx Only. 

74) Vitamin E, 400IU CAP, Mfg. MAJ, NDC 00904-0274-72, OTC. 

75) Diltiazem ER, ONCE-A- DAY DOSAGE, 180MG CAP, Mfg. TEV, NDC 0093-5117-98, Rx Only. 

76) Pancrease MT-4, Pancrelipase CAP, Mfg. JOM, Rx Only. 

77) Accolate, Zafirlukast, 10MG TAB, Mfg. ZNC, NDC 00310-0401-60, Rx Only. 

78) Avapro, Irbesartan, 300MG TAB, Mfg. BRI, NDC 00087-2773-32, Rx Only. 

79) Declofenac DR, sub: Voltaren, 50MG EC TAB, Mfg. APH. NDC 00228-2550-11, Rx Only. 

80) Nitroglycerin, Extended-Release, 2.5MG CAP, Mfg. ETH, NDC 58199-0004-03, Rx Only. 

81) Synthroid, Levothyroxine Sod, 112MCG TAB, Mfg. ABB, NDC 00074-9296-13, Rx Only. 

82) Cimetidine HCl, 300Mg/5ML SOLUTION, 5ML, Mfg. MGP, NDC 60432-0007-08, Rx Only. 

83) Carbamazepine, sub: Tegretol, 200MG TAB, Mfg. TAR, NDC 51672-4005-01, Rx Only. 

84) Venlafaxine HCl, 25MG, TAB, Mfg. TEV, NDC 00093-0199-01, Rx Only. 

85) L-Arginine, 500MG TAB, Mfg. MAJ, NDC 00904-4215-51, OTC. 

86) Etodolac, 400MG RAB, Mfg. SDZ, NDC 00185-0140-01, Rx Only. 

87) Mephyton, Phytonadione, 5MG TAB, Mfg. MER, NDC 25010-0405-15, Rx Only

88) Sulfasalazine, 500Mg TAB, Mfg. WAT, NDC 00591-0786-01, Rx Only. 
 
89) Culturelle, Lactobacillus GG, CAP, Mfg AMF, OTC. 

90) Aspirin, Enteric Coated, 325MG TAB, Mfg. S/B, NDC 15127-0000-04, OTC. 

91) Misoprostol, 100MCG TAB, Mfg. IVX, MDC 00172-4430-59, Rx Only. 

92) Phenazopyridine, 100MG TAB, Mfg. BRK, NDC 51991-0520-01, Rx Only. 

93) Coreg CR, Carvedilol E-R, 40MG CAP, Mfg. SKB, NDC 00007-0072-13, Rx Only. 

94) Levothroxine, sub Synthroid, 175MCG (0.175MG) TAB, Mfg. LAN, NDC 00527-1350-01, Rx Only. 

95) Nepho-Vite RX, TAB, Mfg. NEX, NDC 52544-0977-01, Rx Only. 

96) Januvia, Sitagliptin Phos, 50MG TAB, Mfg. MSD, NDC 0006-112-21, Rx Only. 

97) Sulfamethoxazole/TMP, SMZ/Trimethoprim, 800/160MG TAB, Mfg. MUT, NDC 53489-0146-01, Rx Only. 

98) Calcium Citrate, Sugar/Dye Free, 950MG CAPLET, Mfg. GDL, NDC 00182-4151-01, OTC. 

99) Metanx, TAB, Mfg. PAN, NDC 00525-8019-90, OTC. 

100) Benazepril HCl, sub: Lotensin, 5MG TAB, Mfg. A-C, NDC 60505-0265-01, Rx Only. 

101) Avodart, Dutasteride, 0.5MG CAP, Mfg. GSK, NDC 00173-0712-04, Rx Only.

102) Rifampin, 150MG CAP, Mfg. SNZ, NDC 00185-0801-30, Rx Only. 

103) Nephrocap, CAP, Mfg. FLE, NDC 00256-0185-04, Rx Only. 

104) Aspirin, 81MG TAB, Mfg. GDD, NDC 00113-0274-68, OTC.

105) Potassium Gluconate, (Potassium=99MG), 595MG TAB, Mfg. N-B, NDC 74312-0011-10, OTC. 

106) Prednisolone, sub: Prelone, 5MG/5ML, LIQUID, Qty 5ML, Mfg. ETH, Rx Only. 

107) Domeboro Powder, Mfg BAY, OTC. 

108) Prednisolone, 15MG/5ML SYRUP, 5ML, Mfg. HTP, NDC 50383-0042-24, Rx Only. 

109) Sensipar, Cinaclacet, 30MG Tablet, Mfg. AMG, NDC 55513-0073-30, Rx Only. 

110) Requip, Ropinirole HCl, 4MG TAB, Mfg. GSK, Rx Only. 

111) Risperidone, 0.25MG TAB, Mfg. TEV, NDC 00093-0221-06, Rx Only. 

112) Lipitor, Atorvastatin, 80MG TAB, Mfg. PFZ, Rx Only.

113) Welchol, Colesevelam HCl, 625MG Tablet, Mfg. DSI, NDC 65597-0701-18, Rx Only. 

114) Actonel, Risedronate Sod, 35MG TAB, Mfg. P&G, NDC 00149-0472-01, Rx Only. 

115) Nitro-Dur, Nitroglycerin, 0.3MG/HR PATCH, Mfg. KEY, Rx Only. 

116) Calcium Polycarbphl, sub: Fibercon, 625MG TAB, Mfg, G-S, NDC 00113-0477-75, OTC. 

117) Butalbital/APAP/CAF, 50/325/40MG TAB, Mfg. MAJ, NDC00904-3280-60, Rx Only. 

118) Sulfamethox/TMP, sub: Septra, 200/40MG/5ML SUSP, 5ML, Mfg. HTP, NDC 50383-0824-16, Rx Only. 

119) OYS Shell Calcium+D, 500MG/400IU TAB, Mfg. NVC, NDC 79854-0016-80, Rx Only. 

120) Quinapril HCl, 40MG TAB, Mfg. A-C, NDC 60505-0175-00, Rx Only.

121) Mirapex, Pramipexole DHCL, 0.125MG TAB, Mfg. BOE, NDC 00597-0183-90, Rx Only. 

122) Nifedipine, Extended-Release, 30MG TAB, Mfg. MYL, NDC 00378-3475-01, Rx Only. 

123) Levothyroxine Sodium, sub: Synthroid TAB, 112MCG (0.112MG), Mfg. LAN, NDC 00527-1346-01, Rx Only. 

124) Synthroid, Levothyroxine, 137MCG TAB, Mfg. ABB, NDC 00074-3727-13, Rx Only. 

125) Guaifenesin/DM SF, sub: Robitussin DM SF, 200/20/10ML, SYR, 10ML, Mfg. GDD, NDC 00113-0578-26, OTC. 

126) Kaopectate, Bismuth Subsalicylate, 262MG/15ML LIQ, 15ML, Mfg. CHA, NDC 04116-7605-02, OTC. 

127) Meclizine HCl, 25MG TAB, Mfg. PAR, NDC 49884-0035-01, Rx Only. 

128) Imitrex Nasal Spray, Sumatriptan, 20MG SPRAY, Mfg. GSK, Rx Only.

129) Enablex ER, Darifenacin ER, 7.5MG TAB, Mfg. NVT, NDC 00078-0419-15, Rx Only. 

130) Glimepiride, 1MG Tablet, Mfg. PRS, Rx Only. 

131) Famciclovir, 500MG Tablet, Mfg. TEV, NDC 00093-8119-56, Rx Only. 

132) Tandem OB, Prenatal VIT W/FE, Capsule, Mfg. USP, NDC 52747-0903-60, Rx Only. 

133) Glycopyrrolate, sub: Robinul, 1MG TAB, Mfg. RIS, NDC 64980-0131-01, Rx Only.

134) Tegretol-XR, Carbamazepine E-R, 200MG TAB, Mfg. NVT, Rx Only. 

135) Feosol TAB, Ferrous Sulfate, 325MG (65MG FE), Mfg. GSK, NDC 49692-0942-25, OTC. 

136) Actos, Pioglitazone, 30MG Tablet, Mfg. TPA, NDC 64764-0301-14, Rx Only. 

137) Simethicone, Infants, 40MG/0.6ML DROP, 30ML, Mfg. MAJ, OTC. 

138) Lansinoh, Lanolin, 1/4oz, Mfg. LLI, OTC. 

139) Pangestyme CN-10, Pancrelipase CAP, Mfg. KVP, NDC 58177-0029-04, Rx Only. 

140) Vitamin B Complex, Timed Release, B-100 TAB, Mfg NVC, NDC 79854-0200-96, OTC. 

141) Levothroid, Levothyroxine, 80MDG Tablet, Mfg. FOR, NDC 00456-1329-01, Rx Only. 

142) Diltiazem SDV, INJECTION, 50MG/10ML VIAL, 10ML, Mfg. BED, Rx Only. 

143) Hydroxychloroquine, sub: Plaquenil, 200MG TAB, Mfg. TEV, NDC 00093-9774-01, Rx Only. 

144) Pindolol, 5MG TAB, Mfg. MYL, NDC 00378-0052-01, Rx Only. 

145) Antacid E/S TABS, Calcium 300MG, CAL CARB 750MG, Mfg. GDL, NDC 00182-1136-94, OTC. 

146) Digoxin, 250MCG TAB, Mfg. LAN, NDC 00527-1325-01, Rx Only. 

147) Vitamin D3, Cholecalciferol, 400IU TAB, Mfg. N-B, NDC 74312-0011-40, OTC. 

148) Prednisolone, 15MG/5ML SOL, 5ML. Mfg. MGP, NDC 60432-0212-08, Rx Only. 

149) Flavoxate HCL, 100MG TAB, Mfg. PAD, NDC 00574-0155-01, Rx Only. 

150) Moexipril HCl, 7.5MG TABLET, Mfg. PAD, NDC 00574-0110-01, Rx Only. 

151) Docusate Calcium, 240MG CAP, Mfg. RUG, NDC 00536-3755-01, OTC. 

152) Stuart Prenatal, Multi Vitamin/Min TAB, Mfg. XAN, NDC 64731-0795-01, Rx Only. 

153) Felodipine ER, 5MG ER, Mfg. MUT, NDC 53489-0369-01, Rx Only. 

154) B Complex and B-12, TAB, Mfg N-B, NDC 74312-0001-90, OTC. 

155) Vitamin E, Softgels, 400 IUNIT CAP, Mfg. NVC, NDC 79854-0900-25, OTC. 

156) Vit B Complex w/C, sub: Nephro-Vite, TAB, Mfg. NVC, NDC 79854-0012-69, OTC. 

157) Methergine, Methergonovine, 0.2MG TAB, Mfg. NVT, NDC 00078-0054-05, Rx Only.
CODE
1) Mfg. Lot A080036A, Exp. 09/23/09;
2) Mfg. Lot 21017301, Exp, 09/24/09;
3) Mfg. Lot 3004309, Exp. 09/24/09;
4) Mfg. Lot 801796, Exp. 09/24/09;
5) Mfg. Lot R14068, Exp. 09/23/09;
6) Mfg. Lot 324005, Exp. 09/24/09;
7) Mfg. Lot 081425, Exp. 09/23/09;
8) Mfg. Lot 64735A, Exp. 09/24/09;
9) Mfg. Lot P50438, Exp. 09/24/09;
10) Mfg. Lot 306856, Exp. 09/24/09;
11) Mfg. Lot 8FB53, Exp. 09/24/09;
12) Mfg. Lot 266068C, Exp. 09/24/09;
13) Mfg. Lot 070823, Exp. 09/24/09;
14) Mfg. Lot HR6800, Exp. 09/24/09;
15) Mfg. Lot 8HG745, Exp. 09/24/09;
16) Mfg. Lot 6718010, Exp. 09/24/09;
17) Mfg. Lot 13118050, Exp. 09/24/09;
18) Mfg. Lot 14G004, Exp. 08/01/09;
19) Mfg. Lot 3004643, Exp 09/24/09;
20) Mfg. Lot 701120, Ex. 09/30/09;
21) Mfg. Lot 8010591, Exp 10/01/09;
22) Mfg. Lot 29730, Exp. 09/30/09;
23) Mfg. Lot 175717, Exp. 10/01/09;
24) Mfg. Lot 307476, Exp. 10/01/09;
25) Mfg. Lot HW0613, Exp. 10/01/09;
26) Mfg. Lot 16G147, Exp. 10/01/09;
27) Mfg. Lot CPD890, Exp. 10/01/09;
28) Mfg. Lot. P14294, Exp. 09/30/09;
29) Mfg. Lot 24880, Exp. 10/01/09;
30) Mfg. Lot 18315301, Exp. 09/30/09;
31) Mfg. Lot 269133, Exp. 10/01/09;
32) Mfg. Lot P08D012, Exp 09/01/09;
33) Mfg. Lot 8G13, Exp.07/01/10;
34) Mfg. Lot 307517, Exp. 09/29/09;
35) Mfg. Lot 8570121A, Exp. 09/30/09;
36) Mfg. Lot 8723521506, Exp. 09/26/09
37) Mfg. Lot 738F81, Exp. 09/29/09;
38) Mfg. Lot 08F001, Exp. 09/29/09;
39) Mfg. Lot 174841, Exp. 09/30/09;
40) Mfg. Lot C81308, Exp. 09/26/09;
41) Mfg. Lot 08E259, Exp. 09/29/09;
42) Mfg. Lot F1009UI, Exp. 09/29/09;
43) Mfg. Lot 080842, Exp. 09/30/09;
44) Mfg. Lot 000029752. Exp. 09/26/09;
45) Mfg. Lot U305901, Exp. 09/29/09;
46) Mfg. Lot 210108001, Exp 01/01/11;
47) Mfg. Lot AA3256, Exp 09/30/09;
48) Mfg. Lot 21587801. Exp. 09/29/08;
49) Mfg. Lot 1835095, Exp. 09/29/09;
50) Mfg. Lot 500156, Exp. 02/01/11;
51) Mfg. Lot ZH27, Exp. 09/30/09;
52) Mfg. Lot P08E025, Exp. 09/29/09;
53) Mfg. Lot 27040587A, Exp. 09/29/09;
54) Mfg. Lot D1033277, Exp. 09/30/09;
55) Mfg. Lot 8G2081A, Exp 09/30/09;
56) Mfg. Lot HP0077, Exp. 10/01/09;
57) Mfg. Lot R46015, Exp. 10/23/09;
58) Mfg. Lot 0800710, Exp. 07/01/09;
59) Mfg. Lot 710285831, Exp. 08/01/09;
60) Mfg. Lot 500159, Exp. 02/01/10;
61) Mfg. Lot C75299, Exp. 09/01/09;
62) Mfg. Lot 08H468, Exp. 10/22/09;
63) Mfg. Lot 05W014, Exp. 10/22/09;
64) Mfg. Lot 1003208, Exp. 03/01/09;
65) Mfg. Lot 8DCS48, Exp. 02/01/11;
66) Mfg. Lot 08T7611A, Exp. 10/22/09;
67) Mfg. Lot 050823, Exp. 10/01/09;
68) 11028, Exp. 01/01/10;
69) Mfg. Lot 8010201, Exp. 10/22/09;
70) Mfg. Lot 3002280, Exp. 10/22/09;
71) Mfg. Lot T107D08A, Exp. 10/23/09;
72) Mfg. Lot A14215, Exp. 10/22/09;
73) Mfg. Lot 8253344, Exp. 05/01/10;
74) Mfg. Lot 66527, Exp. 10/01/09;
75) Mfg. Lot P0805T05, Exp. 10/22/09;
76) Mfg. Lot 8HG774, Exp. 10/23/09;
77) Mfg. Lot 107608, Exp. 10/23/09;
78) Mfg. Lot 8G2010A, Exp. 10/22/09;
79) Mfg. Lot 187H81, Exp. 10/29/09
80) Mfg. Lot M110TA, Exp. 10/29/09;
81) Mfg. Lot 67158A8, Exp 04/22/09;
82) Mfg. Lot 29369A, Exp. 10/29/09;
83) Mfg. Lot 089804, Exp. 10/29/09;
84) Mfg. Lot 01V009, Exp. 10/29/09;
85) Mfg. Lot 12145702, Exp. 10/28/09;
86) Mfg. Lot ML080544, Exp 10/29/09;
87) Mfg. Lot 7N526, Exp 10/29/09;
88) Mfg. Lot 3065430, Exp. 10/29/09;
89) Mfg. Lot 0349B8, Exp. 09/30/09;
90) Mfg. Lot 8F22525, Exp. 10/29/09;
91) Mfg. Lot BEF38A, Exp. 10/29/09;
92) Mfg. Lot 082587, Exp 10/29/09;
93) Mfg. Lot X5783, Exp. 10/28/09;
94) Mfg. Lot 024608, Exp. 10/29/09;
95) Mfg. Lot 325079, Exp. 10/29/09;
96) Mfg. Lot X4599, Exp. 10/29/09;
97) Mfg. Lot 62055, Exp. 10/28/09;
98) Mfg. Lot 8741450911, Exp. 10/29/09;
99) Mfg. Lot 0608004, Exp 10/29/09;
100) Mfg. Lot HX5819, Exp. 10/28/09;
101) Mfg. Lot 131615, Exp. 10/28/09;
102) Mfg. Lot ML080531, Exp, 10/29/09;
103) Mfg. Lot 0801902, Exp. 10/02/09;
104) Mfg. Lot 8DE0795, Exp. 10/28/09;
105) Mfg. Lot 17675308, Exp. 10/28/09;
106) Mfg. Lot 91554, Ex. 10/29/09;
107) Mfg. Lot 272568J, Exp. 07/31/11;
108) Mfg. Lot 818042, Exp. 10/27/09;
109) Mfg. Lot D092757, Exp. 10/27/09;
109) Mfg. Lot D092757, Exp. 10/27/09;
110) Mfg. Lot X7825A, Exp. 10/28/09;
111) Mfg. Lot R43014, Exp. 10/27/09;
112) Mfg. Lot 13398V, Exp. 10/28/09;
113) Mfg. Lot JW59, Exp. 10/27/09
114) Mfg. Lot 329232, Exp. 10/27/09;
115) Mfg. Lot DCBU2311, Exp. 09/30/09;
116) Mfg. Lot 7KE0198, Exp. 10/27/09;
117) Mfg. Lot F080234B, Exp. 10/27/09;
118) Mfg. Lot 832824, Exp. 10/28/09;
119) Mfg. Lot 10099, Exp. 10/28/09;
120) Mfg. Lot HY4738, Exp. 10/28/09;
121) Mfg. Lot 856580C, Exp. 10/27/09
122) Mfg. Lot 05218V, Exp. 10/28/09;
123) Mfg. Lot 013808, Exp. 10/28/09;
124) Mfg. Lot 66318A8, Exp. 03/14/09;
125) Mfg. Lot 8GK0379, Exp. 10/28/09;
126) Mfg. Lot 0AHX6, Exp. 09/30/09;
127) Mfg. Lot 21082801, Exp 10/27/09;
128) Mfg. Lot D474, Exp. 04/30/10;
129) Mfg. Lot F0066, Exp. 10/28/09;
130) Mfg Lot 1117140, Exp. 10/27/09;
131) Mfg. Lot 35304265A, Exp. 10/24/09;
132) Mfg. Lot 07121202, Exp. 10/01/09;
133) Mfg. Lot CPD886, Exp. 10/23/09;
134) Mfg. Lot F0016, Exp. 10/27/09;
135) Mfg. Lot 8F05, Exp. 10/24/09;
136) Mfg. Lot A14457, Exp. 10/24/09;
137) Mfg. Lot H810, Exp. 08/01/10;
138) Mfg. Lot 32270, Exp 07/31/11;
139) Mfg. Lot 90110, Exp. 10/24/09;
140) Mfg. Lot 8FB42, Exp 10/24/09;
141) Mfg. Lot 080819, Exp. 07/01/09;
142) Mfg. Lot 1156424, Exp. 10/27/09;
143) Mfg. Lot 30200262A, Exp. 10/24/09;
144) Mfg. Lot 3T0065, Exp. 10/24/09;
145) Mfg. Lot 1279004, Exp. 10/23/09;
146) Mfg. Lot 017308, Exp. 10/24/09;
147) Mfg. Lot 18025503, Exp. 10/24/09;
148) Mfg. Lot 29451A, Exp. 10/24/09;
149) Mfg. Lot E080179A, Exp. 10/23/09;
150) Mfg. Lot 8223126, Exp. 10/23/09;
151) Mfg. Lot 09418060, Exp. 10/24/09;
152) Mfg. Lot 08D027, Exp. 10/24/09;
153) Mfg. Lot 61403, Exp. 10/24/09;
154) Mfg. Lot 17303302, Exp. 10/24/09;
155) Mfg. Lot 8DB29, Exp. 10/24/09;
156) Mfg. Lot 8FB43, Exp. 10/23/09;
157) Mfg. Lot F0117, Exp. 10/23/09
RECALLING FIRM/MANUFACTURER
Advantage Dose LLC, Shreveport, LA, 
REASON Non-Compliance with current Good Manufacturing Practices (GMPs).
VOLUME OF PRODUCT IN COMMERCE
2,635,663 unit doses
DISTRIBUTION Nationwide

PRODUCT 
1) BD Glucose, Dextrose, 5GM TAB, Mfg. B-D, 

2) Benazepril HCl, 10 MG TAB, Mfg. A-C, NDC 60505-0266-01. 

3) Certavite SR W/LUT, Multivit. U/MIN/LUT TAB, Mfg. MAJ, NDC 00904-5486-52. 

4) Ferrlecit, 62.5MG/5ML AMP, 5ML, Mfg. WAT, NDC 2544-922-26. 

5) Lipitor, Atorvastatis Ca, 40 MG TAB, Mfg. PFZ, NDC 00071-0157-23. 

6) Sotalol HCl, sub: BETAPACE, 80MG TAB, Mfg. SDZ, NDC 00185-171-01. 

7) Isopto Homatropine, 5% OPHTH DROP, 5ML, Mfg. ALC. 

8) Hydralazine HCl, 25 MG TAB, Mfg. HPI, NDC 23155-0002-01. 

9) Prandin, Repaglinide, 1MG TAB, Mfg. NPH, NDC 00169-0082-81. 

10) Medroxyprogesterone Injection, 150MG/ML Vial, Advantage Dose not on label. 

11) Metoprolol Succinate, Extended-Release, 50 MG TAB; Mfg. PAR, NDC 49884-0405-01. 

12) Phenazopyridine Plus Tab, Mfg. BRK, NDC 51991-0255-33. 

13) Calcium Acetate, 667 MG CAP, Mfg. ROX, NDC 00054-0088-26. 

14) Avitene, 1 GM JAR, Mfg. DAV. 

15) Prenate Elite, Prenatal Vitamins TAB, Mfg. SPI. 

16) Orphenadrine ER, Orphenadrine Citrate, 100MG TAB, Mfg. GLO, NDC 00115-2011-01. 

17) Chromagen Caplet, Mfg. TRC, NDC 64011-0198-26.  

18) Revatio, Sildenafil Citr, 20 MG TAB, Mfg. PFZ, NDC 00069-4190-68. 

19) Actos, Pioglitazone, 45 MG TAB, Mfg TPA, NDC 64764-0451-24. 

20) Colestipol HCl, Tablet 1G, Mfg. GLO, NDC 00115-5211-15.

21)Thermazene, Silver Sulfadiazine, 1% 20GM Cream, Mfg. KEN. 

22) Acetaminophen Suppository, 325 MG, Mfg. GDL, 00182-7001-11. 

23) Lamictal, Lamorigine, 25 MG Tablet, Mfg. GSK, NDC 00173-0633-02. 

24) Glipizide ER, Sub: Glucotrol XL, 5 MG TAB, Mfg. GRN, NDC 59762-5032-01. 

25) Acetaminophen Rectal Suppository, Mfg. G&W. 

26) Levothyroxine Tab, 175 MCG (0.175 MG), Mfg. MYL, NDC 00378-1817-01. 

27) Commit Lozenge, Nicotine Polarcrilex, 4 MG LOZ, Mfg. SKB, NDC 00766-1500-20. 

28) Belladonna Alk W/PB, Sub: Donnatal Elixir, Mfg. QLT, NDC 00603-1030-58, 15 ML. 

29) Bismuth Subsalicylate, 262 MG/15 ML Oral, Mfg. GDD, NDC 00113-0302-34, 30 ML. 

30) Levothyroxine Tab, 200 MCG (0.2MG), Mfg. MYL, NDC 00378-1819-01. 

31) Sular, Nisoldipine, 8.5MG ER-TAB, MFG. SPP, NDC 39630-0500-10. 

32) Centrum Multivitamin/Min TAB, Mfg. W-R, NDC 00005-4239-36. 

33) Nephplex Rx, Tab, Mfg. N-T, NDC 59528-0317-01. 

34) Trazodone, Sub: Desyrel, 150 MG TAB, Mfg. A-C, NDC 60505-2655-01.

35) Tekturna, Aliskiren, 150MG TAB, Mfg. NVT, NDC 00078-0485-15. 

36) Aspirin, 325 MG TAB, Mfg. MAJ, NDC 00904-2009-60. 

37) Prograf, Tacrolimus Anhydrous, 0.5 MG CAP, Mfg. ASE, NDC 00469-0607-73. 

38) Tizanidine HCl, sub: Zanaflex, 2 MG TAB, Mfg. SDZ, NDC 00185-0034-51. 

39) HydroOXYzine HCl, Sub: Atarax Tab, 25 MG TABLET, Mfg. PLU, NDC 50111-0308-01. 

40) Mucinex, Guaifenesin ER, 600 MG TAB, Mfg. ADA, NDC 63824-0008-40. 

41) Cellcept, Mycophenolate, 500 MG TAB, Mfg. ROC, NDC 00004-0260-01. 

42) Naproxen Sod, Sup: Anaprox DS, 550 MG TAB, Mfg. W-W, NDC 00143-9908-01. 

43) Diamox Seq ER, Acetazolamide, 500 MG CAP, Mfg. DMD, NDC 51285-0754-02. 

44) Estradiol, Sub: Estrace, 2MG TAB, Mfg. WAT, NDC 00591-0488-01. 

45) Megace ES, Megestrol Acetate, 625 MG/5 ML SUSP, Qty 5 ML, Mfg. PAR, NDC 49884-0949-69. 

46) Ondansetron ODT, 4 MG TAB, Mfg. GPI, NDC 68462-0157-13. 

47) Commit Lozenge, Nicotine Polacrilex, 2 MG LOZ, Mfg. SKB, NDC 00766-1500-10. 

48) Trandolapril, Sub: MAVIK, 2 MG TAB, Mfg. TEV, NDC 00093-7326-01. 

49) Bisac - Evac Bisacodyl, 10 MG Rectal Suppository, Mfg. G&W, 99086. 

50) Levothyroxine Sod Tab, 50 MCG (0.05 MG), Mfg. MYL, NDC 00378-1803-01. 

51) Cellcept, Mycophenolate, 250 MG CAP, Mfg. ROC, NDC 00004-0259-01. 

52) Warfarin Sodium, 6 MG TAB, Mfg. BAR, NDC 00555-0926-02. 

53) Levothyroxine Sod Tab, 25 MCG (0.025MG), Mfg. MYL, NDC 00378-1800-01. 

54) Zinc Sulfate, (Zinc 50 MG), 220 MG CAPSULE, Mfg. MAJ, NDC 00904-5332-60. 

55) Lamictal, Lamotrigine, 200 MG TAB, Mfg. SKB, NDC 00173-0644-60. 

56) Levothyroxine Sod Tab, 75 MCG (0.075MG), Mfg. MYL, NDC 00378-1805-01. 

57) Isosorbide Mono, 20 MG TAB, Mfg. ACT, NDC 00228-2620-11. 

58) Topamax, Topiramate, 200 MG TAB, Mfg. JOM, NDC 00045-0642-65. 

59) Ticlopidine HCl, 250 MG TAB, Mfg. A-C. 

60) Levothyroxine Sod Tab, 125 MCG (0.125MG), Mfg. MYL, NDC 00378-1813-01.

61) NAC, N-Acetyl-Cysteine, 600 MG CAP, Mfg. TWI, NDC 02743-4002-11. 

62) Isosorbide Mono, 10 MG TAB, Mfg. ACT, NDC 00228-2631-11. 

63) Vistide SDV, Cidofovir, 75 MG/ML Vial, 5 ML, Mfg. GSI. 

64) Levothyroxine Sod Tab, 100 MCG (0.1 MG), Mfg. MYL.

65) Levothyroxine Tablet, 300 MCG (0.3MG), Mfg. MYL, NDC 00378-1821-01. 

66) Keppra, Levetiracetam, 750 MG TAB, Mfg. UCB, NDC 50474-0596-40. 

67) Carvedilol, 6.25 MG TAB, Mfg. AUP, NDC 65862-0143-01. 

68) Vfend, Voriconazole, 200 MG TABLET, Mfg. PFZ, NDC 00049-3180-30.;

69) Levothyroxine Sod Tab, 150 MCG (0.15MG), Mfg. MYL, NDC 00378-1815-01.

70) Valcyte, Valganciclovir, 450 MG TABLET, Mfg. ROC, NDC 00004-0038-22.

71) Midazolam HCL, Oral Syrup, 2MG/ML CIV, Qty 5 ML, Mfg. ROX, NDC 00054-3566-99. 

72) Kaletra, Ritonavir/Lopinavir Tab, 50 MG/200 MG, Mfg. ABB, NDC 00074-6799-22. 

73) Cyclobenzaprine HCL, 5 MG TAB, Mfg. BRK, NDC 51991-0467-01. 

74) Warfarin Sodium, 5 MG TAB, Mfg. BAR, NDC 00555-0833-02. 

75) Amlodipine/Benazepril, 5/20 MG CAP, Mfg. SNZ, NDC 00781-2273-01. 

76) Estradiol, 1 MG TAB, Mfg. WAT, NDC 00591-0487-01. 

77) Zinc Gluconate Tab, 50 MG ZINC, Mfg. NVC, NDC 79854-0500-75. 

78) Prednisolone Oral Solution, 15 MG/5ML, Mfg. TEV, NDC 00093-6118-16, 5ML. 

79) Centrum Silver TAB, Mfg. Lot C76264A, Mfg. U-R, NDC 00005-4177-23. 

80) Aspirin, Enteric Coated, 325 MG TAB, Mfg. MAJ, NDC 00904-2011-59.

81) Menest, Estrogens, Esterif, 0.625 MG TAB, Mfg. MNR, NDC 61570-0073-01. 

82) Starlix, Nateglinide, 60 MG TAB, Mfg. NVT, 54523. ;

83) Balsalazide Disodium, 750 MG CAP, Mfg. WAT, NDC 00591-3570-35. 

84) Albuterol Sulf, Strawberry, 2 MG/5ML Solution, Qty 5ML, Mfg. QLT, NDC 00603-1008-58. 

85) Diclofenac Sod DR, Enteric Coated, 75 MG TAB, Mfg. ACT, NDC 00228-2551-06. 

86) Reyataz, Atazanavir Sulf, 200 MG CAP, Mfg. BRI, 31247. 

87) Metoprolol Tart, 25 MG TAB, Mfg. C-P, NDC 57664-0506-08. 

88) Mexiletine HCl, 150 MG CAP, Mfg. TEV, NDC 00093-8739-01. 

89) Gelfilm, Opth Film, Gelatin Film 2 sq in, Mfg. PFZ.  

90) Prednisolone SOL, Sub: Prelone, 15 MG/5ML ORAL, 5ML, Mfg. TEV, NDC 00093-6118-87. 

91) Zinc Sulfate (Zinc 50 MG), 220 MG CAP, Mfg. CYP, NDC 60258-0131-01. 

92) Amlodipine/Benazepril, 5/10 MG CAP, Mfg. SNZ, NDC 00781-22720-01.

93) Drisdol Cap, Ergocalciferol (Vit D), 50,000 IU (1.25MG), Mfg. RPS, 99607. 

94) Nitroglycerin Extended Release, 9 MG CAP, Mfg. Lot L054T, Exp 11/10/09, Mfg. ETH, NDC 58177-0006-04. 

95) Synthroid Tab, Levothyroxine, 0.088MG (88MCG), Mfg. ABB, NDC 00074-6594-13. 

96) Quinidine Sulf, 200 MG TABLET, Mfg. WAT, NDC 00591-5438-01. 

97) Simethicone, 125 MG SOFTGEL, Mfg. GOD, NDC 00113-0428-65. 

98) OS-CAL +D, Calcium + Vit D, 500MG/200IU TAB, Mfg. GSK. 

99) Sudogest, Pseudoephedrine, 30 MG TAB, Mfg. MAJ, NDC 00904-5053-59. 

100) Novolog, Insulin Aspart Inj., 100 U/ML Vial 10 ML, Mfg. NPH, NDC 00169-7501-11.

101) Lamotrigine, 100 MG TAB, Mfg. TEV, NDC 00093-0463-01.

102) Didronel, Etidronate Disodium, 400 MG TAB, Mfg. P&G, NDC 00149-0406-60. 

103) Hyoscyamine ODT, 0.125 MG TAB, Mfg VPH, NDC 68013-0005-01. 

104) Apidra, Insulin Glulisine, 100 Units/ML INJ 10 ML, Mfg. AVE, NDC 00088-2500-33. 

105) Propantheline, Sub: Pro-Banthine, 15 MG TAB, Mfg. ROX, NDC 00054-4721-25. 

106) Promethazine DM Syrup, 6.25 MG/15MG/5ML, Mfg. HTP, NDC 50383-0803-16, 10 ML. 

107) Lantus Injection, 100 Units/ML, 10 ML, Mfg. AVE, NDC 00088-2220-33. 

108) Cytomel, Liothyronine, 25 MCG TAB, Mfg. KPI, NDC 60793-0116-01

109) Humalog Mix 75/25, INJ, 10 ML, Mfg. LIL, NDC 00002-7511-01. 

110) Femara, Letrozole, 2.5 MG TAB, Mfg. NVT, NDC 00078-0248-15. 

111) Didronel, Etidronate Disodium, 200 MG TAB, Mfg. P&G, NDC 00149-0405-60. 

112) Nifedipine, 10 MG CAP, Mfg. ACT, NDC 00228-2497-10.

113) Meclofenamate Sod, 50 MG CAP, Mfg. MYL, NDC 00378-2150-01. 

114) MAG 64, Sub: SLOW MAG, 64 MG TAB, Mfg RIS, NDC 68535-0005-75. 

115) Vitamin C, Ascorbic Acid, 500 MG TAB, Mfg. MAJ, NDC 00904-0523-60. 

116) Oxaprozin, 600 MG TAB, Mfg. RED, NDC 55111-0170-01. 

117) Premarin, Conj. Estrogens, USP, 0.3MG TAB, Mfg. WYE, NDC 00046-1100-01.

118) Cytomel, Liothyronine Sod, 5MCG TAB, Mfg. KPI, NDC 60793-0115-01. 

119) Acetazolamide, 250 MG TAB, Mfg TAR, NDC 51672-4023-01. 

120) Novolog Mix 70/30 INJ, 10 ML, Mfg. NPH, NDC 00169-3685-12. 

121) Mucinex, guaifenesin Oral, 100 MG/5ML Solution, Qty 5ML, Mfg. ADA, NDC 63824-0173-64. 

122) Bisoprolol Fumarate, Sub: Zebeta, 5 MG TAB, Mfg. TEV, NDC 000935270-56. 

123) Rozerem, Rameleon, 8MG TAB, Mfg. TPA, NDC 64764-0805-30. 

124) Levemir, Insulin Detemir, 100 UNITS/ML INJ, 10 ML, Mfg. NPH, NDC 00169-3687-12.

125) Keppra, Levetiracetam, 100 MG/ML Solution, 5ML, Mfg. UCB, NDC 50474-0001-48. 

126) Oxybutynin, Extended-Release, 15 MG TAB, Mfg. MYL, NDC 00378-6015-01. 
CODE
1) Mfg. Lot 1461C1230, Exp. 04/04/10;
2) Mfg. Lot HU7302, Exp. 11/07/09,
3) Mfg. Lot 27980, Exp. 11/07/09;
4) Mfg. Lot D7A342, Exp. 03/31/11;
5) Mfg. Lot 0627058, Exp. 11/07/09;
6) Mfg. Lot 177412, Exp 11/06/09;
7) Mfg. Lot 139296F, Exp. 02/28/10;
8) Mfg. Lot 6127005A, Exp 11/07/09;
9) Mfg. Lot 706756B, Exp. 11/06/09;
10) Mfg. SPI, Mfg. Lot 31302127B, Exp. 05/31/10;
11) Mfg. Lot PL0128, Exp 11/07/09;
12) Mfg. Lot PP00208, Exp. 11/07/09;
13) Mfg. Lot 856122A, Exp. 11/07/09;
14) Mfg. Lot WBSCFD12, Exp. 03/31/11;
15) Mfg. Lot ZC22, Exp. 01/31/10;  
16) Mfg. Lot 8022651, Exp 11/07/09;
17) Mfg. Lot 90806, Exp 11/07/09;
18) Mfg. Lot 8236805, Exp 11/06/09;
19) Mfg. Lot A14656, Exp 11/07/09;
20) Mfg. Lot 8090281, Exp. 11/07/09;
21) Mfg. Lot 820534, Exp. 08/31/11;
22) Mfg. Lot 016408002, Exp. 03/31/12;
23) Mfg. Lot 8ZP808, Exp. 11/07/09;
24) Mfg. Lot 10968V, Exp. 11/06/09;
25) Mfg. Lot 016408005, Exp. 05/31/12;
26) Mfg. Lot 3002998, Exp. 11/10/09;
27) Mfg. Lot 8B27, Exp 11/10/09;
28) Mfg. Lot L038G08A, Exp. 11/07/09;
29) Mfg. Lot 8AK0217, Exp. 11/07/09;
30) Mfg. Lot 3005319, Exp. 11/10/09;
31) Mfg. Lot 2017178, Exp. 09/30/09;
32) Mfg. Lot C23095, Exp. 11/07/09;
33) Mfg. Lot 0801, Exp. 11/10/09;
34) Mfg. Lot 306813, Exp. 11/07/09;
35) Mfg. Lot F0066, Exp. 11/07/09;
36) Mfg. Lot 3278, Exp. 11/07/09;
37) Mfg. Lot 034471, Exp. 11/07/09;
38) Mfg. Lot ME080083, Exp. 11/07/09;
39) Mfg. Lot 307300, Exp. 11/07/09;
40) Mfg. Lot PL00007951, Exp. 11/07/09;
41) Mfg. Lot U0979, Exp 11/10/09;
42) Mfg. Lot ND453B, Exp. 11/07/09;
43) Mfg. Lot 701367, Exp 11/07/09;
44) Mfg. Lot 48802M07, Exp. 11/07/09;
45) Mfg. Lot 19508101, Exp. 11/10/09;
46) Mfg. Lot Q10148018, Exp. 07/31/10;
47) Mfg. Lot 8B19, Exp. 11/10/09;
48) Mfg. Lot T22026, Exp. 11/07/09;
49) Mfg. Lot 010908006, Exp. 04/30/11;
50) Mfg. Lot 3003648, Exp. 11/10/09;
51) Mfg. Lot U1070, Exp. 11/10/09;
52) Mfg. Lot 701265, Exp. 11/10/09;
53) Mfg. Lot 3004424, Exp. 11/10/09;
54) Mfg. Lot 18029105, Exp. 11/10/09;
55) Mfg. Lot 8ZP7593, Exp. 11/10/09;
56) Mfg. Lot 3004069, Exp. 11/10/09;
57) Mfg. Lot 178H81, Exp. 11/10/09;
58) Mfg. Lot 8JG926, Exp. 11/10/09;
59) Mfg. Lot HN9113, Exp. 11/10/09;
60) Mfg Lot 3004586, Exp. 11/10/09;
61) Mfg. Lot 208471045, Exp. 11/10/09;
62) Mfg. Lot 475J81, Exp. 11/10/09;
63) Mfg. Lot 944279, Exp. 05/31/10;
64) Mfg. Lot 3004904, Exp. 11/10/09;
65) Mfg. Lot 3004664, Exp. 11/10/09;
66) Mfg. Lot 47908, Exp. 11/07/09;
67) Mfg. Lot CU0607008, Exp. 10/31/09;
68) Mfg. Lot 810312330, Exp. 11/10/09;
69) Mfg. Lot 3003210, Exp. 11/10/09;
70) Mfg. Lot B1049, Exp. 11/10/09;
71) Mfg. Lot 856964A, Exp. 11/10/09;
72) Mfg. Lot 64845AA40, Exp. 11/10/09;
73) Mfg. Lot AE060, Exp. 11/10/09;
74) Mfg. Lot 307460, Exp. 11/10/09;
75) Mfg. Lot F1015, Exp 11/10/09;
76) Mfg. Lot 48702K07, Exp. 10/31/09;
77) Mfg. Lot 7FC80, Exp. 11/10/09;
78) Mfg. Lot 30201673A, Exp. 11/11/09;
79) Mfg. Lot C76264A, Exp 11/10/09;
80) Mfg. Lot A194U, Exp 11/11/09;
81) Mfg. Lot 52693, Exp 11/10/09;
82) Mfg. Lot F0105, Exp. 11/10/09;
83) Mfg. Lot 320667, Exp 11/11/09;
84) Mfg. Lot L057G08A, Exp. 11/11/09;
85) Mfg. Lot 225H81, Exp 11/10/09;
86) Mfg. Lot 8C3048A, Exp 11/10/09;
87) Mfg. Lot 81739A, Exp 11/11/09;
88) Mfg. Lot 35303681A, Exp. 11/10/09;
89) Mfg. Lot 0APTY, Exp. 03/31/11;
90) Mfg. Lot 30202639A, Exp. 11/11/09;
91) Mfg. Lot 28104, Exp 11/10/09;
92) Mfg. Lot F1005, Exp 11/10/09;
93) Mfg. Lot 256797N, Exp 08/31/09;
94) Mfg. Lot L054T, Exp 11/10/09;
95) Mfg. Lot 69006A8, Exp. 05/26/09;
96) Mfg. Lot 90229A, Exp 11/10/09;
97) Mfg. Lot 8GEO110, Exp. 10/31/09;
98) Mfg. Lot 8A21, Exp. 11/10/09;
99) Mfg. Lot P50366, Exp 11/11/09;
100) Mfg. Lot VZF0216, Exp. 11/30/10;
101) Mfg. Lot 24L007, Exp. 11/11/09.
102) Mfg. Lot 435029, Exp. 11/11/09;  
103) Mfg. Lot C08013, Exp. 11/11/09;
104) Mfg. Lot 40U064, Exp. 06/30/10;
105) Mfg. Lot 857129A, Exp. 11/11/09;
106) Mfg. Lot 884803, Exp 1/11/09;
107) Mfg. Lot 40U339, Exp. 05/31/10;
108) Mfg. Lot 53179, Exp 11/11/09;
109) Mfg. Lot A477867C, Exp 01/31/10,
110) Mfg. Lot F4200, Exp. 11/11/09;
111) Mfg. Lot 430539, Exp. 11/11/09;
112) Mfg. Lot 279E81, Exp 11/11/09;
113) Mfg. Lot 3000913, Exp 11/11/09;
114) Mfg. Lot J058T, Exp 11/11/09;
115) Mfg. Lot 18282503, Exp 11/11/09;
116) Mfg. Lot C82088, Exp 11/11/09;
117) Mfg. Lot C88669, Exp 11/11/09;
118) Mfg. Lot 53178, Exp 11/11/09;
119) Mfg. Lot 080288, Exp 11/11/09;
120) Mfg. Lot VZF0225, Exp 06/30/10.
121) Mfg. Lot 804005, Exp 11/11/09.
122) Mfg. Lot 35304576A, Exp. 11/11/09;
123) Mfg. Lot C14058, Exp 11/10/09;
124) Mfg. Lot VZF0247, Exp. 06/30/10;
125) Mfg. Lot 47493, Exp 11/12/09;
126) Mfg. Lot 8DA580, Exp. 08/31/09
RECALLING FIRM/MANUFACTURER
Advantage Dose LLC, Shreveport, LA, 
REASON Not in conformance with cGMPs.
VOLUME OF PRODUCT IN COMMERCE
2,635,663 unit doses
DISTRIBUTION AR, GA, IL, LA, MS, MO, OK, TX

PRODUCT 
1) Allopurinol tablets, USP, 100 mg, Rx, 100 tablet bottles: NDC 57664-434-88 and 1000 tablet bottles: NDC 576644-434-18. 

2) Allopurinol tablets, USP, 300 mg, Rx, 100 tablet bottles: NDC 57664-436-88 and 500 tablet bottles: NDC 576644-436-13. 

3) Atenolol tablets, USP, 25 mg, 1000 tablet bottles, Rx, NDC 57664-264-18.

4) Carbamazepine tablets, USP, 200 mg, 500 tablet bottles, Rx, NDC 13668-268-05.

5) Carvedilol tablets, USP, 3.125 mg, Rx, 100 tablet bottles: NDC 57664-242-88, 500 tablet bottles: NDC 57664-242-13. 1000 tablets: NDC 57664-242-18. 

6) Carvedilol tablets, USP, 6.25 mg, Rx, 100 tablet bottles: NDC 57664-244-88, 500 tablet bottles: NDC 57664-244-13. 09;

7) Carvedilol tablets, USP, 25 mg, Rx, 500 tablet bottles: NDC 57664-247-13, 1000 tablet bottles: NDC 57664-247-18. 

8) Choline Magnesium Trisalicylate tablets, 750 mg, 100 tablet bottles, Rx, NDC 57664-220-08. 

9) Citalopram Hydrobromide tablets, 20 mg, Rx, 100 tablet bottles: NDC 57664-508-88, 500 tablet bottles: NDC 57664-508-13. 1000 tablets: NDC 57664-508-18. 

10) Clonazepam tablets, USP, 0.5 mg, C IV, 500 tablet bottles, Rx, NDC 57664-273-13. 

11) Clozapine tablets, USP, 25 mg, 500 tablet bottles, Rx, NDC 57664-345-13. 

12) Flurbiprofen tablets, USP, 100 mg, 100 tablet bottles, Rx, NDC 57664-165-08. 

13) Hydrochlorothiazide tablets, USP, 25 mg, 1000 tablet bottles, Rx, NDC 57664-428-18. 

14) Hydrochlorothiazide tablets, USP, 50 mg, Rx, 100 tablet bottles: NDC 57664-429-88, 1000 tablet bottles: NDC 57664-429-18. 

15) Meloxicam tablets, 7.5 mg, Rx, 100 tablet bottles: NDC 57664-512-88, 1000 tablet bottles: NDC 57664-512-18. 

16) Meloxicam tablets, 15 mg, Rx, 100 tablet bottles: NDC 57664-513-88, 500 tablet bottles: NDC 57664-513-13, 1000 tablet bottles: NDC 57664-513-18. 

17) Metformin hydrochloride tablets, USP, 500 mg, 1000 tablet bottles, Rx, NDC 57664-397-18. 

18) Metformin hydrochloride tablets, USP, 1000 mg, 1000 tablet bottles, Rx, NDC 57664-474-18. 

19) Metoprolol Tartrate tablets, USP, 25 mg, 1000 tablet bottles, Rx, NDC 57664-506-18. 

20) Metoprolol Tartrate tablets, USP, 50 mg, Rx, 1000 tablet bottles: NDC 57664-166-18, 1000 round tablet bottles: NDC 57664-477-18. 

21) Metoprolol Tartrate tablets, USP, 100 mg, 1000 tablet bottles, Rx, NDC 57664-167-18.  

22) Paromomycin Sulfate capsules, USP, 250 mg, 100 capsule bottles, Rx, NDC 57664-175-08. 

23) Paroxetine tablets, USP, 20 mg, Rx, 30 tablet bottles: NDC 57664-422-83, 90 tablet bottles: NDC 57664-422-99, 500 tablet bottles: NDC 57664-422-13. 

24) Phentermine Hydrochloride tablets, USP, C IV, 37.5 mg, 100 tablet bottles, Rx, NDC 57664-504-88. 

25) Tizanidine Hydrochloride tablets, USP, 4 mg, Rx, 150 tablet bottles: NDC 57664-503-89, 1000 tablet bottles: NDC 57664-503-18. 

26) Tramadol Hydrochloride tablets, 50mg, Rx, 500 tablet bottles: NDC 57664-377-13, 1000 tablet bottles: NDC 57664-377-18. 

27) Tramadol Hydrochloride and Acetaminophen tablets, 37.5 mg/325 mg, Rx, 100 tablet bottles: NDC 57664-537-88, 500 tablet bottles: NDC 57664-537-13. 

28) Zolpidem Tartrate tablets, 5 mg, C IV, Rx, 100 tablet bottles: NDC 57664-515-88, 500 tablet bottles: NDC 57664-515-13. 

29) Zolpidem Tartrate tablets, 10 mg, C IV, Rx, 100 tablet bottles: NDC 57664-516-88, 500 tablets: NDC 57664-516-13. 
CODE
1) Lots 90260A, 90261A and 90262A;

2) Lots 90258A and 90259A;

3) Lot 82645A;

4) Lot 90008A;

5) Lots 90097A, 90098A and 90098B;

6) Lots 90099A, 90100A and 90101A;

7) Lots 90279A, 90278A and 90280A;

8) Lot 90135A;

9) Lots 82805A, 80806A and 80807A;

10) Lots 82797A, 82798A and 82799A;

11) Lot 90119A;

12) Lot 81844A and 82572A;

13) Lots 82830A, 82831A and 82832A;

14) Lot 90130B;

15) Lots 90081A, 90082A, 90083A, 90084A, 90330A and 90331A;

16) Lots 82596A, 82597A, 82597B, 90086A, 90087A, 90088A, 90250A, 90318A, 90320A and 90321A;

17) Lot 82740A;

18) Lots 82850A, 82689A, 90190A and 90191A;

19) Lots 90122A, 90123A and 90124A;

20) Lots 90027A, 90142A and 90210A;

21) Lot 82710A;

22) Lot 90242A;

23) Lots 90028A, 90028B and 90028C;

24) Lots 90089A and 90090A;

25) Lots 82684A, 90116A and 90017A;

26) Lots 82353A, 82355A, 82362A, 82624A, 82630A, 82631A, 82633A, 82634A, 82635A, 90071A, 90072A, 90073A, 90074A, 90075A, 90078A, 90079A and 90080A;

27) Lots 82603A, 82604A, 82820A and 82822A;

28) Lots 90167A, 90168A, 90168B and 90170A;

29) Lots 90030A, 90031A, 90032A, 90033A, 90034A and 90036A
RECALLING FIRM/MANUFACTURER
Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI, 
REASON Lack of assurance products do not contain an additional drug ingredient.
VOLUME OF PRODUCT IN COMMERCE
410,033 bottles
DISTRIBUTION Nationwide

WEEK ENDING JULY 18

PRODUCT 
1) Methyldopa/ HCTZ, 250/25 MG TAB, Mfg. MYL, Rx Only. 

2) Paxil CR, Paroxetine, 37.5 MG TAB, Mfg. GSK, Rx Only. 

3) Levothroid, Levothyroxine Na, 200MCG TAB, Mfg. FOR, Rx Only. 
 
4) Disopyramide PHOS, 100MG CAP, Mfg. WAT, Rx Only.;

5) Depakote, Divalproex Sodium, 125MG TAB, Mfg. ABB, Rx Only. 

6) Loxapine SUC, 25MG CAP, Mfg. WAT, Rx Only. 

7) Gabapentin, 400MG CAP, Mfg. A-C, Rx Only. 

8) Levothyroxine Injection, 200MCG Vial, Mfg. BVL, Rx Only. 

9) Vitamin B-6, Pyridoxine, 50MG TAB, Mfg. V-1, OTC. ;

10) Albuterol Sulf, 2MG TAB, Mfg. URL, Rx Only. 

11) HydrOXYzine Pamoate, sub: VISTARIL, 50MG CAP, Mfg. SDZ, Rx Only. 

12) Zyrtec-D 12 Hour, P-EPHED/CETIRIZINE, 120/5MG TAB, Mfg. PFZ, NDC 00069-1630-66, OTC. 

13) Trifluoperazine, 1MG TAB, Mfg. MYL, Rx Only. 

14) Risperdal, Risperidone, 0.25MG TAB, Mfg. JPP, Rx Only. ;

15) Baclofen, 20MG TAB, Mfg. QLT, NDC 00603-2407-21, Rx Only. 

16) Rifampin, 300MG CAP, Mfg. SDZ, Rx Only. 

17) Amlodipine, Amlodipine Besylate, 5MG TAB, Mfg. MYL, Rx Only. 
 
18) Baclofen, 10MG TAB, Mfg. QLT, NDC 00603-2406-21, Rx Only. ;

19) Excedrin Tension, APAP/ Caffeine, 500/65MG GELTAB, Mfg. NVT, OTC. 

20) Maalox M/S Lemon, Ca CARB/Simethicone, 1000/60MG CHEW TAB, Mfg. NVT, NDC 00067-0371-65, OTC. 

21) Aleve, Naproxen Sodium, 220MG TAB, Mfg. BAY, NDC 32586-6105-05, OTC. 

22) Aspirin Suppositories, 300MG (5 GRAINS), Mfg. PAD, OTC. ;

23) Aplisol SOL, 1CC VL, Tuberculin PPD, Mfg. PPI, Rx Only. 

24) Famotidine, sub: PEPCID AC, 10MG TAB, Mfg. GDL, NDC 00182-2662-19, OTC. 

25) Promethazine, 12.5MG Suppositories, Mfg. PAD, Rx Only. ;

26) Preparation H, Phenylephrine, 0.25% Suppository, Mfg. W-R, OTC. 

27) URO BLUE, TAB, Mfg. RAM, NDC 12830-0301-01, Rx Only. ;

28) Konsyl, Calcium Polycarb, 625MG CAP, Mfg. KON, NDC 00224-0500-90, OTC. 

29) DIPHENhydramine SF AF, sub: Benadryl, 12.5MG/5ML Liquid 5ML, Mfg. IVX, NDC 00182-6168-40, OTC. ;

30) HydrOXYzine HCl, 25MG Tablet, Mfg. WAT, NDC 00591-5523-01, Rx Only. 

31) Paroxetine HCl, 20MG TAB, Mfg. API, NDC 62037-0846-30, Rx Only. 

32) Cerovite Senior, Multivitamin W-MIN, TAB, Mfg. RUG, NDC 00536-3445-08, OTC. 

33) URO-MAG, Magnesium Oxide, 140MG CAP, Mfg. BLA, NDC 00165-0054-01, OTC. 

34) Citalopram, 10MG TAB, Mfg. RED, NDC 55111-0342-01, Rx Only. 

35) Benicar, Olmesartan Medoxomil, 20MG Tablet, Mfg. DSI, NDC 65597-0103-90, Rx Only. 
 
36) Methimazole, sub: Tapazole, 10MG TAB, Mfg. URL, NDC 00677-1946-01, Rx Only. 

37) Lisinopril/HCTZ, 20/12.5 TAB, Mfg. IVX, NDC 00172-5034-60, Rx Only.

38) Isosorbide DIN, Isosorbide Dinitrate: 2.5MG SL TAB, Mfg. QLT, NDC 00603-4122-21, Rx Only. 

39) Zyvox, Linezolid, 600MG TAB, Mfg. PFZ, NDC 00009-5135-02, Rx Only. 

40) Diphenhydramine, 12.5MG/5ML and Alcohol 14%/5ml, 12.5MG/5ML 5ML 5ML, Mfg. 5ml, Rx Only. 

41) Misoprostol, 100MCG TAB, Mfg. GRN, NDC 59762-5007-01, Rx Only. 

42) Tandem DHA, CAP, Mfg. USP, NDC 52747-0904-60, Rx Only

43) Diovan, Valsartan, 80MG TAB, Mfg. NVT, NDC 00078-0358-34, Rx Only. 

44) Ranitidine HCl, sub: Zantac, 300MG TAB, Mfg. SNZ, NDC 00781-1884-25, Rx Only. 

45) Estradiol Trans, 0.05MG/24H PAT, Mfg. MYL, Rx Only. 

46) Avandaryl, Rosiglitazon/Glimep, 4MG/2MG TAB, Mfg. SKB, NDC 00007-3152-13, Rx Only.

47) Tandem CAP, FE Fumarate/FE PS CMPLX, Mfg. USP, Rx Only. ;

48) Travatan OPTH SOL, Travoprost, 0.004% DROP 2.5ML, Mfg. ALC, Rx Only. 

49) Slow FE, Fe S04, 47.5MG, Mfg. NVT, OTC. 

50) GAS-X E/S, Simethicone, 125MG SOFTGEL, Mfg. NVT, OTC. 

51) Aspirin EC, 81MG, Aspirin EC Tablet, Mfg. IVX, OTC. 

52) Stay Awake, Caffeine, 200MG Tablet, Mfg. GDD, OTC.

53) Acetaminophen SUP, 325MG, Acetaminophen Suppos., Mfg. G&W, OTC. 

54) Depakote DR, 125MG Divalproex Tablet, Mfg. ABB, Rx Only. 

55) Eye Wash IRR SOL, 4 OZ, OML, Mfg. GDL, OTC. 9;

56) Dornase ALFA Inhal. Sol., Pulmozyme 2500 U./AMP, Mfg. GNT, Rx Only. 

57) LACT-AID FAST ACT, Lactase, Mfg. MCN, OTC. 
CODE
1) Mfg. Lot 1S1604, Exp. 11/26/08;
2) Mfg. Lot 3087P08, Exp. 11/29/08;
3) Mfg. Lot 100723, Exp. 12/04/08;
4) Mfg. Lot L7B0252, Exp. 11/26/08;
5) Mfg. Lot 53873AA21, Exp. 12/04/08;
6) Mfg. Lot 37101E07, Exp. 11/26/08;
7) Mfg. Lot HL7449, Exp. 12/03/08;
8) Mfg. Lot 1139997, Exp. 08/01/09;
9) Mfg. Lot 300807, Exp. 12/04/08;
10) Mfg. Lot 59821, Exp. 11/27/08;
11) Mfg. Lot ML071390, Exp. 12/03/08;
12) Mfg, Lot 03297L, Exp. 12/05/08;
13) Mfg. Lot 3000661, Exp. 11/25/08;
14) Mfg. Lot 7LG490, Exp. 12/04/08;
15) Mfg. Lot T074G07A, Exp. 12/05/08;
16) Mfg. Lot ML071114, Exp. 11/27/08;
17) Mfg. Lot 3001045, Exp. 12/04/08;
18) Mfg. Lot T072G07C, Exp. 12/05/08;
19) Mfg. Lot 6J4508A, Exp. 12/03/08;
20) Mfg. Lot 10038164, Exp. 12/10/08;
21) Mfg. Lot 251157J, Exp. 12/18/08;
22) Mfg. Lot 7370915, Exp. 08/01/09;
23) Mfg. Lot 46376, Exp. 12/03/08;
24) Mfg. Lot BEAD4B, Exp. 02/01/09;
25) Mfg. Lot 7129497, Exp. 03/01/09;
26) Mfg. Lot C03612A, Exp. 05/01/09;
27) Mfg. Lot 071283, Exp. 12/17108;
28) Mfg. Lot E72602, Exp. 12/06/08;
29) Mfg. Lot 7K04, Exp. 12/10/08;
30) Mfg. Lot L7E0761, Exp. 12/12/08;
31) Mfg. Lot 20029, Exp. 12/18/08;
32) Mfg. Lot 13817060, Exp. 12/06/08;
33) Mfg. Lot 07050701, Exp. 12/13/08;
34) Mfg. Lot C71353, Exp. 12/19/08;
35) Mfg. Lot B0159, Exp. 12/06/08;
36) Mfg. Lot 0957, Exp. 12/13/08;
37) Mfg. Lot 162383A, Exp. 12/20/08;
38) Mfg. Lot 59623D, Exp. 12/09/08;
39) Mfg. Lot C070910, Exp. 12/10/08;
40) Mfg. Lot 7G61, Exp. 07/01/09;
41) Mfg. Lot C061262, Exp. 12/01/08
42) Mfg. Lot 07091201, Exp. 12/17/08;
43) Mfg. Lot F0308, Exp. 12/25/08;
44) Mfg. Lot 169358, Exp. 12/10/08;
45) Mfg. Lot 650069, Exp. 05/01/09;
46) Mfg. Lot 7ZP8339, Exp. 12/17/08;
47) Mfg. Lot 07072601, Exp. 08/01/09;
48) Mfg. Lot 137171F, Exp. 01/01/09;
49) Mfg. Lot 10037496, Exp. 03/01/10;
50) Mfg. Lot 99492, Exp. 02/01/10;
51) Mfg. Lot AD32TA, Exp. 01/01/09;
52) Mfg. Lot 7FE0738, Exp. 11/01/10;
53) Mfg. Lot 016407004, Exp. 04/01/11;
54) Mfg. Lot 53917AA21, Exp. 06/01/09;
55) Mfg. Lot GC7035, Exp. 03/01/10;
56) Mfg. Lot N57291, Exp. 03/01/09;
57) Mfg. Lot MN07076, Exp. 08/01/09
RECALLING FIRM/MANUFACTURER
Advantage Dose LLC, Shreveport, LA,
REASON Non-conformance with current Good Manufacturing Practices.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION AR, GA, IL, LA, MS, MO, OK, TX

PRODUCT 
1) Klonopin Wafers (clonazepam orally disintegrating tablets) 0.25 mg, 60 Tablets (10 x 6), Rx only, NDC 0004-0280-07 Made in Switzerland. 

2) Klonopin Wafers (clonazepam orally disintegrating tablets) 0.5 mg, 60 Tablets (10 x 6), Rx only, NDC 0004-02810-22, Made in Switzerland. 

3) Klonopin Wafers (clonazepam orally disintegrating tablets) 1 mg, 60 Tablets (10 x 6), Rx only, NDC 0004-0282-22, Made in Switzerland. 

4) Klonopin Wafers (clonazepam orally disintegrating tablets), 0.125 mg, 60 Tablets (10 x 6), Rx only, NDC 0004-0279-22, Made in Switzerland. 
CODE
1) Lot numbers: U2039-50, Exp. 9/2009; U2040-50, Exp 9/2009; U2041, Exp. 9/2009; U2041-01, Exp 9/2009; U2042, Exp 9/2011;
2) Lot U3039, Exp. 3/2011;
3) Lot U4017, Exp. 3/2011;   
4) Lot U1011, Exp. 2/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hoffmann La Roche Inc, Nutley, NJ,
Manufacturer: Cardinal Health, Swindon, United Kingdom. 
REASON Subpotent
VOLUME OF PRODUCT IN COMMERCE
36,982
DISTRIBUTION Nationwide

PRODUCT  Meijer brand Children’s Ibuprofen oral suspension, Berry Flavor, 100 mg/5 ml., 4 fl. oz; NDC 41250-685-26. 
CODE Lots 8GK0243, 8KK0450, 8LK0475, 8LV0863, 9BK0458, 9CK0033 and 9CK0579
RECALLING FIRM/MANUFACTURER
L. Perrigo Co, Allegan, MI,
REASON Labeling illegible; the allergy alert warnings on the label are missing letters. Warning should read: Symptoms may include hives, facial swelling, asthma/wheezing, shock, skin reddening, rash and blisters.
VOLUME OF PRODUCT IN COMMERCE
9,024 bottles
DISTRIBUTION IL, IN KY, MI, OH

Teva Pharmaceuticals USA issues a nationwide recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B 

Teva Pharmaceuticals USA is recalling  Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers.

Customers who have Propofol lots 31305429B and 31305430B in their possession are instructed to cease using the product and return it to their distributor.  

Consumers with questions may contact 1-866-262-1243 from 8:00 am – 8:00 pm EDT Monday – Friday.

Haloteco Issues A Nationwide Recall of Libipower Plus, a Product Marketed as a Dietary Supplement 

Haloteco is recalling the company's product sold under the name Libipower Plus.

Haloteco is conducting this recall after lab analysis of Libipower Plus samples found that the product contained Tadalalafil which is the active ingredient of FDA approved drugs for Erectile Dysfunction (ED). The product label doesn’t states it contain tadalafil. The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing. 

Libipower Plus is sold as a 1 capsule blister pack through distributors and retail stores in California.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. 

Consumers with questions may contact Haloteco Monday through Friday 8:00 am to 5:00 pm at (213) 820-9523. 

Nature & Health Co. Issues Nationwide Recall of Six Male Enhancement Products Marketed as Dietary Supplements 

Opteron 1 Inc. dba Nature & Health Co.,  is conducting a nationwide recall of the company's five supplement products sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac.

The Company has been informed that lab analysis of these five samples found they contains either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED) , its analog aminotadalafil, or the analog of sidenafil, an active ingredient of another FDA-approved ED drug, making these products unapproved drugs. None of the active drug ingredients are listed on the product labels.  The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing. 

The six recalled products listed below were distributed in retail stores in California, Georgia, Illinois, Texas, and Ohio.

Customers who have these products in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Consumers should return any unused products, for a refund of the full purchase price or price for the unused portion, to the retail location where they were purchased or contact Nature & Health directly at (714) 671-0016Monday – Friday, 8am to 5pm or by email at sales@naturenhealth.com to receive further instructions for returning the product or with any questions.

Young You Corporation Issues a Nationwide Recall of Weight Loss Pills 

Young You Corporation has been informed that four weight loss dietary supplements sold and marketed by the firm contain an undeclared drug ingredient.  All lots of the following dietary supplement products are being recalled:

The products listed above were sold and distributed nationwide via the internet and at the company’s Weight Loss and Rejuvenation Center in Tarzana. 

Consumers are advised to destroy the above products or return them to the company’s address in Tarzana, CA. 

Consumers with questions may contact Young You Corp Monday through Friday 9:00 am to 5:30 pm at 818-344-3344.  

Brookstone Pharmaceuticals Issues a Recall of All Lots of Brookstone Pharmaceuticals' Concentrated Acetaminophen Drops 

Brookstone Pharmaceuticals, LLC, Alpharetta, GA has initiated a nationwide recall of all lots of Concentrated Acetaminophen Drops (NDC#42192-504-16) in 16 ounce (473 ml) bulk containers.  This 16oz container is comparable to the size generally used to package regular strength acetaminophen liquid preparations. This aspect of the product coupled with the absence of an integrated dosage delivery device is a contributing factor to possible dosing errors, especially inadvertent overdosing. Brookstone has distributed 344 bottles nationally and has donated 5301 bottles to charity for international distribution.

Brookstone’s concentrated acetaminophen contains acetaminophen 80 mg/0.8 mL.  Regular strength acetaminophen elixir contains 160 mg/5 ml.  The firm is recalling its product to the consumer level as a cautionary measure to minimize any confusion and potential risk to patients from dosing errors.

Brookstone Pharmaceuticals has notified customers that it has voluntarily stopped manufacturing and shipping Concentrated Acetaminophen Drops in bulk containers and has also advised customers (wholesalers and hospitals) to quarantine and hold the product for return to Brookstone Pharmaceuticals for a full refund.  

Customers with questions about the recall may contact Brookstone Pharmaceuticals, LLC at 1-800-541-4802, option 2.  

The recalled drops were manufactured by Pharmaceutical Associates, Inc.  

WEEK ENDING JULY 11

PRODUCT 
1) Dextroamphetamine Sulfate Tablets, USP, CII, 10 mg, packaged in 100 tablet bottles, 12 bottles/case, Rx only, NDC 58177-312-04. 

2) Isosorbide Mononitrate Extended-Release Tablets, 30 mg, packaged in 100 tablet bottles, 12/case, Rx only, NDC 58177-222-04. 

3) Isosorbide Mononitrate Extended-Release Tablets, 60 mg, packaged in 100 and 500 tablet bottles, 12/case, Rx only, NDC 58177-238-04 (100 tab), and NDC 58177-238-08 (500 tab). 

4) Morphine Sulfate Extended-release Tablets, CII, 15 mg, packaged in 100 tablet bottles, 12/case, Rx only, NDC 58177-310-04. 

5) Morphine Sulfate Immediate-Release Oral Tablets, CII, 15 mg, packaged in 100 tablet bottles, Rx only, NDC 58177-313-04. 

6) Morphine Sulfate Immediate-Release Oral Tablets, CII, 30 mg, packaged in 100 tablet bottles, Rx only, NDC 58177-314-04. 

7) Propafenone HCl Tablets, 150 mg, packaged in 100 tablet bottles (NDC 58177-331-04), and 10 x 10 unit dose packs (NDC 58177-331-11), all packed 12/case, Rx only. ;

8) Propafenone HCl Tablets, 225 mg, packaged in 100 tablet bottles, 12/case, Rx only, NDC 58177-332-04. 

9) Propafenone HCl Tablets, 300 mg, packaged in 100 tablet bottles, 12/case, Rx only, NDC 58177-333-04. 
CODE
1) Lot numbers 73934, 75892, 77945, 81137, and 86320, expiration dates 6/2009-5/2011;

2) Lot numbers 62355, 66423, and 68102, expiration dates 11/2008-8/2009;

3) Lot numbers 63466, 66034, 67351, and 67354, expiration dates 12/2008-11/2009;

4) Lot numbers 81175, 82514, 82515, 82516, 89660, 89664, 89667, 90249, 90250, 90251, and 91687, expiration dates 12/2008-2/2010;

5) Lot numbers 77852, 77853, 77854, 81746, 82519, 82520, 84113, 90276, 90277, 90278, expiration dates 9/2009-1/2011;

6) Lot numbers 75093, 77855, 77856, 77857, 82297, 82521, 82522, 87239, 88925, 90288, 90289, 90290, 90291, 90292, 90293, 90294, 90295, 90296, 90297, and 90298, expiration dates 8/2009-3/2011;

7) Lot numbers 73761, 78184, 79373, 81241, 81242, 83470, 84357, 90525, 90526, and 81240 (unit dose only), expiration dates 3/2009-3/2011;

8) Lot numbers 71720, 74831, 76014, 76015, 81243, 81244, 81245, 89731, 90527, 90528, 90529, and 90657, expiration dates 3/2009-2/2011;

9) Lot numbers 72834, 76016, 76017, 76018, 81246, 89092, 89732, 90530, 90532, 91641, 91642, expiration dates 6/2009-3/2011;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethex Corporation, Bridgeton, MO, 
Manufacturer: KV Pharmaceutical Co Westport, Saint Louis, MO.
REASON The products may contain oversized tablets.
VOLUME OF PRODUCT IN COMMERCE
5,694.360 bottles (The volume is a total of all products recalled by Ethex in this Enforcement Report)
DISTRIBUTION Nationwide

PRODUCT 
1) Dantrolene Na, 100mg CAP, Mfg. GLD, NDC 00115-1166-01.

2) Dilantin Extended, phenytoin, 30MG CAP, Mfg. PFZ, NDC 00071-0365-24. 

3) Inspra, Eplerenone, 50MG TAB, Mfg. PFZ, MDC 00025-1720-03. 
 
4) Niacin ER, 500MG CAP, Mfg RUG, NDC 00536-4077-01. 
 
5) Carvedilol, sub: Coreg, 25MG TAB. Mfg. A-C, NDC 60505-2609-08. 
 
6) Lescol XL, fluvastatin sodium 80MG E-R TAB, Mfg. NVT, NDC 00078-0354-05. 
 
7) Paroxetine HCl, 10MG TAB, Mfg. PAR, NDC 49884-0876-11. 
 
8) Acetaminophen, 325 TAB, Mfg. RUG, NDC 00536-3222-01. 
 
9) Glucosoamine with Chondroitin TAB, Mfg. N-B, NDC 74312-0049-62. ;
 
10) Methylprednisolone, 4MG TAB, Mfg. SNZ, Adv Dose.  
 
11) Aspirin EC, 81MG, DR TAB, Mfg. IVX, NDC 00182-1062-07. 
 
12) Ferrous Sulfate, 325MG (5GR) TAB, Mfg. QLT. 
 
13) Tasmar, tolcapone, 100MG TAB. Mfg. ICN. 

14) Diclofenac Potassium, sub: Cataflam, 50MG, TAB, Mfg. SNZ, NDC 00781-5017-01. 
 
15) Naproxen EC, Delayed-Release, 500MG TAB, Mfg. Lot E0024E1, Exp. 08/07/09, Mfg. ETH, NDC 58177-0303-04. 
 
16) Slow Fe TAB, Ferrous Sulf (Iron), 160mg (47.5MG), Mfg. NVT. 
 
17) Nitrofurantoin Mono, sub: Macrobid, 100MG CAP, Mfg. MYL, NDC 00378-3422-01. 

18) Benzonatate, 100MG CAP, Mfg. PPI, NDC 20091-0536-01. 
 
19) Xeloda, capecitabine, 500MG TAB, Mfg. ROC, NDC 00004-1101-50. 
 
20) Rimantadine HCl, 100MG TAB, Mfg. INU, NDC 00258-3711-01. 
 
21) Valproate Sodium, 500MG/5ML SDV, 5ML, Mfg. BED. NDC 55390-0007-10. 
 
22) Oyst-Cal-Dal, Calcium Carb+D, 500MG/200IU TAB, Mfg. IVX. 

23) Symbyax, olanzapine/fluoxetine, 12/25 CAP, Mfg. LIL, NDC 0002-3232-30. 
 
24) Estropipate, sub: Ogen, 1.5MG TAB, Mfg. BAR, NDC 00555-0728-02. 
 
25) Glucopyrrolate, sub: Robinul Forte 2MG TAB, Mfg. RIS, NDC 64980-0132-01. 
 
26) Ery-Tab, Erythromycin Base DR, 333MG EC TAB, Mfg. ABB, NDC 00074-6320-13.  
 
27) Magnesium Sulfate, 50%, 1GM/2ML Vial, 2ML. Mfg. A-R, NDC 00517-2602-25. 
 
28) Antabuse, Disulfiram, 250MG TAB, Mfg. DMD, NDC 51285-0523-02. 
 
29) Dexamethasone, sub: Decatron, 1MG TAB, Mfg. ROX, NDC 00054-4181-25. 
 
30) Nitroglycerin, Extended-Release, 2.5MG CAP, Mfg. TCL, NDC 00603-4782-21.  
 
31) Hydroxyzine HCL, 50MG TAB, Mfg. PLV, NDC 50111-0309-01. 
 
32) Occuvite Lutein, Vit C, E, /Lutein+Min, CAP, Mfg. B&L, NDC 24208-0403-19. 
 
33) Promethazine, 12.5MG, Suppository, Mfg. PAD. 
 
34) Creon 10, Pancrelipase D-R, CAP Mfg. SLV, NDC 00032-1210-07. 
 
 35) Thiothixene, 1MG CAP, Mfg. MYL, NDC 0078-1001-01. 
 
36) Tramadol HCl, 50MG TAB, Mfg. AKY, NDC 65162-0627-11. 
 
37) Simvastatin, 80MG TAB, Mfg. RED, NDC 55111-0268-90. 

38) Simvastatin, 10MG TAB, Mfg. RED, NDC 55111-0198-90. 
 
39) Furosemide, 20MG TAB, Mfg. QLT, NDC 00603-3739-32. 
 
40) Belladonna Alka/PB, sub: Donnatal (16.2MG PB) TAB, Mfg. QLT, NDC 00603-2418-21. 
 
41) Moexipril HCl, 15MG TAB, Mfg. PAC, NDC 00574-0112-15. 
 
42) Truvada, Emtricitab/Tenofovir, 200/300MG TAB, Mfg. GSI, NDC 61958-0701-01. 
 
43) Desmopressin, 0.1MG TAB, Mfg. BAR. 
 
44) Nicotine Polacrilex, 2MG Gum, Mfg. RUG. 

45) Folgard TAB, Vit B6, B12, FA, 10/0.115/0.8MG, Mfg. PAD, NDC 00245-0017-60.   
 
46) Niacin, 500MG TAB, Mfg. MAJ, NDC 00904-2272-60. 
 
47) Finasteride, 5MG TAB, Mfg. RED. 
 
48) Bisac-Evac, Bisacodyl, 10MG Suppository, Mfg. G&W. 
 
49) Benazepril/HCTZ, sub: Lotensin/HCTZ, 20/12.5MG TAB, Mfg. SDZ, NDC 00185-0122-01. 
 
50) Natalcare Plus, TAB, Mfg. ETH, NDC 58177-0225-04, 
 
51) Ketoconazole, 200MG TAB, Mfg. TEV. 
 
52) Requip, Ropinirole, 0.5MG TAB, Mfg. GSK, MDC 00007-4891-20. 

53) Midodrine HCl, 5MG TAB, Mfg. Myl, NDC 00378-1902-01. 

54) Folic Acid/B6/B12, Sub: Foltx Tablet, 2.5/25/1MG TAB, Mfg. MLT, NDC 00045-0515-10. 

55) Divalproex Sod, Delayed-Release, 500MG TAB, Mfg. LUP, NDC 38180-0267-02. 
 
56) Coumadin, Warfarin, Sodium, 4MG TAB, Mfg. BRI. 
 
57) Aleve, 220MG CPL, Mfg. BAY, NDC 32586-6105-06. 
 
58) Topamax, Topiramate, 50MG TAB, Mfg. JOM, NDC 0045-0640-65. 
 
59) Pink Bismuth, Bismuth Subsalicylate, 262MG/15ML SUSP, 30ML, Mfg. GDL, NDC 00182-1811-44. ;
 
60) Didanosine DR, 200MG CAP, Mfg. BAR. 

61) Lotrel, 5/20, Amlodipine/Benazepril, 5/20MG CAP, Mfg. NVT, NDC 00078-0406-05. 
 
62) Zerit, Stavudine, 40MG CAP, Mfg. BRI, NDC 00003-1967-01. 
 
63) Detrol LA, Tolerodine ER, 4MG CAP, Mfg. PFZ. 
 
64) Avalide, Irbesartan/HCTZ, 150/12.5MG TAB, Mfg. BRI, NDC 00087-2775-32. 
 
65) Ethamolin, 5% AMP, 2ML, Mfg. OOL, NDC 67871-4790-06.
 
66) Sorbitol, 70% Solution, 5ML. Mfg. PMA, NDC 00121-0659-16. 

67) Dexamethasone, Sugar and Dye Free, 0.5MG/5ML SOL, 5ML, Mfg. ROX, NDC 00054-3177-63. 
 
68) Isuprel, Isoprorerenol HCL, 0.2MG/ML AMP, 5ML, Mfg. HOS, NDC 00409-1410-05. 
 
69) Diltiazem HCL ER, Extended Release, 120MG CAP, Mfg. INW, NDC 002583687-90. 
 
70) Calcitriol, 1MCG/ML AMP, 1ML, Mfg. APP, NDC 63323-0731-01. 
 
71) Magonate, Magnesium gluconate, 1G/5ML LIQ, 5ML, Mfg. FLE, NDC 00256-0184-07. 
 
72) Simple Syrup NF, Sucrose, 85% SYPRP, Mfg. HUM, NDC 30395-2661-19. 
 
73) Diltiazem HCL ER, Extended Release, 18MG CAP, Mfg. INW, NDC 00258-3688-90. 
 
74) Dehydrated Alcohol, 98% AMP, 1ML, Mfg. A-R, NDC 00517-8571-10. 
 
75) Diltiazem HCL ER, Extended Release, 360MG CAP, Mfg. INW, NDC 00259-3691-90. 
 
76) Avelox, Moxifloxacin HCL, 400MG TAB, Mfg. BAY, NDC 00085-1733-01. 
 
77) OS-CAL+D, Calcium Carb+Vit D, 500MG/200IU TAB, Mfg. GSK, NDC 30766-1654-60. 
 
78) Trichophyton Vial, 2ML, Mfg. ALK. 
 
79) Metoprolol SUC ER, sub: Toprol XL, 200MG TAB. Mfg. ETH, NDC 58177-0358-04. 
 
80) Captopril/HCTZ, sub: Capozide, 25/15MG TAB, Mfg. Lot 27627, Exp 05/01/09, Mfg. TEV, NDC 51285-0444-02. ;
 
81) Cilostazol, 50MG TAB, Mfg. OPC, NDC 66993-00008-60. 
 
82) Stalevo, 150 TAB, Carbid/L-Dopa/Entac, 37.5/150/200MG, Mfg. Lot F4128, Exp. 09/12/09, Mfg. NVT, NDC 00078-0409-05. 

83) Amantadine HCL, 50MG/5ML SUR, QTY 5ML, Mfg. HTP, NDC 50383-0807-16. 
 
84) Cenestin, Estogens. Conj., Syn A, 1.25MG TAB, Mfg. DMD, NDC 51285-0444-02. 
 
85) Ursodiol, 300MG CAP, Mfg. WAT. 
 
86) Pravastatin Sod, sub: Pravachol, 10MG TAB, Mfg. A-C, NDC 60505-0168-09. 
 
87) Prandin, Repaglinide, 2MG TAB, Mfg. NPH. 

88) Lithium, 8MEQ/5ML, SOL, Qty 5ML, Mfg: ROX, NDC 00054-3527-63. 
 
89) Claritin Allergy, Child, Loratadine, 5MG/5ML SOL, 5ML, Mfg. SPH, NDC 11523-7163-01. 

90) Hyoscyamine Sulf, sub: Levsin, 0.125-5ML ELIX, 5ML, Mfg. QLT, NDC 00603-1315-58. 

91) Vitamin B-12, Cyanocobalamin, 100MCG TAB, Mfg. NVC, NDC 79054-0200-50. 
 
92) Klor-Con, Potassium Chloride, 20MEQ Pack, Mfg. UPS. 
 
93) Bentyl Inj, dicyclomine, 10MG/ML AMP, 2ML, Mfg. S/I, NDC 58914-0080-52. 
 
94) Digoxin, 0.125MG (125MCG) TAB, Mfg Lot 016808, Exp. 09/25/09, Mfg. LAN, NDC 00527-1324-01. 
 
95) Ethamolin, Ethanolamine Oleate, 5% AMP, Nfg QOL. 
 
96) Naproxen Sod ER, sub: Naprelan, 500MG TAB, Mfg. WAT, NDC 62037-0826-75. 
 
97) Chlorhexidine Gluc, Oral Rinse, 0.12%, Mfg. HTP, NDC 50383-0720-16. 
 
98) Venlafaxine HCl, sub: Effexor, 75MG TAB, Mfg. RED, NDC 5511-0548-90. 
 
99) Metoprolol ER, sub: Toprol XL, 25MG TAB, Mfg. SDZ, NDC 00185-0201-01. 
 
100) Pravastatin Sod, 10MG TAB, Mfg. Lot C82685, Exp.09/25/09, Mfg. RED. 
 
101) Imipramine, sub: Tofranil, 10MG TAB, Mfg. SDZ, NDC 00781-1762-01. 
 
102) Mag-SR, Magnesium SF, 64MG TAB, Mfg. CYP, NDC 60258-0173-06. 

103) Solu-Cortef, Hydrocort Sod Suc, 250Mg/ML, Vial, 2ML, Mfg. PFZ. ;
 
104) Allegra-D, 12 Hour, Fexofen/Pseudo E-R, 60MG/120MG TAB, Mfg. S-A, NDC 00088-1090-47. 
 
105) Baclofen, 20MG TAB, Mfg. IVX, NDC 00172-4097-60. 
 
106) Acetaminophen, Suppository, 650MG, Mfg. Lot 80T0057, Exp 04/01/11, Mfg. GDL, 
 
107) Cardizem LA, Diltiazem HCL ER, 120MG TAB, Mfg. Lot 08F066P, Exp. 09/25/09, Mfg. ABB, NDC 00074-3045-30. 
 
108) Vesanoid, (Tretinoin), 10MG CAP, Mfg. ROC, NDC 00004-0250-01. 

109) E.E.S. 400, E-Mycin Ethsucc, 400MG TAB, Mfg ABB, NDC 00074-5729-13. 
 
110) Acetaminophen Pediatric Suppository, 1220MG, Mfg. GDL. 
 
111) Coreg CR, Carvedilol E-R, 20MG CAP, NDC 0007-3371-13. 
 
112) ICAR-C, Carbonyl Iron/Vit C, 100/250MG TAB, Mfg. HAW, NDC 63717-0099-01. 
 
113) Mestinon TAB, Pyridostigmine BR, 60MG TAB, Mfg. ICN, NDC 00187-3010-30. 
 
114) Viokase 8, Pancrelipase, TAB, Mfg. SI, NDC 58914-0111-10. 
 
115) Aceon, Perindopril ERB, 4MG TAB, Mfg. SLV, NDC 00032-7591-60. 
 
116) Ferrous Sulf, 325MG TABLET, Mfg. MAJ, NDC 00904-7591-60. 
 
117) Metformin HCl, Extended-Release, 500MG ER TAB, Mfg. A-C, NDC 60505-0260-01. 
 
118) Allopurinol Sodium, for IV Infusion, 500MG Vial, Mfg. BED. ;
 
119) Sulindac, sub: Clinoril, 150MG TAB, Mfg. WAT, NDC 00591-5661-01. 
 
120) Torsemide, 100MG TAB, Mfg. Lot HW5683, Exp. 09/18/09, Mfg. A-C. ;
 
121) Utira-C, TAB, Mfg. HAW, NDC 63717-0513-01.  
 
122) Ery-Tab, Erythromycin EC, 250MG TAB, Mfg. ABB, NDC 00074-6304-13. 
 
123) Lactase Enzyme, sub: Lactaid, CAPLET, Mfg. GDD, NDC 70030-0135-63. 
 
124) Fleet Pedia-Lax, Rectal Enema, 66ML, Mfg. CBF, 
 
125) Antivert, Meclizine HCl, 25MG TAB, Mfg. PFZ, NDC 00049-2110-66. 
 
126) Tarka, Trandolapril/Verap, 2/240MG TAB, Mfg. ABB, NDC 00074-3289-13. 
 
127) Megestrol Acetate, 400MG/10ML Susp, 10ML, Mfg. PAR, NDC 49884-0907-61. 
 
128) Pilocarpine Ophthalmic Solution, 1% Drop, 15ML, Mfg. FAL. 
 
129) Anu-Med, Phenylephrine, 0.25% Suppository, Mfg. MAJ. ;
 
130) Hydroxyzine HCl, 10MG/5ML Syrup, 5ML. Mfg. MGP, NDC 60432-0150-16. 
 
131) Lactocal-F, Prenatal Multivit/Min TAB, Mfg. LAS, NDC 00277-0179-01. 
 
132) Prednisolone, 15MG/5ML Syrup, 5ML, Mfg. ETH, NDC 58177-0910-05. 
 
133) Naproxen Sod, 275MG TAB, Mfg. TEVA, NDC 00093-0536-01. 

134) Phenytoin, Oral Suspension, 125MG/5ML, 5ML. Mfg. APH, NDC 00472-0067-08. 
 
135) Acebutolol, sub: Sectral, 400MG CAP, Mfg. MYL, NDC 00378-1400-01. 
 
136) Thera-M, TAB, Mfg. Lot 27643, Exp. 09/22/09, Mfg. PLU, NDC 51645-0875-13. 
 
137) Entocort EC, Budesonide, 3MG CAP, Mfg. P/L, NDC 65483-0702-10. 
 
138) Vitamin B-6, Pyridoxine, 100MG TAB, Mfg. MAJ, NDC 00904-0518-60. 
 
139) Metoprolol Succinate Extended-Release, 25MG TAB, Mfg. PAR, NDC 19884-0404-01. 

140) Guaifensin, 100MG Pack, Mfg. ADA. 
 
141) Phenazopyridine HCl, 100MG TAB, Mfg. QLT, NDC 00603-5141-21. 
 
142) Symbyax, Olanzapine/Fluoxetine, 6MG/25MG CAP, Mfg. LIL, NDC 00002-3231-30. 
 
143) Coumadin, Warfarin Sodium, 10MG TAB, Mfg. BRI. 

144) Minoxidil, 10MG TAB, Mfg. PAR, NDC 49884-0257-01. 
 
145) Vitamin E, Softgel, 1000 IUNITS, Mfg. GDL NDC 00182-0083-01. 
 
146) Prezista, Darunavir Ethanolate, 300MG TAB, Mfg. JOM. ; 
 
147) Prednisolone, 15MG/5ML Syrup, 5ML. Mfg. ETH, NDC 58177-0910-07. 
 
148) Renagel, Sevelamer HCl, 400MG TAB, Mfg. G/C, NDC 58468-0020-01. 
 
149) Phenazopyridine HCl, 200MG TAB, Mfg. QLT, NDC 00603-5142-21. 
 
150) Selzentry, Maraviroc, 300MG TAB, Mfg. PFZ. 

151) Theophylline ER, Extended-Release, 200MG TAB, Mfg. INW, NDC 00258-3583-01. 
 
152) Norethindrone, sub: Aygestin, 5MG TAB, Mfg. BAR, NDC 0055-0211-10. 

153) Vitamin B-1, Thiamin, 100MG, Mfg. N-B, NDC 75412-0016-70. 
 
154) Prezista, Darunavir Ethanolate, 600MG TAB, Mfg. JOM. 

155) Torsemide, 20MG TAB, Mfg. TEV, NDC00093-7129-01. ;
 
156) Indomethacin ER, 75MG CAP, Mfg. SNZ, NDC 00185-0720-01. 
 
157) Lanoxin, Digoxin Tab, 0.125MG (125MCG), NDC 00173-0242-55. 
 
158) Senna-Gen, 8.6MG TAB, Mfg. MAJ. 
 
159) Acetazolamide, 250MG TAB, Mfg. LAN, NDC 00527-1050-01. 
 
160) Therapeutic Tablets, Multivitamins, TAB, Mfg. GDL, NDC 00182-4518-06. 
 
161) Niacin, Timed-Release, 500mg TAB, Mfg. GDL, 
 
162) Trimethoprim, 100MG TAB, Mfg. WAT, NDC 00591-5571-01. 
 
163) Amitriptyline, 10MG TAB, Mfg. SNZ, NDC 00781-1486-01. 
 
164) Buprion XL, 300MG TAB, Buprion XL, Mfg. ANC, NDC 10370-0102-03. 
 
165) Mycobutin, Rifabutin, 150MG CAP, Mfg. PFZ. Recall # D-1094-2009;
 
166) Isordil, Isosorbide Dinitrate, 40MG TAB, Mfg. MED, NDC 64455-0192-01. 
 
167) Rythmol SR, Propafenone ER, 225MG CAP, Mfg. REL, NDC 65726-0261-15. 

168) Etodolac, 500MG TAB, Mfg. SDZ, NDC 00185-0139-01. 

169) Detrol, Tolterodine Tartrate, 1MG TABLET, Mfg. PFZ, NDC 00009-4511-02. 
 
170) Estropipate, sub: Ogen, 0.75MG TAB, Mfg. MYL, NDC00378-4551-01.
CODE
1) Mfg. Lot 8022021, Exp. 08/14/09;
2) Mfg. Lot 906N7L, Exp. 08/12/09;
3) Mfg. Lot C080203, Exp. 8/12/09;
4) Mfg. Lot A068U, Exp 08/13/09;
5) Mfg. Lot HR7493, Exp. 08/14/09;
6) Mfg. Lot F4290, Exp. 08/12/09;
7) Mfg. Lot 46276, Exp. 08/01/09;
8) Mfg. Lot 08D199, Exp 08/13/09;
9) Mfg. Lot 13928303, Exp. 08/14/09;
10) Mfg. Lot 170413, Exp. 08/12/09;
11) Mfg. Lot 89D028U, Exp. 08/12/09;
12) Mfg. Lot 08F324, Exp. 06/01/10;
13) Mfg. Lot U002750B, Exp. 08/15/09;
14) Mfg. Lot 171936, Exp. 08/05/09;
15) Mfg. Lot E0024E1, Exp. 08/07/09;
16) Mfg. Lot 10046051, Exp. 09/01/10;
17) Mfg. Lot 3002805, Exp. 08/11/09;
18) Mfg. Lot 5367028A, Exp. 08/06/09;
19) Mfg. Lot U9112, Exp. 08/08/09;
20) Mfg. Lot 16125, Exp. 08/08/09;
21) Mfg Lot 1359795, Exp. 06/01/10;
22) Mfg. Lot 874507412, Exp. 08/07/09;
23) Lot A495558, Exp. 08/06/09;
24) Mfg. Lot 304642, Exp.08/07/09;
25) Mfg. Lot CPL7119, Exp. 08/08/09;
26) Mfg Lot 6188AF21, Exp. 08/11/09;
27) Mfg. Lot 8485, Exp 07/01/10;
28) Mfg. Lot 7067006A, Exp 08/07/09;
29) Mfg. Lot 758157A, Exp. 08/08/09;
30) Mfg. Lot A067U, Exp. 08/11/09;
31) Mfg. Lot 306879, Exp. 08/11/09;
32) Mfg. Lot 116681774A, Exp. 08/07/09;
33) Mfg. Lot 8152698, Exp. 03/01/10;
34) Mfg. Lot 500100, Exp. 02/11/09;
35) Mfg. Lot 3003091, Exp. 08/11/09;
36) Mfg. Lot 6278217A, Exp. 02/04/09;
37) Mfg. Lot C81515, Exp. 08/05/09;
38) Mfg. Lot C80425, Exp. 08/05/09;
39) Mfg. Lot T141R08A, Exp. 12/21/08;
40) Mfg. Lot T113D08A, Exp 09/19/09;
41) Mfg. Lot 8263382, Exp. 09/22/09;
42) Mfg. Lot C373881D, Exp. 09/22/09;
43) Mfg. Lot 701117, Exp 09/23/09;
44) Lot ZNK07110, Exp 10/01/09;
45) Mfg. Lot J08C207, Exp. 09/22/09;
46) Mfg. Lot 17583305, Exp. 09/22/09;
47) Mfg. Lot C80715, Exp 09/23/09;
48) Mfg. Lot 010908006, Exp. 04/01/11;
49) Mfg. Lot 174885, Exp. 09/22/09;
50) Mfg. Lot 96430, Exp. 09/22/09;
51) Mfg. Lot 29635, Exp. 09/23/09;
52) Mfg. Lot X8286A, Exp 09/22/09;
53) Mfg. Lot 3002364, Exp 09/22/09;
54) Mfg. Lot 3255084, Exp. 09/22/09;
55) Mfg. Lot 3801581, Exp 09/23/09;
56) Mfg. Lot 9836842B, Exp 09/23/09;
57) Mfg. Lot 264348C, Exp 09/22/09;
58) Mfg. Lot 8HG833, Ex 09/22/09;
59) Mfg. Lot W078, Exp. 09/22/09;
60) Mfg. Lot 307019, Exp. 09/23/09;
61) Mfg. Lot F0522, Exp. 09/22/09;
62) Mfg. Lot 7J3035A, Exp. 09/22/09;
63) Mfg. Lot C080279, Exp. 09/01/09;
64) Mfg. Lot 8F2029A, Exp. 09/11/09;
65) Mfg. Lot 1114857, Exp. 10/01/09;
66) Mfg. Lot 8G02, Exp. 09/12/09; 
67) Mfg. Lot 856711A, Exp 09/12/09; 
68) Mfg. Lot A28743, Exp. 04/01/09;
69) Mfg. Lot P071111, Exp. 09/11/09;
70) Mfg. Lot A28743, Exp 06/01/09;
71) Mfg. Lot 0801796, Exp. 09/12/09;
72) Mfg. Lot 528476, Exp 09/12/09;
73) Mfg. Lot P0801, Exp. 09/11/09:
74) Mfg. Lot 8361, Exp. 05/10/10;
75) Mfg. Lot P080205, Exp. 09/11/09;
76) Mfg. Lot 54013N4, Exp. 09/12/09;
77) Mfg. Lot 7K05, Exp. 09/12/09;
78) Mfg. Lot 8A00491, Exp. 01/08/10;
79) Mfg. Lot 96466, Exp. 09/12/09;
80) Mfg. Lot 27627, Exp 05/01/09;
81) Mfg. Lot 7G82CBT1P, Exp 09/11/09;
82) Mfg. Lot F4128, Exp. 09/12/09;
83) Mfg. Lot 803807, Exp 09/12/09;
84) Mfg. Lot 306496, Exp 09/12/09;
85) Mfg. Lot 97673A, Exp. 09/11/09;
86) Mfg. Lot HT8275, Exp. 09/12/09;
87) Mfg. Lot 706647C, Exp. 09/11/09;
88) Mfg. Lot 757791C, Exp. 09/12/09;
89) Mfg. Lot 8LTN6, Exp. 09/15/09;
90) Mfg. Lot 5293A, Exp. 09/25/09;
91) Mfg. Lot 7BD17, Exp. 09/25/09;
92) Mfg. Lot 255436, Exp. 07/01/11;
93) Mfg. Lot 3064004, Exp 01/01/13;
94) Mfg Lot 016808, Exp. 09/25/09;
95) Mfg. Lot 1114857, Exp 10/01/09;
96) Mfg. Lot 81073A, Exp. 07/01/09;
97) Mfg. Lot 839720, Exp 09/25/09;
98) Mfg. Lot C81328, Exp. 09/25/09;
99) Mfg. Lot 179659, Exp. 09/26/09;
100) Mfg. Lot C82685, Exp.09/25/09;
101) Mfg. Lot 171084, Exp. 09/24/09;
102) Mfg. Lot B033U, Exp. 09/25/09;
103) Mfg. Lot 0ADMS, Exp. 05/01/12;
104) Mfg. Lot 1118482, Exp. 09/26/09;
105) Mfg. Lot BEK26A, Exp. 09/25/09;
106) Lot 80T0057, Exp 04/01/11;
107) Mfg. Lot 08F066P, Exp. 09/25/09;
108) Mfg. Lot V0021, Exp. 09/26/09;
109) Mfg. Lot 56983CG21, Exp 09/24/09;
110) Mfg. Lot 8CT0174, Exp 03/01/11;
111) Mfg. Lot X4597, Exp. 09/26/09;
112) Mfg. Lot 074239, Exp 09/25/09;
113) Mfg. Lot 8F4799, Exp. 9/25/09;
114) Mfg. Lot 112452AR, Exp. 09/17/09;
115) Mfg. Lot 3068214, Exp 09/17/09;
116) Mfg. Lot 081210, Exp. 09/17/09;
117) Mfg. Lot HX6185, Exp. 09/19/09;
118) Mfg. Lot 1208146, Exp. 04/01/10;
119) Mfg. Lot 94360A, Exp. 09/17/09;
120) Mfg. Lot HW5683, Exp. 09/18/09;
121) Lot 081386, Exp 09/19/09;
122) Mfg. Lot 669142E21, Exp. 09/17/09;
123) Mfg. Lot 8CV0639, Exp. 09/17/09;
124) Mfg. Lot 0816907, Exp. 06/01/11;
125) Mfg. Lot 80W001A, Exp. 09/19/09;
126) Mfg. Lot 669142E21, Exp 09/17/09;
127) Mfg. Lot 21516501, Exp. 09/17/09;
128) Mfg. Lot 129942F, Exp. 11/01/11;
129) Mfg. Lot SA31, Exp. 01/01/11;
130) Mfg. Lot 29515C, Exp. 09/19/09;
131) Mfg. Lot 323745, Exp. 09/17/09;
132) Mfg. Lot 94453, Exp. 09/17/09;
133) Lot 35300956A, Exp. 8/01/09;
134) Mfg. Lot R02469, Exp. 08/01/09;
135) Mfg. Lot 3004339, Exp. 09/07/09;
136) Mfg. Lot 27643, Exp. 09/22/09;
137) Mfg. Lot PJ0109, Exp. 09/07/09;
138) Mfg. Lot 18200408, Exp. 09/17/09;
139) Mfg. Lot PH0136, Exp. 09/19/09;
140) Mfg. Lot 0703943001, Exp. 07/01/09;
141) Mfg. Lot C0861007A, Exp. 09/15/09;
142) Mfg. Lot A508513A, Exp. 09/16/09;
143) Mfg. Lot EUJ394A, Exp. 09/01/09;
144) Mfg. Lot 20768601, Exp. 09/15/09;
145) Mfg. Lot 8736489604, Exp. 09/15/09;
146) Mfg. Lot 8GG615, Exp. 09/16/09;
147) Mfg. Lot 82640, Exp. 09/15/09;
148) Mfg. Lot B8033B01, Exp. 09/15/09;
149) Mfg. Lot C0301207A, Exp 09/15/09;
150) Mfg. Lot 0782048, Exp. 09/16/09;
151) Mfg Lot 6H009, Exp 09/15/09;
152) Mfg. Lot 307117, Exp. 09/15/09;
153) Mfg. Lot 23689102, Exp. 09/16/09;
154) Mfg. Lot 8DG616, Exp. 09/16/09;
155) Mfg. Lot T18082, Exp 09/15/09;
156) Mfg. Lot ML071965, Exp 09/16/09;
157) Mfg. Lot A38307, Exp. 09/16/09
158) Mfg. Lot D030U, Exp. 09/16/09;
159) Mfg. Lot 200-089986, Exp. 09/15/09;
160) Mfg. Lot 8715100510, Exp. 09/16/09;
161) Mfg. Lot 87236600202, Exp. 09/16/09;
162) Mfg. Lot 102026A, Exp 09/16/09;
163) Mfg. Lot 171387, Exp 09/15/09;
164) Mfg. Lot 2008043A, Exp. 09/16/09;
165) Mfg. Lot G481B, Exp. 09/16/09;
166) Mfg. Lot P08C052, Exp. 09/16/09;
167) Mfg. Lot 783246, Exp. 09/23/09;
168) Mfg. Lot ML080339, Exp. 09/24/09
169) Mfg. Lot C080019, Exp. 09/24/09;
170) Mfg. Lot 3S1435, Exp. 09/01/09
RECALLING FIRM/MANUFACTURER
Advantage Dose LLC, Shreveport, LA, .
REASON Not in conformance with cGMP
VOLUME OF PRODUCT IN COMMERCE
2,635,663 unit doses
DISTRIBUTION AR, GA, IL, LA, MS, MO, OK, and TX

PRODUCT 
1) Ry-Tann Tablets, Phenylephrine Tannate 25 mg/Chlorpheniramine Tannate 9 mg, 100 count bottles, Rx only. NDC 68308-822-10. 

2) D-Tann CT Tablets, Diphenhydramine Tannate 25 mg/Phenylephrine Tannate 10 mg/Carbetapentane Tannate 30 mg, 60 count bottles, Rx only. 

3) D-Tann CD Suspension, Diphenhydramine Tannate 25 mg/Phenylephrine Tannate 15 mg/Carbetapentane Tannate 30 mg, Antihistamine, Nasal Decongestant, Cough Suppressant, 4 fl. oz. container, Rx only, NDC 68308-140-04 UPC 3 68308 14004 1. 

4) D-Tann DM Suspension, Diphenhydramine Tannate 25 mg/Phenylephrine Tannate 7.5 mg/Dextromethorphan Tannate 75 mg, 4 oz. bottles, Cherry Flavor, Rx only. NDC 68308-138-04. 

5) B-Vex Suspension, Brompheniramine Tannate ,12 mg, 4 oz, Rx only, Banana Flavor, NDC 68308-922-04.

6) B-Vex D Suspension, Phenylephrine Tannate 20 mg/Brompheniramine Tannate 12 mg, 4 oz., Rx only, Bubblegum Flavor, Antihistamine, Decongestant, NDC 68308-926-04. 

7) Brom Tann 8mg/DM Tann 60 mg/ PSE Tann 90 mg Suspension, Brompheniramine Tannate/Dextromethorphan Tannate/Pseudoephedrine Tannate, 16 oz. Rx only, Antihistamine, Antitussive, Decongestant, NDC 10914-910-16. ;

8) DM Tann 30 mg/PE Tann 25 mg/ Brom Tann 10 mg Suspension, Dextromethorphan Tannate/Phenylephrine Tannate/Brompheniramine Tannate, 16 oz bottles, Rx only, NDC 10914-430-16. 

9) PE Tann 20 mg/CP Tann 4 mg Suspension, Phenylephrine Tannate/Chlorpheniramine Tannate, Nasal Decongestant/Antihistamine, 16 oz. bottles, Rx only, NDC 10914-420-16. ;

10) D-Tann Suspension, Diphenhydramine Tannate 25 mg/Phenylephrine Tannate 7.5 mg, 4 fl. oz., Rx only, NDC 68308-126004. ;

11) D-Tann CT Suspension, Diphenhydramine Tannate 25 mg/Phenylephrine Tannate 7.5 mg/Carbetapentane Tannate 30 mg, 4 fl. oz.., Antihistamine, Decongestant, Antitussive, Rx only, NDC 68308-130-04. 

12) Ben-Tann Suspension, Diphenhydramine Tannate 25 mg, Rx only, 4 fl. oz., NDC 68308-122-04. 

13) D-Tann AT Suspension, Diphenhydramine Tannate 25 mg/Carbetapentane Tannate 30 mg, Antihistamine, Antitussive, Rx only, 4 fl oz., NDC 68308-136-04. 
CODE
1) Batch number 806009, 806010, 806011; all exp. 5/2010;

2) Batch numbers 806003, Exp. 6/2010; 806004, Exp 5/2010;

3) Batch number L08F051, Exp date 05/2010;

4) Batch no. L08F121, L08F131; Exp 5/2010;

5) Batch No. L08D301, Exp. 3/2010; L08E021, Exp 4/2010; L08E051, Exp 4/2010;

6) Batch No. L08D031, L08D181, Exp 3/2010;

7) Batch number L08C181, L08C041;

8) Batch numbers L08D091, Exp 2010; L08D223, Exp 2010; L08E161,Exp 4/2010; L08F111, Exp 5/2010;

9) Batch no. L08D22, Exp 2010; L08E201,Exp 4/2010; L08F102, Exp 5/2010;

10) Batch Mo. L08C192, Exp 2/2010; L08D171, Exp 3/2010; L08E121, Exp 4/2010; L08E131, Exp 4/2010;

11) Batch L08C201, Exp 2/2010; L08E071, Exp 4/2010; L08E091, Exp 4/2010;

12) Batch L08D032, Exp. 3/2010; L08E061, Exp. 4/2010;

13) Batch L08E271, Exp. 4/2010; L08E281, Exp 4/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Advent Pharmaceuticals Inc, East Windsor, NJ, 
Manufacturer: Neilgen Pharmaceutical Inc, dba Unigen Pharmaceuticals, Westminster, MD. 
REASON Unapproved Drug
VOLUME OF PRODUCT IN COMMERCE
171,272 units
DISTRIBUTION GA, NC

PRODUCT 
1) BusPIRone HCl Tablets, USP, 5 mg, packaged in 100 tablet bottles (NDC 58177-264-04) and 500 tablet bottles (NDC 58177-264-08), 12/case, Rx only. ;

2) BusPIRone HCl Tablets, USP, 10 mg, packaged in 100 tablet bottles (NDC 58177-265-04) and 500 tablet bottles, NDC 58177-265-08, 12/case, Rx only. 

3) BusPIRone HCl Tablets, USP, 15 mg, packaged in 100 tablet bottles (NDC 58177-309-04) and 500 tablets bottles (NDC 58177-309-08), 12/case, Rx only. 

4) Codeine Phosphate and Guaifenesin Tablets, CIII, 10 mg/300 mg, each tablet contains 10 mg codeine phosphate and 300 mg guaifenesin, packaged in 100 tablet bottles, 12/case, Rx only, NDC 58177-223-04. 

5) Doxazosin Mesylate Tablets, 1 mg, packaged in 100 tablet bottles NDC 58177-266-04 and 500 tablet bottles NDC 58177-266-08, 12/case, Rx only. 

6) Doxazosin Mesylate Tablets, 2 mg, packaged in 100 tablet bottles NDC 58177-267-04 and 500 tablet bottles NDC 58177-267-08, 12/case, Rx only. 

7) Doxazosin Mesylate Tablets, 4 mg, packaged in 100 tablet bottles NDC 58177-268-04 and 500 tablet bottles NDC 58177-268-08, 12/case, Rx only.  

8) Doxazosin Mesylate Tablets, 8 mg, packaged in 100 tablet bottles NDC 58177-269-04 and 500 tablet bottles NDC 58177-269-08, 12/case, Rx only.

9) Guaifenex DM, (Guaifenesin/Dextromethorphan HBr), Extended-Release Tablets, 600 mg/30 mg, each tablet contains 600 mg guaifenesin and 30 mg dextromethorphan HBr, packaged in 100 tablet bottles, Rx only, NDC 58177-213-04. 

10) Guaifenex PSE 120, (Guaifenesin/Pseudoephedrine HCl), Extended-Release Tablets, 600 mg/120 mg, each tablet contains 600 mg guaifenesin and 120 mg pseudoephedrine HCl, packaged in 100 tablet bottles, 12/case, Rx only, NDC 58177-208-04. 

11) Hista-Vent DA Extended-Release Tablets, (Chlorpheniramine Maleate/Phenylephrine Hydrochloride/Methscopolamine Nitrate), 8 mg/20 mg/2.5 mg, each tablet contains 8 mg chlorpheniramine maleate, 20 mg phenylephrine hydrochloride, and 2.5 mg methscopolamine nitrate, packaged in 100 tablet bottles, 12/case, Rx only, NDC 58177-227-04. 

12) Hista-Vent PSE Tablets, (Pseudoephedrine HCl/Chlorpheniramine Maleate/Methscopolamine Nitrate), 120 mg/8 mg/2.5 mg, each extended-release tablet contains 120 mg pseudoephedrine HCl, 8 mg chlorpheniramine maleate, and 2.5 mg methscopolamine nitrate, packaged in 100 tablet bottles, Rx only, NDC 58177-426-04. 

13) Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg, packaged in 100 tablet bottles, Rx only, NDC 58177-237-04. 

14) Hyoscyamine Sulfate Tablets, USP, 0.125 mg, packaged in 100 tablet bottles, Rx only, NDC 58177-274-04. 

15) Hyoscyamine Sulfate Orally Disintegrating Tablets, 0.125 mg, packaged in 100 tablet bottles, 12/case, Rx only, NDC 58177-423-04. 

16) Hyoscyamine Sulfate Sublingual Tablets, USP, 0.125 mg, packaged in 100 tablet bottles, 12/case, Rx only, NDC 58177-255-04. 

17) Plaretase 8000 (pancrelipase, USP) Tablets, each tablet contains 8,000 USP units lipase, 30,000 USP units protease, and 30,000 USP units amylase, packaged in 100 tablet bottles (NDC 58177-416-04) and 500 tablet bottles (NDC 58177-416-08), Rx only. 
CODE
1) Lot numbers 75890, 75891, 79838, 81133, 86318, and 89677, expiration dates 1/2009-10/2009;

2) Lot numbers 83500, 83501, 83502, 84068, 84069, 84070, 87574, and 90080, expiration dates 3/2009-11/2009;

3) Lot numbers 75889, 79837, 81130, 81131, 81132, 84071, 84072, and 88480, expiration dates 2/2009-1/2010;

4) Lot numbers 85545, 89676, and 90060, expiration dates 4/2009-9/2009;

5) Lot numbers 74028, 75956, 75957, 82298, 82299, 84203, and 90464, expiration dates 7/2009-2/2011;

6) Lot numbers 73952, 73953, 75958, 75959, 81189, 81190, 82300, 83496, 83497, 84314, 89734, and 89088, expiration date 7/2009-12/2010;

7) Lot numbers 73760, 73965, 73968, 75960, 75961, 76287, 81193, 81194, 81195,

81196, 81197, 84317, 86504, 86505, 86517, 87007, 87200, 87376, and 87377, expiration dates 4/2009-4/2011;

8) Lot numbers 71709, 73969, 75962, 75963, 80518, 81201, 81202, 81630, 82301, 82302, 84319, 84321, 89738, 98085, expiration dates 5/2009-1/2011;

9) Lot numbers 75845, 84051, and 85547, expiration dates 4/2010-6/2010;

10) Lot numbers 84699, 85550, 85551, and 85965, expiration dates 4/2011-5/2011;

11) Lot numbers 70526, 71639, 72689, 77932, 79676, 81116, 82546, 84056, 87460, 89082, 89956, and 90775, expiration dates 12/2008-2/2011;

12) Lot numbers 72859, 74005, 76288, 81117, 84057, 91552, and 91553, expiration dates 7/2009-2/2011;

13) Lot numbers 66002, 67917, 72701, 75074, 76681, 81296, 81297, 82353, 83918, 87698, 88459, 88911, 89162, 89181, 89645, 89771, 90177, and 90178, expiration dates 11/2008-1/2011;

14) Lot numbers 75077, 77914, 79883, 81300, 82357, 82358, 88919, 89028, 89648, and 90193, expiration dates 8/2009-2/2011;

15) Lot numbers 72837, 75075, 75076, 77911, 77912, 82355, 82356, and 84016, expiration dates 5/2009-10/2010;

16) Lot numbers 72821, 74115, 77909, 81298, 81299, 82354, 83338, 89646, 89772, 90187, and 90188, expiration dates 5/2009-1/2011;

17) Lot numbers 73764, 73765, 76042, 76044, 77918, 81289, 82339, 84777, 90163, 90164, 90165, 90166, 90167, 90901, and 90902, expiration dates 4/2009-4/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethex Corporation, Bridgeton, MO, 
Manufacturer: KV Pharmaceutical Co Westport, Saint Louis, MO. 
REASON The products may contain oversized tablets.
VOLUME OF PRODUCT IN COMMERCE
5,694.360 bottles (The volume is a total of all products recalled by Ethex  in this Enforcement Report
DISTRIBUTION Nationwide

PRODUCT 
1) Thyro-Tab (levothyroxine sodium tablets), 0.25 mg. packaged in bulk drums intended for repackaging, RX only. 

2) Levothroid (levothyroxine sodium tablets, USP), 25 mcg, packaged in 100- and 1,000-tablet bottles, NDC 0456-1320-01 (100-tab.) and NDC 0456-1320-00 (1,000-tab.), RX only. 
CODE
1) Lot # HA29807, Exp. Nov 2008;
2) Lots120702 (100-tab) and 120701 (1,000-tab), Exp. Nov 2008
RECALLING FIRM/MANUFACTURER
Lloyd Inc of Iowa, Shenandoah, IA,
REASON Subpotent; 10-month test interval
VOLUME OF PRODUCT IN COMMERCE
Thyro-Tab - 1,947,583 bulk tablets; Levothroid 25 mcg - 9,039/100-tab. bottles; 960/1,000-tab. bottles.
DISTRIBUTION Nationwide

PRODUCT  Citalopram Hydrobromide Tablets, USP, 10 mg, 500 tablet bottles, Rx only, NDC 57664-507-13, 
CODE Lot: 82577A
RECALLING FIRM/MANUFACTURER
Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI, 
REASON Some of the tablets are oversized or undersized, which will result in the patient not receiving the expected dose.
VOLUME OF PRODUCT IN COMMERCE
449 bottles
DISTRIBUTION Nationwide

PRODUCT 
1) ComBgen Tablets, each tablet contains 2.2 mg folic acid, 25 mg Vitamin B6, and 500 mcg Vitamin B12, packaged in 100 tablet bottles, 12/case, Rx only, NDC 58177-440-04. 

2) EtheDent Chewable Tablets, 0.5 mg F (From 1.1 mg sodium fluoride), Sodium Fluoride Chewable Tablets, Grape Flavored, packaged in 120 tablet bottles NDC 58177-433-40 and 1,000 tablet bottles NDC 58177-433-09, 12/case, Rx only. 

3) EtheDent Chewable Tablets, 1 mg F (From 2.2 mg sodium fluoride), Sodium Fluoride Chewable Tablets, Cherry Flavored, packaged in 120 tablet bottles, 12/case, NDC 58177-434-40, Rx only. 

4) NatalCare GlossTabs, Prenatal Vitamins-Gloss Coated Oral Tablets, packaged in 90 tablet bottles, 12/case, Rx only, NDC 58177-418-26. 

5) NatalCare PIC Forte, Prenatal Multivitamin/Mineral Tablets with Polysaccharide-Iron Complex, packaged in 100 tablet bottles, 12/case, Rx only, NDC 58177-258-04, 

6) NatalCare Plus, Prenatal Multivitamin/Mineral Tablets, packaged in 100 tablet bottles, 12/case, Rx only, NDC 58177-225-04. 

7) Prenatal MTR with Selenium, Prenatal Multivitamin/Mineral Tablets, packaged in 100 tablet bottles, 12/case, NDC 58177-316-04, Rx only. 

8) Colgate Luride 0.25 mg F Brand of Sodium Fluoride, Quarter-Strength Lozi-Tabs Brand of Lozenge-Type Tablets, Vanilla Flavor, packaged in 120 tablet bottles, Rx only, NDC 0126-0186-21. 

9) Colgate Luride, 1 mg F, Brand of Sodium Fluoride, Full-Strength Lozi-Tabs Brand of Lozenge-Type Tablets, Cherry Flavor, packaged in 120 tablet bottles, Rx only, NDC 0126-0006-21. CODE
1) Lot numbers 75954, 90428, and 90429, expiration dates 12/2008-1/2010;
2) Lot numbers 82330, 86325, 89760, 96318, and 99074, expiration dates 10/2009-9/2011;
3) Lot numbers 84077 and 90107, expiration dates 10/2010-4/2011;
4) Lot numbers 82384, 82385, and 90534, expiration dates 7/2009-1/2010;
5) Lot 77215, Exp. 7/2009;
6) Lot numbers 86283, 86462, and 86463, expiration date 5/2009;
7) Lot 80338, Exp. 8/2009;
8) Lot 87850, Exp. 8/2010; 91327, Exp. 3/2011; and 91507, Exp. 1/2011;
9) Lot 82701, Exp. 8/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethex Corporation, Bridgeton, MO, 
Manufacturer: KV Pharmaceutical Co Westport, Saint Louis, MO. F.
REASON The products may contain oversized tablets.
VOLUME OF PRODUCT IN COMMERCE
5,694,360 bottles (The volume is a total of all products recalled by Ethex in this Enforcement Report.
DISTRIBUTION Nationwide

PRODUCT  Sotret Isotretinoin Capsules USP, 40 mg, 10 capsule blister packs/carton, Rx only, NDC 10631-586-77. 
CODE Lot # 1876846, 2/28/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ranbaxy Pharmaceuticals, Inc, Princeton, NJ, .
Manufacturer: Ranbaxy Laboratories, Limited, Simour District, India. 
REASON Out of Specification: Dissolution test showed out of specification results.
VOLUME OF PRODUCT IN COMMERCE
1303 cartons, each containing 100 capsules (10 x 10 Blister Pack)
DISTRIBUTION Nationwide

PRODUCT  Citalopram Hydrobromide Tablets, USP, 40 mg, 100 tablet bottles, Rx only, NDC 57664-509-88. 
CODE Lot # 81940A
RECALLING FIRM/MANUFACTURER
Caraco Pharmaceutical Laboratories, Ltd, Detroit, MI, .
REASON The product does not dissolve as rapidly as required by its specifications.
VOLUME OF PRODUCT IN COMMERCE
19,392 bottles
DISTRIBUTION Nationwide

WEEK ENDING JULY 4

PRODUCT

Senna Laxative (Standardized Senna Concentrate) sennosides 8.6 mg. per tablet, OTC, packaged under distributor labels: Equaline brand, 50 tablets, NDC 41163-021-71; 100 tablets, NDC 41163-021-78 and 250 tablets, NDC 41163-021-85; Meijer brand, 100 tablets, NDC 41250-021-78; Hannaford brand, 100 tablets, NDC 41268-021-78; Natural brand, 100 tablets, NDC 38045-021-78; TopCare brand, 100 tablets, NDC 36800-021-78; GoodSense brand, 100 tablets, NDC 0113-0021-78; CareOne brand, 100 tablets, no NDC #; HyVee brand, 100 tablets, NDC 42507-021-78; Kroger brand, 100 tablets, NDC 30142-021-78; Longs brand, 100 tablets, NDC 12333-9611-1; and Sunmark brand, 100 tablets, NDC 49348-262-10.

CODE

Lots 7JE0529, 7LE0537, 7ME0269, 8AE0404, 8BE0070, 8BE0071, 8BE0087, 8BE0746, 8CE0043, 8CE0501, 8CE0502, 8FE0688, 8GE0279, 8GE0526 and 8GE1213

RECALLING FIRM/MANUFACTURER

Recalling Firm: L Perrigo Co, Allegan, MI

Manufacturer: Time-Cap Labs, Farmingdale, NY. 

REASON

Product contains undeclared anhydrous lactose and tartaric acid.

VOLUME OF PRODUCT IN COMMERCE

218,220 bottles

DISTRIBUTION Nationwide

PRODUCT Baxter Potassium Chloride for Injection Concentrate, USP (2 mEq/mL); 250 mL Glass Pharmacy Bulk Package, Not for Direct Infusion; NDC 0338-0318-02. 

CODE Lots: G075556 and G076539

RECALLING FIRM/MANUFACTURER

Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL, .

Manufacturer: Baxter Healthcare Corporation, Cleveland, MS. 

REASON Stability data does not support expiration date (pH).

VOLUME OF PRODUCT IN COMMERCE

28,706 units

DISTRIBUTION Nationwide, Canada, Hong Kong, Oman and Saudi Arabia

PRODUCT

1) Shop Rite Cough Formula DM Cough Suppressant Expectorant, (dextromethorphan HBr 10 mg and guaifenesin 100 mg), Cherry Flavor, 8 fl. oz (237 mL); UPC 0 41190 22044 1; Item code 7056191. 

2) Shop Rite Tussin Chest Congestion Formula, (Guaifenesin Oral Solution, USP), 100 mg, 8 fl. oz. (237 mL). UPC 0 41190 22151; Item Code 7055933. 

CODE

a) Lot number 106295, Exp. date 10/31/10;

b) Item Code 7055933 only

RECALLING FIRM/MANUFACTURER

Accumed Inc, Lawrenceville, NJ,

REASON

Mis-packed: Some boxes of Shop Rite Cough Formula DM Cough Suppressant Expectorant may actually contain 8 oz. bottles of Shop Rite Tussin Chest Congestion Formula.

VOLUME OF PRODUCT IN COMMERCE

10,128 8 oz bottles (844 x 12 oz cases)

DISTRIBUTION NJ

PRODUCT Adagen (pegademase bovine) injection, four 1.5 ml single-dose vials, 250 units per mL, sterile, refrigerate, Rx only; NDC 57665-001-01. 

CODE Lot 8116A; exp 5/21/2009 and lot 8118A; exp 5/21/2009

 RECALLING FIRM/MANUFACTURER

Enzon Pharmaceuticals Inc, Indianapolis, IN

REASON Exceeded Impurity Specification; 6 month stability testing.

VOLUME OF PRODUCT IN COMMERCE

308 4-vial packs

DISTRIBUTION TN, Australia, Colombia and France

PRODUCT

1) Kids Kare Plus 0.4% Stannous Flouride Brush-on Dentifrice Anticavity Toothpaste; Net Wt. 4.3 oz. (122g); Mint flavor; NDC #59883-631-04, Reorder #2231MT. 

2) Kids Kare Plus 0.4% Stannous Flouride Brush-on Dentifrice Anticavity Toothpaste; Net Wt. 4.3 oz. (122g); Bubblegum flavor; NDC #59883-633-04, Reorder #2231BG. 

3) Kids Kare Plus 0.4% Stannous Flouride Brush-on Dentifrice Anticavity Toothpaste; Net Wt. 4.3 oz. (122g); Grape flavor; NDC #59883-636-04, Reorder #2231GR.  

4) PerioCheck 0.4% Stannous Flouride Preventative Treatment Brush On Gel; Net Wt. 4.3 oz. (122g); Mint flavor; NDC #59883-611-04, DIN #02117371, Reorder #2230MT. 

5) Pro-Den Rx Neutral Sodium Fluoride Topical Gel (1.1% Sodium Fluoride (500 ppm Fluoride Ion)); Net Wt. 2.0 oz. (56g); Prescription; Cherry Limeade flavor; NDC #59883-807-02, Reorder #2240CL. 

CODE

1) Lot #132122, 131120, 130102 and 130129;

2) Lot #130314, 130307, 131307 and 131314;

3) Lot #130808, 131817 and 131814;

4) Lot #68117;

5) Lot #810117, 810102, 811130, 810113, and 810111

RECALLING FIRM/MANUFACTURER

Zila Therapeutics, Inc. Batesville, AK,

REASON Subpotent Fluoride

VOLUME OF PRODUCT IN COMMERCE

23,424 units

DISTRIBUTION Nationwide

PRODUCT Diphenhydramine HCL, USP 25 mg, softgel capsules 12 counts blister cards. 

CODE Lot # 28040096

RECALLING FIRM/MANUFACTURER

Banner Pharmacaps, Inc, High Point, NC

REASON Failed USP Dissolution testing at 3-month stability timepoint.

VOLUME OF PRODUCT IN COMMERCE

599,040 soft gel capsules

DISTRIBUTION NY

PRODUCT Oxycodone Hydrochloride Oral Solution, USP, 5 mg/mL, C-II packaged in 5  mL unit dose cups (50 unit Dose Cups/case) and 500 mL bottles (12 bottles/case), Rx only, Unit dose NDC 66689-024-50, Bottle NDC 66689-024-16. 

CODE Lot # 165300, exp 6/11; Lot # 165200, exp 6/11

RECALLING FIRM/MANUFACTURER

VistaPharm, Inc., Largo, FL,

REASON The product is mis-labeled in that the expiration date issued exceeds the current expiration date duration that is assigned.

VOLUME OF PRODUCT IN COMMERCE

47,750 unit dose cups, and 24 bottles

DISTRIBUTION Nationwide

PRODUCT Xopenex (levalbuterol HC1) Inhalation Solution; 1.25mg/3mL; Sterile Unit-Dose Vials. 

CODE Lot # S8F072, exp 22/09 (on pouch); exp. 12/09 (on vial/carton label)

RECALLING FIRM/MANUFACTURER

Recalling Firm: Sepracor, Inc., Marlborough, MA, 

Manufacturer: Catalent Pharma Solutions, LLC, Woodstock, IL. 

REASON Incorrect Expiration Date

VOLUME OF PRODUCT IN COMMERCE

20,000 units

DISTRIBUTION OH, TN