NOVEMBER 2009

WEEK ENDING NOVEMBER 28

PRODUCT Stamina Rx, Maximum Sexual Stimulant, Dietary Supplement, 550 mg proprietary blend herbal ingredients, sold in 10, 30 and 40 tablet bottles and in 2 and 6 tablet blister packs. 
CODE All lot numbers
RECALLING FIRM/MANUFACTURER
Hi Tech Pharmaceuticals, Norcross, GA, 
REASON
Unapproved new drug; product contains benzamidenafil.
VOLUME OF PRODUCT IN COMMERCE
18 million tablets
DISTRIBUTION Nationwide

PRODUCT Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), 100 mg Single Use Vial, For IV Use only, Sterile lyophilized Suspension, Rx Only, NDC 68817-134-50 --- Australian label: Abraxane 100 mg Nanoparticle albumin-bound paclitaxel powder for injection (suspension) For Intravenous Use Only, PRESCRIPTION ONLY MEDICINE --- Each vial contains: paclitaxel 100 mg, Human Albumin 900 mg --- Abraxis BioScience LLC Distributed in Australia. 
CODE
Lots 406580 (exp. 6/30/2010), 407545 (exp. 6/30/2010), 406427 (exp 9/30/2010), 406453 (exp. (9/30/2010), 406617 (exp. 10/31/2010), 407150 (exp. 2/28/2011). Product Code 103450 and AU103450 (Australia)
This recall has been expanded to include the following lots, but is NOT a new recall and distribution now also includes the European Union:
Product Code 103450 - lots: 404941(exp. 11/30/2009), 404987 (exp. 11/30/2009), 405138 (exp. 12/31/2009), 405265 (exp. 2/28/2010), 405301 (exp. 1/31/2010), 405307 (exp. 1/31/2010), 405385 (exp. 2/28/2010), 405479 (exp. 3/31/2010), 405512 (exp. 3/31/2010), 405548 (exp. 3/31/2010), 405575(exp. 3/31/2010), 406143 (exp. 7/31/2010), 406177 (exp. 7/31/2010),  406178 (exp. 7/31/2010), 406271 (exp. 8/31/2010), 406315 (exp. 8/31/2010), 406355 (exp. 8/31/2010), 406392 (exp. 8/31/2010);  Product Code E103450*  - lot XL18A1/405693* (exp. 12/31/2009*): Product Code UK103450* - lot 405693A* (exp. 12/31/2009*); Product Code GM103450* - lot 405693B* (exp. 12/31/2009*).  [NOTE: * Lot 405693 was distributed clinically in Germany as Lot XL18A1.  Lot 405693A was distributed commercially in the United Kingdom.  Lot 405693B was distributed commercially in Germany.] 

PRODUCT 
1) Senna-Time Micro-Coated Clear Tablets, Sennosides 8.6mg, NDC 63739-431-10, packed in 100 and 750 tablet blister pack, unit dose containers. 

2) Senna-Time S Film Coated Orange Tablets, Natural Vegetable Laxative Plus Softener, NDC 63739-432-10, packed in 100 and 750 tablet blister pack, unit dose containers. 
CODE
1) Lot numbers: 57536, 56922, 54816, 51962, 46183, 48214 and 51943;
2) Lot numbers: 46182, 55485, 57950, 54082, 58319, 59996 and 48196
RECALLING FIRM/MANUFACTURER
Recalling Firm: McKesson Packaging Services, Concord, NC,
Manufacturer: Time-Cap Laboratories, Inc., Farmingdale, NY. 
REASON
Product may contain undeclared anhydrous lactose and tartaric acid.
VOLUME OF PRODUCT IN COMMERCE
63,680 boxes
DISTRIBUTION Nationwide

PRODUCT Motrin IB/Ibuprofen Tablets, 200 mg/650 mg, 8 count Coated Caplets, NDC 50580-110-68. 
CODE Lot numbers: SHC003, SHC004
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Products, Co., Fort Washington, PA, 
Manufacturer: McNeil Consumer and Specialty Pharmaceuticals, Las Piedras, PR. 
REASON
Failed USP Dissolution Specifications; 3 month stability test interval.
VOLUME OF PRODUCT IN COMMERCE
88,104 tablets
DISTRIBUTION Nationwide

PRODUCT Phentermine Hydrochloride, USP, 37.5 mg, 100 count bottle, Rx only, NDC 0603-5192-21. 
CODE Lot No. T058E09A, expiration date May 2012
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, 
REASON
Super Potent Single Ingredient Drug Product: The manufacturer received a product complaint of large tablet thickness for 2 tablets. The manufacturer's investigation determined that tablets contained 136.1% more active ingredient than as specified on product label.
VOLUME OF PRODUCT IN COMMERCE
28,309 bottles
DISTRIBUTION Nationwide

PRODUCT 
1) Allopurinol Tablets USP, 300 mg, 1000-count bottle, Rx only, NDC 60505-2517-03. 

2) Amlodipine Besylate Tablets, 10 mg, 1000-count bottle, Rx only, NDC 60505-0195-03. 

3) Benazepril Hydrochloride Tablets, 10 mg, 100-count bottle (NDC 60505-0266-01), 500-count bottle (NDC 60505-0266-05), Rx only. 

4) Benazepril Hydrochloride Tablets, 20 mg, 100-count bottle (NDC 60505-0267-01), 500-count bottle (NDC 60505-0267-05), Rx only. 

5) Benazepril Hydrochloride Tablets, 40 mg, 100-count bottle (NDC 60505-0268-01), 500-count bottle (NDC 60505-0268-05), Rx only. 

6) BuPROPion Hydrochloride Tablets USP, 100 mg, 500-count bottle, Rx only, NDC 60505-0157-05. 

7) BuPROPion Hydrochloride Tablets USP, 75 mg, 90-count bottle (NDC 60505-0158-09), 500-count bottle (NDC 60505-0158-05), Rx only. 

8) Carvedilol Tablets, 12.5 mg, 100-count bottle (NDC 60505-2608-01), 1000-count bottle (NDC 60505-2608-08), Rx only. 

9) Carvedilol Tablets, 25 mg, 100-count bottle (NDC 60505-2609-01), 1000-count bottle (NDC 60505-2609-08), Rx only.

10) Carvedilol Tablets, 3.125 mg, 100-count bottle (NDC 60505-2606-01), 1000-count bottle (NDC 60505-2606-08), Rx only. 

11) Carvedilol Tablets, 6.25 mg, 100-count bottle (NDC 60505-2607-01), 1000-count bottle (NDC 60505-2607-08), Rx only. 

12) Cefprozil Tablets USP, 250 mg, 100-count bottle, Rx only, NDC 60505-2532-01. 

13) Cefprozil Tablets USP, 500 mg, 50-count (NDC 60505-2533-05), 100-count (NDC 60505-2533-01), Rx only. 

14) Cimetidine Tablets USP, 200 mg, 2 kg bottle, OTC, THIS CONTAINER IS FOR REPACKAGE ONLY, NDC 60505-0149-00. 

15) Cimetidine Tablets USP, 400 mg, 500-count bottle, Rx only, NDC 60505-0020-08. 

16) Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, NDC 60505-1309-01.

17) Citalopram HBr Tablets, 40 mg, 100-count bottle, Rx only, NDC 60505-2520-01.

18) Clonazepam Tablets USP, 0.5 mg, 100-count (NDC 60505-0066-01), 500-count bottle (NDC 60505-0066-03), Rx only.

19) Clonazepam Tablets USP, 1 mg, 100-count bottle (NDC 60505-0067-01), 500-count (NDC 60505-0067-03), Rx only. 

20) Clonazepam Tablets USP, 2 mg, 100-count bottles (NDC 60505-0068-01), 500-count bottles (NDC 60505-0068-03), Rx only.  

21) CycloSPORINE Capsules USP, 100 mg, 30-count bottle, Rx only, NDC 60505-0134-00. 

22) CycloSPORINE Capsules USP, 25 mg, 30-count bottles, Rx only, NDC 60505-0133-00. 

23) Diclofenac Potassium Tablets, 50 mg, 100-count bottle, Rx only, NDC 60505-0135-00.

24) DILT-CD (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 120 mg, 90-count bottle (NDC 60505-0007-04), 500-count bottle (NDC 60505-0007-08), Rx only. 

25) DILT-CD (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 180 mg, 90-count bottle (NDC 60505-0008-04), 500-count bottle (NDC 60505-0008-08), Rx only. 

26) DILT-CD (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 240 mg, 90-count bottle (NDC 60505-0009-04), 500-count bottle (NDC 60505-0009-08), Rx only. 

27) DILT-CD (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 300 mg, 90-count bottle (NDC 60505-0010-04), 500-count (NDC 60505-0010-08), Rx only. 

28) DILTZAC (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 120 mg, 30-count bottle (NDC 60505-0210-03), 90-count bottle (NDC 60505-0210-09), Rx only, 

29) DILTZAC (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 180 mg, 30-count bottle (NDC 60505-0211-03), 90-count bottle (NDC 60505-0211-09), Rx only, 

30) DILTZAC (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 240 mg, 90-count bottle, Rx only, NDC 60505-0212-09. 

31) DILTZAC (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 300 mg, 30-count bottles (NDC 60505-0213-03), 90-count bottles (NDC 60505-0213-09), Rx only. 

32) DILTZAC (diltiazem hydrochloride) Extended-Release Capsules USP, (Once-a-day dosage), 360 mg, 30-count bottle (NDC 60505-0214-03), 90-count bottle (NDC 60505-0214-09), Rx only. 

33) Divalproex Sodium Delayed-Release Tablets USP, 500 mg, 100-count bottle (NDC 60505-3067-01), 500-count bottle (NDC 60505-3067-05), Rx only.

34) Eplerenone Tablets, 25 mg, 30-count bottle (NDC 60505-2651-03), 90-count bottle (NDC 60505-2651-09), Rx only. 

35) Eplerenone Tablets, 50 mg, 30-count bottle (NDC 60505-2652-03), 90-count bottle (NDC 60505-2652-09), Rx only. 

36) Etodolac Tablets USP, 500 mg, 100-count bottle, Rx only, NDC 60505-0102-01. 

37) Fosinopril Na Tablets, 20 mg, 90-count bottle (NDC 60505-2511-02), 1000-count bottle (NDC 60505-2511-04), Rx only. 

38) Fosinopril Na Tablets, 40 mg, 1000-count bottle, Rx only, NDC 60505-2512-08. 

39) Gabapentin Capsules, 300 mg, 3500-count bottle, Rx only, NDC 60505-0113-07. 

40) Gabapentin Tablets, 600 mg, 500-count bottle, Rx only, NDC 60505-2551-05. 

41) Gabapentin Tablets, 800 mg, 500-count bottle, Rx only, NDC 60505-2552-05. 

42) Gemfibrozil Tablets USP, 600 mg, 60-count bottle (NDC 60505-0034-04), 100-count bottle (60505-0034-01), 100-count box (10 x 10 Unit dose) (NDC 60505-0034-00), 180-count bottle (GSMS, Inc.) (NDC 60429-0081-18), 2500-count bottle (NDC 60505-0034-06), 500-count bottle (60505-0034-08), Rx only.  

43) Lithium Carbonate Capsules USP, 300 mg, 100-count bottle (NDC 60505-2504-01), 100-count box (10 x 10 Unit dose) (NDC 60505-2504-03), 1000-count bottle (NDC 60505-2504-02), Rx only. 

44) Meloxicam Tablets, 7.5 mg, 100-count bottle, Rx only, NDC 60505-2553-01. 

45) Metformin Hydrochloride Tablets, 1000 mg, 100-count bottle (NDC 60505-0192-00), 500-count bottle (NDC 60505-0192-01), 1000-count bottle (NDC 60505-0192-08), 2000-count bottle (NDC 60505-0192-04), Rx only. 

46) Metformin Hydrochloride Tablets, 500 mg, 100-count bottle (NDC 60505-0190-00), 100-count bottle (BRITESTOCK) (NDC 7713-1316-963), 500-count bottle (NDC 60505-0190-01), 1000-count bottle (NDC 60505-0190-08), 4500-count bottle (NDC 60505-0190-04), Rx only. 

47) Metformin Hydrochloride Tablets, 850 mg, 100-count bottle (NDC 60505-0191-00), 500-count bottle (NDC 60505-0191-01), 2500-count bottle (NDC 60505-0191-04), Rx only. 

48) Metformin Hydrochloride Extended-Release Tablets, 500 mg, 100-tablet bottle (NDC 60505-0260-01), 500-count bottle (NDC 60505-0260-02), 2500-count bottle (NDC 60505-0260-07), Rx only. 

49) Omeprazole Delayed-Release Capsules USP, 20 mg, 30-count bottle (NDC 60505-0065-00), 100-count box (10 x 10 unit dose) (NDC 60505-0065-07), 1000-count bottle (NDC 60505-0065-01), 5000-count bottle (NDC 60505-0065-08), Rx only. 

50) Omeprazole Delayed-Release Capsules USP, 40 mg, 30-count bottle, Rx only, NDC 60505-0146-00. 

51) Oxaprozin Tablets USP, 600 mg, 500-count bottle, Rx only, NDC 60505-0176-01. 

52) Oxcarbazepine Tablets, 150 mg, 100-count bottle (NDC 60505-2534-01), 100-count box (10 x 10 unit dose) (NDC 60505-2534-00), 500-count bottle (NDC 60505-2534-05). 

53) Paroxetine Tablets USP, 10 mg, 30-count bottle (NDC 60505-0097-01), 100-count bottle (NDC 60505-0097-02), 1000-count bottle (NDC 60505-0097-04), Rx only. 

54) Paroxetine Tablets USP, 20 mg, 30-count bottle, Rx only, NDC 60505-0083-01. 

55) Paroxetine Tablets USP, 30 mg, 30-count bottle, Rx only, NDC 60505-0084-01. 

56) Paroxetine Tablets USP, 40 mg, 30-count bottle (NDC 60505-0101-01), 100-count bottle (NDC 60505-0101-02), 1000-count bottle (NDC 60505-0101-04), Rx only.

57) Quinapril Tablets USP, 10 mg, 90-count bottle (NDC 60505-0173-00), 1000-count bottle (NDC 60505-0173-01), Rx only. 

58) Quinapril Tablets USP, 20 mg, 90-count bottle (NDC 60505-0174-00), 1000-count bottle (NDC 60505-0174-01), Rx only. 

59) Quinapril Tablets USP, 40 mg, 90-count bottle (NDC 60505-0175-00), 1000-count bottle (NDC 60505-0175-01), Rx only. 

60) Quinapril Tablets USP, 5 mg, 90-count bottle, Rx only, NDC 60505-0172-00. 

61) Ranitidine Tablets USP, 150 mg, 60-count bottle (NDC 60505-0025-04), 60-count bottle (GSMS, Inc.) (NDC 60429-0704-60), 100-count bottle (NDC 60505-0025-06), 180-count bottle (GSMS Inc.) (NDC 60429-0704-18), 500-count bottle (GSMS Inc.) (NDC 60429-0704-05), 500-count bottle (NDC 60505-0025-08), 10000-count bottle (GSMS Inc.) (NDC 60429-0704-00). 

62) Ranitidine Tablets USP, 300 mg, 30-count bottle (GSMS, Inc.) (NDC 60429-0705-30), 100-count bottle (NDC 60505-0026-03), 250-count bottle (GSMS, Inc.) (NDC 60429-0705-25), 250-count bottle (NDC 60505-0026-07). 

63) Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, 473 mL bottle, Rx only, NDC 60505-0351-01. 

64) Terbinafine Hydrochloride Tablets, 250 mg, 30-count bottle (NDC 60505-2572-03), 100-count bottle (NDC 60505-2572-01), Rx only. 

65) Topiramate Tablets, 200 mg, 60-count bottle, Rx only, NDC 60505-2763-06. 

66) Torsemide Tablets, 20 mg, 100-count bottle, Rx only, NDC 60505-0234-01. 

67) Tramadol Hydrochloride Tablets, 50 mg, 100-count bottle (NDC 60505-0171-01), 500-count bottle (NDC 60505-0171-02), 1000-count bottle (NDC 60505-0171-08), Rx only. 

68) Zolpidem Tartrate Tablets, 10 mg, 100-count bottle (NDC 60505-2605-01), 100-count box (10 x 10 Unit dose) (NDC 60505-2605-00), 1000-count bottle (NDC 60505-2605-08), Rx only.

69) Zolpidem Tartrate Tablets, 5 mg, 100-count bottle (NDC 60505-2604-01), 1000-count bottle (NDC 60505-2604-08), Rx only. 

70) Etodolac Tablets USP, 400 mg, 100-count bottle, Rx only, NDC 60505-0041-01. 

71) Oxcarbazepine Tablets, 600 mg, 100-count bottle (NDC 60505-2536-01), 100-count box (10 x 10 Unit dose) (NDC 60505-2536-00), 500-count bottle (NDC 60505-2536-05), Rx only. 

72) Cimetidine Tablets, 800 mg, 100-count bottle (NDC 60505-0021-03), 250-count bottle (NDC 60505-0020-07), Rx only. 

73) Cetirizine Hydrochloride Tablets, 10 mg, 100-count bottle, OTC, NDC 60505-2633-01. 
CODE
1) Lot HR0069, Exp 01/10;

2) Lot HR2621, HP3312, Exp 11/09; Lot HV1015, Exp 03/10;

3) Lot JA5526, Lot JA5527, Exp 11/10;

4) Lot JA5536, JA5537, Exp 11/10; Lot JD1817, JD1819, Exp 01/11;

5) Lot JA5540, JA5542, JA5541, Exp 11/10; Lot JC2294, Exp 12/10;

6) Lot JA0966, Exp 05/10;

7) Lot JA0974, JA0968, Exp 05/10; Lot JC1965, Exp 06/10; Lot JC7388, Exp 07/10; Lot JD9958, Exp 10/10;

8) Lot HP0611, HP0612, Exp 11/09;

9) Lot HP0628, HP0630, HN1410, HP0631, HN1408, HN1406, Exp 10/09; Lot HP0629, Exp 11/09;

10) Lot HN1349, HN1351, Exp 10/09; Lot HT7439, Exp 02/10;

11) Lot HR0254, HP0602, HP0603, HP7608, Exp 11/09;

12) Lot HV0658, Exp 04/10; Lot HX4076, HX8122, Exp 07/10;

13) Lot HV0661, HV0663, HV0664, Exp 04/10;

14) Lot JA5149, JA5147, Exp 11/09;

15) Lot HT8899, Exp 03/10;

16) Lot HP9566, Exp 2/10; Lot HW5875, Exp 6/10; Lot HZ0890, HZ0896, HZ8033, JA0335, JA0336, JA0337, JA0338, JA0339, JA0341, JA0342, JA0347, JA0348, JA5588, JA5593, Exp 11/10; Lot HZ0889, JA0334, JA0344, JE3863, Exp 12/10;

17) Lot HW3043, Exp 05/10;

18) Lot HX5589, HX5587, Exp 06/10;

19) Lot HY6843, HW7772, HY6850, Exp 06/10; Lot JE7265, JE7287, Exp 04/11;

20) Lot HW7709, HX8337, HW7713, HX8338, Exp 06/10;

21) Lot HP9575, Exp 09/09; Lot JE8041, Exp 05/11;

22) Lot JE8043, Exp 05/11;

23) Lot HV3437, Exp 04/10; Lot HX3580, Exp 07/10;

24) Lot JA8607, Lot JA8603, Exp 09/10; Lot JD8735, JE0412, JD8734, JE0413, Exp 11/10;

25) Lot JA8598, JA8593, Exp 09/10;

26) Lot JA8586, Exp 09/10; Lot JD1487, Exp 10/10; Lot JC4543, Exp 11/10;

27) Lot JA8580, JA8577, Exp 10/10; Lot JD5693, Exp 12/10;

28) Lot JA8395, JA9103, JA9104, Exp 11/10;

29) Lot JC2074, JC2037, JC6029, Exp 11/10;

30) Lot JC7236, JC7237, Exp 11/10;

31) Lot JA8449, JC2092, JD2272, Exp 11/10;

32) Lot JC2085, JD1957, Exp 11/10; Lot JF3739, Exp 05/11;

33) Lot HN9548, HW7202, HW7203, HW7204, Exp 11/09; Lot HN9541, HN9549, Exp 12/09; Lot HN5227, HN9486, HN9495, HN9531, HN9536, HT6602, HT6605, Exp 01/10; Lot HV9738, HV9739, HZ0354, Exp 05/10; Lot HV9716, HV9718, HV9719, HV9721, HV9722, HV9723, HV9724, HV9731, HV9733, HV9734, HV9735, HV9736, HV9737, HV9720, HV9726, HV9727, HV9728, HV9729, HV9730, HV9740, HV9741, HV9742, HV9743, HV9744, HV9745, HV9746, HW7158, HW7163, HW7166, HW7168, HW7195, HW7197, Exp 06/10; Lot HZ4548, HZ4552, HT6604, HZ4549, JC2664, JC2665, Exp 10/10; Lot HZ4550, HZ4551, JD0026, JD0027, JD0028, JD0029, JD0030, JD0031, JD0032, JD0033, JD0034, JD0035, JD0036, JD0012, Exp 02/11; Lot JD6735, JD6736, JD6739, Exp 03/11; Lot JD6752, JD6753, JD6756, JD6757, JD6758, JD6759, JD6760, JE2006, JE2007, JE2008, JE2012, JE2013, JE2014, JD6737, JD6740, JE2015, JE2016, JE2017, JE2018, JE9815, JE9816, Exp 04/11;

34) Lot HT7013, HT7014, Exp 02/10; Lot JA1090, JA1091, Exp 11/10;

35) Lot HW0739, JA1741, JA1743, HW0738, JA1740, Exp 11/10;

36) Lot HN6979, Exp 12/09; Lot HW0830, Exp 04/10; Lot JA2056, Exp 11/10;

37) Lot HX7063, HX7062, Exp 07/10;

38)  Lot HX7104, Exp 07/10;

39) Lot HP3261, Exp 11/09; Lot JD5212, Exp 02/11;

40) Lot JE5764, Exp 09/10;

41) Lot JE7410, Exp 10/10;

42) Lot HM5301, HM5324, HM5329, HH7198, HH7199, HH7201, HH7202, HH7203, HJ1838, HJ1839, HK4525, HK4526, HK9383, HK9386, HK9387, HK9388, HM5280, HM5285, HM5295, Exp 09/09; Lot HJ1844, Exp 10/09; Lot HJ1843, HJ8194, HJ8195, HJ8196, HJ8197, HG5059, HG5060, Exp 11/09; Lot HT0980, HT1682, Exp 03/10; Lot JA2344, Exp 07/10; Lot JD4454, JC8491, JC8492, JC8493, JC8494, JD4436, JD4437, JD4438, JC8520, JC8521, JC8523, JC8524, JC8526, JC8527, JC8528, JC8532, Exp 02/11; Lot JD4439, Exp 03/11; Lot JF5346, Exp 05/11;

43) Lot HP8840, HP8834, HP8789, Exp 12/09; Lot HT3527, HT3533, HT3542, Exp 02/10; Lot HT3529, Exp 03/10;

44) Lot JD9477, JE2146, Exp 03/11;

45) Lot HM1984, HM1986, HM1990, HM1992, HM1994, HM1996, HM1999, HM2004, HM2006, HM2007, HM2009, HM2010, HM2011, HM2012, HM7290, HN2781, HN6305, HN6309, HP2811, HM1985, HM1987, HM1989, HM1991, HN2881, HM7301, HM7303, HM7304, HN2860, HN2868, Exp 09/09; Lot HM2018, HM2020, HN2889, HN2886, HN2862, HN2871, HN2872, HN2873, Exp 10/09; Lot HN2897, HP7399, HN7247, Exp 11/09; Lot HT2569, HT2571, HT2574, HT2576, HT2579, HT2582, HT2585, HT2588, HT2592, HT2601, HT9130, HT2508, HT2509, HT2510, HT2511, JC2151, HR7650, HT2498, HT2499, HT2500, HT2501, HT2503, Exp 03/10; Lot HT2597, HT9097, HT9098, HR0165, HT2495, HT2496, HT9075, HT2502, HT2504, HT2505, HT2507, HT9088, HT9091, Exp 04/10; Lot HX3277, HX3279, Exp 07/10; Lot HZ1372, HZ1373, Exp 09/10; Lot JC1147, Exp 11/10;

46) Lot HM2678, HM2679, HM2738, HM2739, HM2740, HM2744, HM8935, HL1700, HL6593, HM2596, HM2603, HM8908, HM2648, HM2661, HM8923, HL1685, HL6611, HL6612, HL6613, HL6614, HL6615, HM2600, HM2606, HM9135, Exp 09/09; Lot HN4931, HN4932, HN4933, HN8236, HN8241, HP4303, HM8911, HM8912, HM8914, HM8915, HM8916, HM8917, HN4906, HN4909, HM8925, HM8926, HM8927, HN4900, HN4902, HN4908, HN4913, HN8227, HN8229, HM9133, HM9136, HM9137, HM9140, HM9143, HM9146, HN4901, HN4903, HN4904, HN4905, HN4907, HN4911, HN4914, HT0236, Exp 10/09; Lot HN8242, HN8244, HP4272, HN4912, HN8200, HN8201, HN8202, HP4230, HP4231, HN8231, Exp 11/09; Lot HN8225, Exp 01/10; Lot HV1283, HV6382, HV1518, HV1519, Exp 04/10; Lot HX3200, Exp 06/10; Lot HZ8957, HZ8844, Exp 10/10, Lot JA3872, JA3873, JA3875, JA3877, Exp 11/10.

47) Lot HN2920, HN2921, HN2923, HM7299, Exp 09/09; Lot HN2922, HN2884, HN2885, HN2896, Exp 10/09;

48)  Lot HM9055, HM9089, HM9091, HM9094, HM9098, HM9101, HM9103, HM9104, HM9106, HM9109, HM9111, HL0403, HN0209, HN1729, HN1730, HN4834, HN4835, HN4836, HN4837, HN4838, Exp 09/09; Lot HM2310, HM2312, HN2714, HN2716, HN2719, HN5744, HN2738, HN2740, HN2742, HN2745, HN2764, HN2765, HN2768, HN2769, Exp 10/09; Lot HY0224, Exp 07/10; Lot HY8533, Exp 08/10; Lot JA7704, JC3169, JC3170, JC3171, JC3172, JC3173, JC3179, Exp 12/10; Lot JC9009, Exp 01/11;

49) Lot HZ8679, Exp 04/10; Lot HM9682, Exp 07/10; Lot HZ8683, HZ2532, HZ2537, HN4407, JF2233, Exp 08/10; Lot JE8761, Exp 12/10; Lot JE0778, Exp 02/11;

50) Lot JE1347, Exp 02/11;

51) Lot HZ9836, HZ9837, Exp 11/10;

52) Lot HP0785, HP0787, HP0788, Exp 10/09; Lot JD0237, JD0240, HD0242, Exp 02/11;

53) Lot HY6616, HY6617, HY6618, Exp 03/10;

54) Lot JE7419, 05/11;

55)  Lot JG0671, Exp 07/11;

56) Lot HY6631, Exp 09/10; Lot JE1950, JE5040, JE5041, JE5042, JE1712, Exp 04/11;

57) Lot HL2342, HV2631, Exp 09/09; Lot HX6621, Exp 01/10; Lot HY4713, Exp 02/10; Lot HX6623, Exp 07/10; Lot HY4714, Exp 08/10; Lot JD7363, Exp 09/10; Lot JD7362, Exp 03/11; 

58) Lot HN1767, Exp 09/09; Lot HR1725, HR1737, Exp 01/10; Lot HR5819, Exp 02/10; Lot HV2607, Exp 03/10; Lot HY4721, HY4722, Exp 08/10; Lot HZ9653, Exp 11/10; Lot JD7365, JE3899, Exp 03/11;

59) Lot HR1756, HR1758, Exp 01/10; Lot HR5838, Exp 02/10; Lot HV2570, Exp 03/10; Lot HX6618, HX6614, Exp 07/10; Lot HY4738, Exp 08/10; Lot HY4735, HY4743, Exp 09/10; Lot HZ9652, Exp 11/10; Lot JD7367, Exp 03/11;

60) Lot JA7369, Exp 11/09; Lot JD7357, Exp 03/10;

61) Lot HN1454, HN1457, Exp 11/09; Lot HN8607, HN8609, HP3260, HP8075, HP8076, HP8077, HP8078, HP8121, HP8122, HP8129, Exp 12/09; Lot HT1187, HT1188, HT1189, HT1190, HT1191, HT1192, Lot HT1196, HT1193, HT1194, HT1197, HT1198, HX5447, HT1199, Exp 02/10; Lot HW9319, Exp 04/10; Lot JC2357, JC2342, Exp 12/10;

62) Lot HM5292, Exp 10/09; Lot HP8185, HR7929, HP8182, HP8186, HP8187, HP8184, Exp 12/09; Lot HV3655, Exp 04/10; Lot HY9984, HY6727, HY9915, Exp 08/10;

63) Lot HT1457, Exp 09/09; Lot HV7807, Exp 11/09; Lot HW5805, HX0575, Exp 12/09; Lot HX7978, Exp 01/10; Lot HX7973, Exp 02/10; Lot HY7604, HY7606, HY7607, Exp 03/10; Lot HZ2508, HZ2510, Exp 04/10; Lot JA0934, JA0936, JA0938, Exp 05/10; Lot JC1560, JC1561, JC1562, JG1019, Exp 07/10; Lot JC7120, JC7121, JC7122, JD3690, Exp 08/10; Lot JD3692, JD9640, Exp 09/10; JD9641, JE6128, Exp 10/10; Lot JE6129, Exp 11/10;

64) Lot JA6687, Exp12/10; Lot JC8845, Exp 02/11;

65) Lot JE4290, Exp 04/11;

66) Lot HT4487, Exp 03/10;

67) Lot JA6764, HZ9217, HZ9219, JA6770, Exp 11/10; Lot JA6772, JC5493, Exp 12/10;

68) Lot HZ9127, Exp 10/10; Lot HZ9124, JA7690, JA7701, JA7746, Exp 11/10; Lot JD8931, JD8918, JD8922, JD8925, Exp 03/11;

69) Lot HZ9119, HZ9121, Exp 10/10;

70) Lot HM5165, HN7005, Exp 09/09; Lot HM0459, Exp 11/09; Lot HT4880, Exp 04/10;

71) Lot HP0802, Exp 09/09; Lot HT7555, HW3500, HW5764, HT7557, Exp 03/10; Lot JD0244, Exp 02/11;

72) Lot HX3598, HT8883, Exp 03/10;

73) Lot HY2910, HY2912, Exp 08/10; Lot JC7926, JD7894, Exp 02/11; Lot JE0940, JE6056, Exp 04/11
RECALLING FIRM/MANUFACTURER
Apotex Inc., Ontario, Canada, b
REASON
CGMP Deviations: products manufactured in a facility with significant cGMP deficiencies.
VOLUME OF PRODUCT IN COMMERCE
4,578,203 bottles and boxes
DISTRIBUTION Nationwide

PRODUCT PREMPRO"(conjugated estrogens/medroxyprogesterone acetate tablets) 0.3 mg/1.5 mg, Rx only. One carton contains 3 EZ-DIAL Dispensers of 28 tablets each. NDC 0046-0938-09, One EZ-DIAL Dispenser contains 28 cream PREMPRO Tablets containing 0.3 mg of the conjugated estrogens found in PREMARIN & 1.5 mg of medroxyprogesterone acetate. 
CODE Lot C18404, exp. March 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Inc., Philadelphia, PA,
Manufacturers: Wyeth Pharmaceuticals, Inc., Rouses Point, NY, and Wyeth Pharmaceuticals, Co., Guayama, PR. 
REASON
Failed Dissolution Specification; 9-month test interval.
VOLUME OF PRODUCT IN COMMERCE
24,360 cartons of 3 dispensers
DISTRIBUTION Nationwide

PRODUCT 
1) YAZ (Drospirenone & Ethinyl Estradiol); Rx only; 3.0 mg drospirenone &0.02 mg ethinyl estradiol; 3 x 28 tablets- blister packages 24 active and 4 placebo, NDC 50419-405-03. 

2) Ocella (drospirenone and ethinyl estradiol tablets) 3 mg/0.3 mg, Rx only;This package contains one blister of 28 tablets: 21 yellow tablets, containing 3 mg of drospirenone and 0.3 mg of ethinyl estradiol; and seven white inert tablets', NDC 0555-9131-767. 
CODE
1) Lot 91605A, Exp 12/2013;
2) Lot number 84080A, Exp 12/2011; lot number 84081A, Exp. 12.2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer HealthCare Pharmaceuticals, Inc., Wayne, NJ
Manufacturer: Schering Gmbh Und Co. Produktio, Weimar, Germany. 
REASON
CGMP Deviations:Out of Specification analytical value for chemical assays of drospirenone and ethinyl estradiol was averaged with another analytical value to provide a reported result that was within specification.
VOLUME OF PRODUCT IN COMMERCE
1) 32,856 boxes (3 blister packages/box);
2) 122,208 boxes (3 blister packages/box)
DISTRIBUTION Nationwide

PRODUCT Loratadine Oral Solution, 5 mg per 5 mL, Fruit Flavored Syrup, 120 mL bottle (4 fl oz), OTC, NDC 54838-538-40 (SILARX label); and Clear-Atadine (loratadine) Oral Solution, 5 mg per 5 mL, Fruit Flavored Syrup, 120 mL bottle (4 fl oz), OTC, NDC 0904-5727-20 (MAJOR label). 
CODE
(Silarx label): Control #s 5557A (Exp 3/11); 5573A, 5574A, 5576A, 5578A (Exp 4/11); (Major label): Control # 5579A (Exp 4/11) ; RECALL EXPANSION: NDC 54838-538-40 (Silarx label): Control #s 5537A , 5538A , 5539A , 5540A, 5541A, 5554A, 5555A, 5556A (Exp 3/11); 5570A, 5571A, 5572A, 5575A, 5577A (Exp 4/11); 5593A, 5594A, 5595A, 5596A, 5597A (Exp 5/11); 5626A, 5627A, 5628A, 5629A, 5630A, 5631A (Exp 6/11); (Major label): Control #s 5553A (Exp 3/11); 5598A (Exp 5/11); 5632A, 5633A (Exp 6/11)
RECALLING FIRM/MANUFACTURER
Silarx Pharmaceuticals, Inc., Spring Valley, NY, 
REASON
Presence of Particulate Matter: The manufacturer received several complaints of cloudiness (particulates) in Loratadine Oral Solution. The firm's investigation concluded that the cloudiness was due to EDTA, an inactive ingredient in the OTC drug product.
VOLUME OF PRODUCT IN COMMERCE
280,357 bottles
DISTRIBUTION Nationwide

WEEK ENDING NOVEMBER 21

PRODUCT 
1) Brompheniramine Phenylephrine Tannate Suspension, each 5mL (one teaspoonful) contains Phenylephrine Tannate, 20 mg and Brompheniramine Tannate, 12 mg., 16 fl. oz. (473 mL), Rx only, NDC 62559-6331-6. 

2) Brompheniramine Tannate Suspension, 12 mg per 5mL, 4 fl. oz. (473 mL), Rx only,  NDC 62559-6291-4. 
CODE
1) FBP010, Exp 07/10 UPC: N 3 62559 63316 1;

2) Lot Nos.: FBS001, exp. 03/10; FBS002, exp.09/10, HBS001, exp. 01/11; HBS002, exp. 06/11 UPC: N 3 62559 62914 0
RECALLING FIRM/MANUFACTURER
ANIP Acquisition Co., Gulfport, MS,
REASON
Unapproved New Drug.
VOLUME OF PRODUCT IN COMMERCE
17,892 units
DISTRIBUTION Nationwide

PRODUCT 
1) CitruShield, Barrier Lotion, 8 fl oz bottle, "Helps Clean, Protect, Heal, and Disinfect", UPC 689076501330. 

2) Total SkinCare Work, Skin Protection & Safety, 8 fl oz, "Helps heal and repair skin damage, Helps stop bleeding" Benzalkonium Chloride, UPC 12583060277. 

3) Iron Fist, Barrier Hand Treatment, 2.5 fl oz (75 mL), Kills Germs, Clinically Proven to Kill 99.9% of Germs on Contact, Keeps Killing For Hours, Benzalkonium (0.05%), UPC 894705002045. 

4) Skin Shield Restaurant, 8 fl oz, Benzalkonium chloride, Invisible Glove: Also protects, cleans, repairs, and disinfects the skin, Made exclusively by Clarcon, UPC 689076501330.

5) Skin Shield Industrial, 8 fl oz, Benzalkonium chloride, Also protects, cleans, repairs, and disinfects the skin, Made exclusively by Clarcon, UPC 689076501330. 

6) Skin Shield Beauty Salon, 8 fl oz, Benzalkonium chloride, Also protects, cleans, repairs, and disinfects the skin, Made exclusively by Clarcon, UPC 689076501330. 
CODE No lot numbers or codes
RECALLING FIRM/MANUFACTURER
Clarcon Biological Chemistry Laboratory Inc., Roy, UT, 
REASON
Antimicrobial skin sanitizers and hand protectant products may contain high levels of bacteria.
VOLUME OF PRODUCT IN COMMERCE
34,700 bottles (Domestic), 8000 bottles (Mexico)
DISTRIBUTION MD, UT, Mexico

PRODUCT  Oxazepam Capsules 15 mg, 500 count bottles. Rx only, NDC 0172-4805-70. 
CODE Lot number: BEG72A exp 11/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, 
Manufacturer: Ivax Pharmaceuticals Ireland, Waterford, Ireland. 
REASON
Presence of foreign tablet; some bottles may contain 10 mg capsules.
VOLUME OF PRODUCT IN COMMERCE
1302 bottles
DISTRIBUTION AZ, CA, FL, GA, KS, LA, MA, NC, NM, NV, OH, PA, SC, TN, and TX

PRODUCT  SOTRET (isotretinoin) Capsules, USP, 40 mg, 30 count per carton (3 x 10 capsule Prescription Packs; NDC 10631-586-31. 
CODE Lot # 1927440, Exp 06/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ranbaxy, Inc., Princeton, NJ, 
Manufacturer: Ranbaxy Laboratories, Limited, Simour District, India.
REASON
Impurities/Degradation Products: Out of Specification results for methylparaben and butylated hydroxyanisole (BHA) for one lot of SOTRET (isotretinoin) Capsules, 40 mg.
VOLUME OF PRODUCT IN COMMERCE
4,348 cartons
DISTRIBUTION Nationwide

PRODUCT 
1) Complete-RF Prenatal, Prenatal Multivitamin/Multimineral Tablets, 90 tablets, Rx only, NDC 13811-008-90. 

2) Trinatal Rx1 (one tablet daily), Prenatal Multivitamin/multimineral Tablet, Rx only, NDC: 13811-007-10, 100 Tablets. 
CODE
1) Lot # 86264, Exp 4/2011;
2) Lot # 86265, Exp. 5/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: TRIGEN Laboratories, Inc., Sayreville, NJ, 
Manufacturer: Phoenix Labs Rising LLC, Farmingdale, NY. 
REASON
Tablet printed with incorrect ID; The imprint coding on the tablets of Trinatal Rx1 vitamins are incorrectly identified as Complete - RF Prenatal vitamins.
VOLUME OF PRODUCT IN COMMERCE
1) 617 bottles; 2) 133 bottles 
DISTRIBUTION Nationwide

PRODUCT  Advanced Listerine with Tartar Protection (eucalyptol 0.092%, menthol 0.042%, methyl salicylate 0.060%, thymol 0.064%), Antiseptic, Arctic Mint, 500 ml bottles, UPC number 312547429252. Item number 42925. CODE Lot number 1749LZ exp 5/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Johnson & Johnson Consumer Group of Companies, Inc., Skillman, NJ, 
Manufacturer: McNeil PPC, Inc., Lititz, PA. 
REASON
Mislabeled - incorrect back label.
VOLUME OF PRODUCT IN COMMERCE
1000 bottles
DISTRIBUTION Nationwide

P&G Recalls Specific Lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom

The Procter & Gamble Company (NYSE:PG) is recalling three lots of its Vicks Sinex nasal spray in three countries:  the United States, Germany and the United Kingdom.

The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany.  

These three lots were sold only in the United States, Germany and the United Kingdom

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries.  P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

The lot numbers of the products involved are:

This lot number is listed on both the outer carton and the bottle.  Consumers should simply discard the affected product as they would any OTC medicine.

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries.  P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

Anyone who has these specific lots of this product can call P&G for a replacement coupon or refund at the following numbers:

From the United States, please call:  1.877.876.7881 (Hours of operation:  Monday - Friday, 9AM - 6PM US ET, Saturday - Sunday, 9AM - 4PM US ET)

From the United Kingdom, please call:  0800.5555.15 (Hours of operation:  19 November, 4PM - 9PM local time and will continue Monday - Friday, 8AM - 6PM local time, Saturday - Sunday, 9AM - 5PM local time)

From Germany, please call:  0800.111.6131 (Hours of operation:  19 November, 4PM - 9PM local time and will continue Monday - Friday, 8AM - 6PM local time, Saturday - Sunday, 9AM - 5PM local time)

WEEK ENDING NOVEMBER 14

GMP Herbal Products, Inc. Issues a Recall of a Weight Loss Supplement Found to Contain Undeclared Drug Ingredients 

GMP Herbal Products, Inc. is recalling Pai You Guo, a weight loss dietary supplement, sold and marketed by the firm because it contains undeclared drug ingredients.  All lots of the following Pai You Guo product are being recalled. The product is sold either in a box of 30 capsules or a bag of 10 g powder.

The products listed above were sold and distributed nationwide via the internet.

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

Consumers with questions may contact GMP Herbal Products, Inc Tuesday through Saturday 11:00 am to 7:00 pm at 1-866-995-8585.  

IDS Sports Conducts a Recall of Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR

IDS Sports is recalling five of the company’s dietary supplement products sold under the following names: Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and Ripped Tabs TR.

The recalled products contain the following undeclared substances, which FDA considers to be steroids: “Madol,” “Turinabol,” “Superdrol,” and/or “Androstenedione.”

The recalled products listed below were distributed in either black boxes containing blister packs of 60 capsules or white bottles with black labels containing 30 or 60 capsules.

RockHard Laboratories Issues A Recall of Specific Lots of RockHard Weekend Marketed as Dietary Supplement 

RockHard Laboratories is recalling the company’s dietary supplement sold under the name RockHard Weekend (RHW) specific to the following Lot Numbers:

Blister Pack: T12 705 08 (exp: 10/11) / T12 705 09 (exp: 3/12, 8/12)
3ct Bottle: R417 0509 (exp: 09/12)
8ct Bottle: T237-0509 (exp: 06/12)

RockHard Laboratories is conducting a recall because lab analysis found that RHW, specific to the above lot numbers, contains sulfoaildenfil, an analogue of Sildenfil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making RockHard Weekend an unapproved drug. The active drug ingredient is not listed on the product label.

RHW is sold nationwide in single blisters, 3-count and 8-count bottles. RockHard Laboratories advises any customers in possession of RHW to return any unused product for a full refund to the company directly. 

Customers can call 1.800.562.0543 for instructions on the return and refund process.

PRODUCT INVEGA (paliperidone) Extended-Release Tablets, 6 mg, 30-count bottle, Rx only, NDC 50458-551-01. 

CODE Lot # 9KG024, Exp 11/10

Recalling Firm: Global Supply Pharmaceutical Gr, Titusville, NJ,

Manufacturer: Janssen Cilag Manufacturing LLC, Gurabo, PR. 

CGMP Deviations: One lot of INVEGA 6 mg was coated pink, when the approved color for the 6 mg tablets is beige.

19,668 bottles

DISTRIBUTION Nationwide

PRODUCT Twinject 0.3 mg Auto-Injector (epinephrine injection, USP 1:1000), Rx only, NDC 59630-802-01. Note that this lot of Twinject is labeled with the previous owner, Verus Pharmaceuticals', NDC # 13436-700-01. 

CODE Lot U081008A

Recalling Firm: Sciele Pharma, Inc., Atlanta, GA, 

Manufacturer: Philips Plastics, Corp., Menomonie, WI. F

Defective Delivery System; High Force-To-Fire values for the 12 month pull performance testing of Twinject 2008 annual stability units.

5,988 units

DISTRIBUTION AZ, CA, CO, CT, FL, LA, NC, OH, PA, SC, TX, WA, and WI

PRODUCT EXE-FEN - IR, DECONGESTANT - ANTIHISTAMINIC, IMMEDIATE RELEASE TABLETS, Pseudoephedrine HCl 60mg, Guaifenesin 400mg, 100 count bottles, Rx only. 

CODE Lot# 091138, Exp. 07/31/2011

Recalling Firm: Larken Laboratories, Inc., Canton, MI, 

Manufacturer: Contract Pharmacal Corp., Hauppauge NY. F

Label Mix Up - Product is incorrectly labeled as a decongestant - antihistaminic, but should be labeled as decongestant - expectorant.

384 units

DISTRIBUTION Nationwide

WEEK ENDING NOVEMBER 7

Hospira Issues Recall of Certain Lots of Liposyn™ and Propofol Products That May Contain Particulate Matter 

Hospira, Inc. (NYSE: HSP), a global specialty pharmaceutical and medication delivery company, is recalling 85 lots of Liposyn^™ II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, Liposyn III 30% and 73 lots of Propofol Injectable Emulsion 1% products that begin with the lot numbers 79 and 80 because some of the containers may contain particulate matter. The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process. The affected lots were distributed between July 2009 and October 2009, and no other lots are affected by this recall.

Anyone with an existing inventory should quarantine the product immediately and call Stericycle at 1-866-654-0725 to arrange for the return of these products. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187 between 8 a.m. and 5 p.m. CST, Monday through Friday.

Hospira is currently manufacturing both products and has begun to ship replacement product.  Please contact Hospira Customer Care at 1-877-946-7747 for further details.

PRODUCT Pure & Klean Hand Sanitizer (Isopropyl Alcohol 65%), packaged in 10 fl. oz. (296 ml) bottles, Kills 99.99% of Germs, Moisturizes with Vitamin E, also labeled as: Klean Hands Hand Sanitizer and Guaynabo City Hand Sanitizer. 
CODE All lots
RECALLING FIRM/MANUFACTURER
Universal Manufacturing Corp., Vega Alta, PR, 
REASON GMP Deviations
VOLUME OF PRODUCT IN COMMERCE
24,595 bottles
DISTRIBUTION PR

PRODUCT 
1)  Clonazepam Tablets, USP, 0.5 mg in 100 count bottles (NDC 0093-0832-01 - shipped 120 bottles per case) and 500 count bottles (NDC 0093-0832-05 - shipped 72 bottles per case), Rx Only. 

2) Clonazepam Tablets 1.0 mg in 100 count bottles (NDC 0093-0833-01 - shipped 144 bottles per case), 500 count bottles (NDC 0093-0833-05 - shipped 48 bottles per case) and 1000 count bottles (NDC 0093-0833-10 - shipped 36 bottles per case), Rx Only. 
CODE
1) Lot numbers: 35200435A exp 9/2010, 35200408A exp 9/2010, 35200409A exp 9/2010, 35200436A exp 9/2010, 35200437A exp 9/2010, 35200460A exp 9/2010, 35200462A exp 9/2010, and 35200438A exp 9/2010;

2) Lot numbers: 35200199A exp 2/2010, 35200200A exp 2/2010, 35200201A exp 2/2010, 35200218A exp 2/2010, 35200219A exp 2/2010, 35200278A exp 2/2010, 35200202A exp 2/2010, 35200248A exp 2/2010, 35200220A exp 2/2010 and 35200203A exp 2/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, .
Manufacturer: Novopharm Ltd., Scarborough, Ontario, Canada. F
REASON
Tablets may exceed specifications for weight, thickness and potency.
VOLUME OF PRODUCT IN COMMERCE
870,531 bottles
DISTRIBUTION Nationwide

PRODUCT 
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), 100 mg Single Use Vial, For IV Use only, Sterile lyophilized Suspension, Rx Only, NDC 68817-134-50 --- Australian label: Abraxane 100 mg Nanoparticle albumin-bound paclitaxel powder for injection (suspension) For Intravenous Use Only, PRESCRIPTION ONLY MEDICINE --- Each vial contains: paclitaxel 100 mg, Human Albumin 900 mg --- Abraxis BioScience LLC Distributed in Australia. 
CODE
Lots 406580 (exp. 6/30/2010), 407545 (exp. 6/30/2010), 406427 (exp 9/30/2010), 406453 (exp. (9/30/2010), 406617 (exp. 10/31/2010), 407150 (exp. 2/28/2011). Product Code 103450 and AU103450 (Australia)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abraxis Bioscience LLC dba Abraxis Oncology, Los Angeles, CA, 
Manufacturer: APP Pharmaceuticals, LLC, Grand Island, NY.
REASON
Presence of Particulate Matter.
VOLUME OF PRODUCT IN COMMERCE
13,455 units (commercial) and 4,732 units (clinical use)
DISTRIBUTION Nationwide, PR and Australia

American Regent Expands Recall to Include All Lots of Ketorolac Tromethamine Injection, USP 15 mg/mL; 1mL Single Dose Vials 

American Regent is recallng ALL lots of its Ketorolac Tromethamine Injection, USP 15 mg/mL:

NDC# 0517-0601-25 15 mg/mL 1mL Single Dose Vial

PLEASE NOTE: This recall is in addition to the recall initiated on October 16, 2009 when American Regent recalled ALL unexpired lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL due to the presence of particulate matter in conjunction with crystallization.

This recall is due to the potential that particulates from crystallization may be present in the product. 

The product was distributed to wholesalers and distributors nationwide.

Hospitals, surgi-centers, clinics and other healthcare facilities should not use any AMERICAN REGENT Ketorolac Tromethamine Injection, USP Injection 15 mg/mL for patient care and should immediately quarantine any product for return.

American Regent will credit accounts for all returned Ketorolac Tromethamine Injection, USP product. Those with questions about the return process, please call our Customer Service Department at 1-800-645-1706: Monday thru Friday from 8:30 AM to 7:00 PM ET.

Hospitals, surgi-centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 631-924-4000.

BODYBUILDING.COM Is Conducting a Recall of 65 Dietary Supplements That May Contain Steroids 

Bodybuilding.com, LLC (the “Company") is recalling of all lots and expiration dates of 65 dietary supplement products (the "Recalled Products") described on the attached list, that were sold through the Company's website, www.bodybuilding.com.

The Recalled Products may contain the following ingredients that are currently classified, or should be classified, as steroids: "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol."

Customers who have any of the Recalled Products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking one or more of the ingredients listed above.

Consumers should return any unused products purchased on the Company’s site to the Company. For instructions on how to return Recalled Products please call (1-866-236-8417) or e-mail (service@bodybuilding.com) the Company.

RECALLED PRODUCT LIST 

Brand Name

4Ever Fit D-Drol

Advanced Muscle Science Dienedrone

Advanced Muscle Science Liquidrone UTT

Anabolic Xtreme Hyperdrol X2

APS (aka Advanced Muscle Science) Mastavol

APS (aka Advanced Muscle Science) Revamp

APS (aka Advanced Muscle Science) Ultra Mass Stack

APS (aka Advanced Muscle Science) Ripped Stack

Better Body Sports Finadex

Black China Labs Straight Drol

Black China Labs Straight Phlexed

Body Conditioning Solutions TestraFLEX

Bjorklund Methyldrostanolone

BOSC Enterprises Epi-Tren

BOSC Enterprises Magna Drol

Chaparral Labs Epivol

Chaparral Labs Pheravol-V

Competitive Edge Labs M-Drol

Competitive Edge Labs P-Plex

Competitive Edge Labs X-tren

Diabolic Labs Epio-Plex

Diabolic Labs Finabolic 50

Diabolic Labs Revenge 

Ergopharm 6-OXO 

Ergopharm 6-OXO Extreme 

EST (aka Engineered Sports Technology) MethAnstance 

Extreme Labs Susto-Test Depot 

Fizogen ON Cycle II Hardcore 

G.E.T/ (Genetic Edge Technologies) SUS-500 

G.E.T/ (Genetic Edge Technologies) Tren-250 

Hardcore Formulations T-Roid 

I Force Nutrition 1,4 AD Bold 200 

I Force Dymethazine/Reversitol Combo Pack 

I Force Reversitol 

I Force Nutrition 17a PheraFLEX 

I Force Nutrition Dymethazine 

I Force Nutrition Methadrol 

IDS (aka Innovative Delivery Systems) Bromodrol 

IDS (aka Innovative Delivery Systems) Grow Tabs TR 

IDS (aka Innovative Delivery Systems) Mass Tabs 

IDS (aka Innovative Delivery Systems) Oxodrol Pro 

IDS (aka Innovative Delivery Systems) Ripped Tabs TR 

IDS (aka Innovative Delivery Systems) Rapid Release 

Ripped Tabs 

Kilo Sports Massdrol 

Kilo Sports Phera-Mass 

Kilo Sports Trenadrol 

Monster Caps Monster Caps 

Myogenix Spawn 

Nutra Coastal D-Stianozol 

Nutra Coastal H-Drol 

Nutra Coastal MDIT 

Nutra Coastal S-Drol 

Nutra Coastal Trena 

Performance Anabolics Methastadrol 

Performance Anabolics Tri-Methyl X 

Purus Labs E-pol Inslinsified 

Purus Labs Nasty Mass 

Rage RV2 

Rage RV3 

Rage RV4 

Rage RV5 

Redefine Nutrition Finaflex 550-XD 

Redefine Nutrition Finaflex Ripped 

Transform Supplements Forged Extreme Mass 

Transform Supplements Forged Lean Mass