OCTOBER 2009

OCTOBER 2009

WEEK ENDING OCTOBER 31

Pointe Scientific, Inc Expands Recall of Liquid Glucose Hexokinase Reagent (G7517)

Pointe Scientific, Inc, Canton, MI is recalling all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range.

Distributors and testing laboratories who have received the Pointe Scientific, Inc Liquid Glucose Hexokinase Reagent (G7517) which is being recalled should destroy remaining inventory.

The recall includes the following lot numbers:

Lot # 823901 (all batches)     Expiration: 2010-02
Lot # 826801 (all batches)     Expiration: 2010-03
Lot # 829401 (all batches)     Expiration: 2010-04
Lot # 831502 (all batches)     Expiration: 2010-05

Catalog #s: G7517-120 (97 kits), G7517-500(129 kits), G7517-1L (31), 8-G7517-120 (15 vials), 8-G7517-500 (21vials), 3-G7517-L (28L), 7-G7517-500 (5 vials). 7-G7517-1000 (3bottles)

Lot #814301 (all batches) Expiration: 2009-11
Lot# 820502 (all batches) Expiration: 2010-01

Catalog # s of these lots all begin with G7517and the quantities are yet to be determined.

The Pointe Scientific, Inc Liquid Glucose Hexokinase Reagent (G7517) was distributed to medical device distributors and/or drop-shipped to testing laboratories nationwide by courier delivery service. Product involved in the recall can be identified by any of the lot numbers listed above appearing on the Pointe Scientific, Inc kit content label, vial label or bulk container label.

Pointe Scientific, Inc has notified its distributors and drop-ship customers by e-mail, fax, telephone and/or certified mail and is arranging for replacement of all recalled products.

Distributors and testing laboratories with questions may contact the company at 1-800-445-9853.

Pointe Scientific, Inc Issues Recall of Liquid Glucose Hexokinase Reagent (G7517)

Pointe Scientific, Inc, Canton, MI is recalling of all size kits of Liquid Glucose Hexokinase Reagent catalog number G7517. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range.

Distributors and testing laboratories who have received the Pointe Scientific, Inc Liquid Glucose Hexokinase Reagent (G7517) which is being recalled should destroy remaining inventory.

The recall includes the following lot numbers:

Lot # 823901 (all batches) Expiration: 2010-02

Lot # 826801 (all batches) Expiration: 2010-03

Lot # 829401 (all batches) Expiration: 2010-04

Lot # 831502 (all batches) Expiration: 2010-05

Catalog #s: G7517-120 (97 kits), G7517-500(129 kits), G7517-1L (31), 8-G7517-120 (15 vials), 8-G7517-500 (21vials), 3-G7517-L (28L), 7-G7517-500 (5 vials). 7-G7517-1000 (3bottles)

Pointe Scientific, Inc has notified its distributors and drop-ship customers by e-mail, fax, telephone and/or certified mail and is arranging for replacement of all recalled products.

Distributors and testing laboratories with questions may contact the company at 1-800-445-9853.

PRODUCT Temodar (temozolomide) capsules, 5 mg, 5-count bottles, Rx only; NDC 0085-3004-02.
CODE Lot # 7HLO009, Exp 09/10
RECALLING FIRM/MANUFACTURER
Schering-Plough Products, LLC, Las Piedras, PR,
REASON
Impurities/Degradation Products: This product is being recalled because of an out of specification (OOS) stability result obtained for moisture and total degradation products.
VOLUME OF PRODUCT IN COMMERCE
13,141 bottles
DISTRIBUTION Nationwide

PRODUCT
1) M.V.I. ADULT (Multi-Vitamin Infusion), 10 mL UNIT VIAL, 10 Unit Vials of 10 mL each to be used as a single dose per carton, Rx only; NDC 61703-422-81.

2) M.V.I.-12 (Multi-Vitamin Infusion Without Vitamin K), 10 mL UNIT VIAL, 10 Unit Vials of 10 mL each to be used as a single dose per carton, Rx only; NDC 61703-423-81.
CODE
1) Lot # 8132A, 8133A, Exp 09/09; Lot # 8134A, Exp 10/09; Lot # 8135A, 8136A, 8139A, exp 11/09; Lot # 8140A, 8141A, 8142A, 8143A, Exp 12/09; Lot # 8144A, 8145A, Exp 01/10; Lot # 8146A, 8148A, 8149A, Exp 02/10; Lot # 8150A, 8151A, 9013A, Exp 03/10; Lot # 9014A, 9015A, 9018A, Exp 04/10; Lot # 9019A, 9020A, 9021A, Exp 05/10; Lot # 9022A, 9023A, Exp 06/10;

2) Lot # 8130A, 8131A, 8137A, Exp 10/09; Lot # 8138A, 8147A, Exp 01/10; Lot # 9016A, 9017A, Exp 04/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL,
Manufacturer: AstraZeneca LP, Westborough, MA.
REASON
Subpotent (Multiple Ingredient Drug): The discolored top chamber solution does not meet the visual appearance specification. This discoloration potentially impacts the potency of the Biotin and Folic Acid contained in the top chamber.
VOLUME OF PRODUCT IN COMMERCE
1,862,420 vials
DISTRIBUTION Nationwide

PRODUCT OPANA ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 10 mg, 100 count bottles, Rx Only; NDC 63481-674-70.
CODE Lot 401445NV
RECALLING FIRM/MANUFACTURER
Recalling Firm: Endo Pharmaceutical, Inc., Westbury, NY,
Manufacturer: Novartis Consumer Health, Lincoln, NB.
REASON
Mislabeled; Bottles labeled as 10 mg tablets actually contain 5 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
8,170 bottles
DISTRIBUTION Nationwide

PRODUCT Fentanyl Transdermal System 75 mcg/hr, 5 systems per box, Rx only; NDC 0093-6902-19.
CODE Lot number 37649 exp 9/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA,
Manufacturer: AVEVA Drug Delivery Systems, Inc., Miramar, FL.
REASON
Incorrect NDC bar code label on the outer carton; bar code is indicated for the 100 mcg/hr strength instead of the 75 mcg/hr strength. The immediate package label is correct.
VOLUME OF PRODUCT IN COMMERCE
31,968 cartons
DISTRIBUTION Nationwide

PRODUCT SUSPENDOL-S Compounding Vehicle, NDC 0574-0307-16, Net Contents 473 mL (one pint).
CODE Lot number on bottle 8485024. The bottle label omits the first three digits "200" from the lot number. SAP Lot Number 2008485024.
RECALLING FIRM/MANUFACTURER
Paddock Laboratories, Inc., Minneapolis, MN,
REASON
Presence of Foreign Substance; due to the presence of a food grade lubricant, (Super Lube, Multipurpose Synthetic Lubricant with Syncolon) was found.
VOLUME OF PRODUCT IN COMMERCE
766 bottles
DISTRIBUTION Nationwide

PRODUCT ALLOPURINOL Tablets, USP, 100 mg, 30 Tablets, Rx only; NDC16714-142-01.
CODE Lot No. 61008, EXP 10/10
RECALLING FIRM/MANUFACTURER
Rx PAK, Memphis, TN,
REASON
Labeling: Correct Labeled Product Mispack; 100 mg bottles packed in shipping boxes labeled as 300 mg.
VOLUME OF PRODUCT IN COMMERCE
41 cases of 12 units
DISTRIBUTION Nationwide

PRODUCT Desmopressin Acetate Injection 4 mcg/ml, Each mL provides: Desmopressin acetate 4 mcg, Chlorobutanol 5 mg, Sodium chloride 9 mg, For IV or SC use 1 mL Preserved Vial, Rx only; NDC (single vials) 0703-5051-01; NDC (package of 10 vials) 0703-5051-03. CODE
Lot numbers 31305212B exp 12/2010; 31306384B exp 3/2011; 31306687B exp 3/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA,
Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA.
REASON
Failed pH Specification; 6 month stability.
VOLUME OF PRODUCT IN COMMERCE
156,080 vials
DISTRIBUTION Nationwide

WEEK ENDING OCTOBER 24

PRODUCT Cyclosporine Capsules USP, 100 mg, 30 Capsules Rx Only, APOTEX CORP., NDC 60505-0134-0.
CODE Lot HM4156
RECALLING FIRM/MANUFACTURER
Apotex Inc., Etobicoke Ontario, Canada,
REASON
Exceeds Impurity Specification; for unknown related compounds 12 month stability.
VOLUME OF PRODUCT IN COMMERCE
19,794
DISTRIBUTION Nationwide

PRODUCT
1) Fexofenadine Hydrochloride Tablets, 180 mg, 500 count bottle, Rx only, NDC 55111-194-05.

2) Pravastatin Sodium Tablets USP, 10 mg, 90 count bottles, NDC 55111-229-90, 500 count bottles, NDC 55111-229-05, Rx only.

3) Risperidone Tablets USP, 0.25 mg, 500 count bottles, Rx only, NDC 55111-201-05.

4) Citalopram Tablets USP, 40 mg, 100 count bottles, Rx only, NDC 55111-344-01.
CODE
1) Lot # C90833, Exp 03/11;
2) Lot # C92476, Exp 09/10;
3) Lot # C92847, Exp 04/11;
4) Lot # C90995, Exp 01/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dr Reddy'S Laboratories Inc., Bridgewater, NJ,
Manufacturer: Dr. Reddy's Laboratories Ltd., Andhra Pradesh, India.
REASON
Superpotent (Single Ingredient) Drug, Tablet Thickness: Firm received complaints of double-sized tablets.
VOLUME OF PRODUCT IN COMMERCE
23,735 bottles
DISTRIBUTION Nationwide

PRODUCT Claritin, (loratadine) Tablets 10 mg/ Antihistamine, 5 tablets per package, Non-Drowsy, Item Number 80317-15; Case UPC number 100-41100-80317-4. CODE Lot number 8G16AR; Exp. Date 9/30/2011
RECALLING FIRM/MANUFACTURER
Schering Corp., Kenilworth, NJ,
REASON
Incorrect Expiration Date; product labeled with a 42-month expiration date (09/30/2011) instead of a 30-month expiration date (09/30/2010) on both the outer carton and individual blisters.
VOLUME OF PRODUCT IN COMMERCE
215,550 units
DISTRIBUTION Nationwide

PRODUCT Nicotine Transdermal System, 7 mg delivered over 24 hours, 1 patch per pouch.
CODE Lot 37801, Exp 01/12
RECALLING FIRM/MANUFACTURER
AVEVA Drug Delivery Systems, Inc., Miramar, FL,
REASON
Subpotent (Single Ingredient) Drug: AVEVA Drug Delivery Systems Inc. is recalling their 7mg/day Nicotine Transdermal Patch. Some units in Nicotine Transdermal System 7 mg delivered over 24 hours could have low potency or myosmine and beta-nicotyrine impurities above the 0.50% limits in the application specification.
VOLUME OF PRODUCT IN COMMERCE
395,820 units
DISTRIBUTION NY

PRODUCT Nicotine Transdermal System Patch, 14 mg delivered over 24 hours, 1 patch per pouch.
CODE Lot # 37050, Exp 06/11
RECALLING FIRM/MANUFACTURER
AVEVA Drug Delivery Systems, Inc., Miramar, FL,
REASON
Impurities/Degradation Products: recalled due to failures encountered during routine stability testing, resulting in discolored and degraded products.
VOLUME OF PRODUCT IN COMMERCE
428,760 pouches
DISTRIBUTION CA

PRODUCT Thyrolar 3 (liotrix tablets, USP), each tablet contains 37.5 mcg Liothyronine sodium (T3) and 150 mcg Levothyroxine sodium (T4), packaged in 100-ct. bottles, Rx only. NDC 0456-0060-01.
CODE Lot #090808, Exp. August 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Forest Pharmaceuticals Inc., Earth City, MO
Manufacturer: Forest Pharmaceuticals Inc., Cincinnati, OH.
REASON
Exceed Impurity Specification for related compounds.
VOLUME OF PRODUCT IN COMMERCE
2,237/100-count bottles
DISTRIBUTION Nationwide

American Regent Recalls All Lots of Ketorolac
Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials

American Regent is recalling of ALL lots of its Ketorolac Tromethamine Injection, USP 30 mg/mL:

NDC# 0517-0801-25 30 mg/mL 1mL Single Dose Vial

NDC# 0517-0902-25 30mg/mL 2mL Single Dose Vial (60mg/2mL)

This recall is due to the potential that particulate matter in conjunction with crystallization may be present in the product.

The product was distributed to wholesalers and distributors nationwide and to one account in Abu Dhabi.

Hospitals, surgi-centers, clinics and other healthcare facilities should not use any AMERICAN REGENT Ketorolac Tromethamine Injection, USP Injection 30 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.

WEEK ENDING OCTOBER 17

PRODUCT
1) Goldline SENNA-GEN Tablets brand of Standard Senna Concentrate equivalent to 8.6 mg of Sennosides Natural Vegetable Stimulant Laxative 1000 and 100 count Tablets. NDC 0182-1093-10 (1000 count bottle) and NDC 0182-1093-01(100 count bottle) IVAX SENNA-GEN Tablets brand of Standard Senna Concentrate equivalent to 8.6 mg of Sennosides Natural Vegetable Stimulant Laxative 100 (10X10) unit dose tablets. NDC 0812-8215-89 (100 count bottle).

2) Goldline SENNA-S Tablets (brand of Standardized Senna Concentrate Equivalent to 8.6 mg Sennosides and Docusate Sodium 50 mg) Natural Vegetable Laxative and Stool Softner 1000 tablets. NDC 0182-1113-10 (1000 Tablets) and NDC 0182-1113-01 (100 Tablets) IVAX SENNA-S Tablets (brand of Standardized Senna Concentrate Equivalent to 8.6 mg Sennosides and Docusate Sodium 50 mg) Natural Vegetable Laxative and Stool Softner 100 Count Unit Dose Tablets. NDC 0182-8642-89 (1000 Tablets).
CODE
1) 100 Ct Unit Dose, IVAX Label A019UA, A025UA, C040UA, A019UA, A025UA, C040UA 100 Ct bottles, Goldline Label 89A019U, 89A021U, 89A033T, 89A127U, 89A129U, 89B047T, 89B048T, 89B049T, 89D135U, 89E034U, 89F012U, 89F013U, 89F062U, 89G100U, 89G103T, 89G105T, 89J103T, 89K031S, 89K031T, 89K064S, 89K108S, 89K109S, 89M099S 1000 count bottles, Goldline Label 89A020U, 89A128U, 89C081U, 89D031U, 89D104T, 89E003U, 89F010U, 89F037S, 89F059U, 89F061U, 89G017U, 89G102T, 89G103T, 89H099T, 89J102T, and 89J104T;

2) 100 Ct Unit Dose, IVAX Label 89A156U, 89A156UA, 89B046U, 89B046UA, 89G119T, 89G119TA, 89C019T, 89C019TA--- 100 Ct bottles, Goldline Label 89A115U, 89D071U, 89F102S, 89J019S, 89L019S, 89A156UA, 89D072U, 89F103S, 89J063S, 89L081T, 89B045U, 89D074U, 89F104SM 89J064S, 89M026T, 89B062T, 89D081U, 89F007T, 89J065S, 89M062S, 89B064T, 89D104U, 89G019U, 89J105T, 89M071T, 89M065T, 89D105U, 89G115T, 89J125T, 89M072T, 89D034U, 89D108T, 89G119T, 89K113S, 89D035U, 89D109T, 89H053U, 89L018S--- 1000 CT bottles Goldline Label 89A112U, 89A115U, 89B057T, 89B060T, 89B061T, 89D107T, 89D109T, 89D110T, 89F016U, 89F018U, 89F019U, 89F020U, 89F021U, 89F022U, 89G116T, 89G117T, 89G118T, 89G122T, 89H017U, 89H020U, 89H021U, 89H044T, 89H054U, 89J124T, 89K033S, 89K034S, 89L018S, 89L039U, 89L040U, 89M095T, 89M096T
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ivax Pharmaceuticals, Weston, FL, .
Manufacturer: Time-Cap Laboratories, Inc., Farmingdale, NY.
REASON
Undeclared ingredient; may contain undeclared excipients anhydrous lactose and tartaric acid.
VOLUME OF PRODUCT IN COMMERCE
1,521,771
DISTRIBUTION Nationwide

PRODUCT
1) Ranitidine Tablets, USP 150 mg, Rx only. Packaged in 60 count bottles: NDC 0904-5261-52, and 500 count bottles NDC 0904-5261-40.

2) Gemfibrozil Tablets, USP, 600 mg, Rx only. Packaged in 60 count bottles: NDC 0904-5379-52 and 500 count bottles: NDC 0904-5379-40.

3) Gabapentin Capsules, 300 mg, 270 count bottles, Rx only, NDC 0904-5632-53.

4) Metformin Hydrochloride Extended Release Tablets 500 mg, 60 count bottles, Rx only, NDC 68645-120-59.

CODE
1) 60 count bottles: Lot numbers L-1564, Exp. 11/2009; L-1625C, Exp. 02/2010; L-1663A, Exp. 02/2010; and L-1653, Exp. 02/2010; 500 count bottles: Lot numbers L-1564A, Exp. 11/2009; L-1625, Exp. 02/2010; L-1625A, Exp. 02/2010; L-1625B, Exp. 02/2010; L-1663, Exp 02/2010; and L-1653A, Exp. 02/2010;

2) 60 count bottles: Lot numbers L-1853 and L-1916, Exp. date 02/2011; 500 count bottles: Lot number L-1859, Exp. 02/2011;

3) Lot numbers L-1529, Exp. 11/2009, and L-1858, Exp. 02/2011;

4) Lot numbers 090298, Exp. 02/2010; 090666, Exp. 05/2010; 090667, Exp. 05/2010; 090896, Exp. 06/2010; 090898, Exp. 06/2010; 090899, Exp. 06/2010; 090901, Exp. 06/2010; and 090905, Exp. 06/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Legacy Pharmaceutical Packaging LLC, Earth City, MO,
Manufacturer: Apotex, Inc, North York Ontario, Canada.
REASON
Product recalled due to non-compliance with Good Manufacturing Practices.
VOLUME OF PRODUCT IN COMMERCE
94,904 (60 count); 14,169 (270 count); and 4,042 (500 count) bottles
DISTRIBUTION Nationwide

PRODUCT Paroxetine Hydrochloride USP tablets, 40 mg, UD 100 (10x10) tablets per carton, Rx only, NDC 63739-408-10. CODE Lot # 00062092, Exp 12/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mckesson Packaging Services, Concord, NC,
Manufacturer: Apotex Corp. Weston, FL. REASON
CGMP Deviations: Product is being recalled due to significant cGMP violations observed at the manufacturer (Apotex).
VOLUME OF PRODUCT IN COMMERCE
103 cartons (100 tablets per carton)
DISTRIBUTION NC

WEEK ENDING OCTOBER 10

PRODUCT
1) Herbal Disiac Capsules, 250 mg All Natural Herbal Extract, 40 capsule bottle, UPC 8 80907 67733 4.

2) LIBIEXtreme Capsules, 1000 mg Natural Herbal Extract, single capsule packet, UPC 6 20186 60211 1.

3) Y-4ever Capsules, 800 mg All Natural Herbal Extract, single capsule packet, UPC 8 80907 67739 6.

4) POWERMANIA Liquid, 1780 mg Energy & Herbal Blend, 1 fluid ounce packet, UPC 8 80907 67710 5.

5) LIBIMAX X Liquid, 1580 mg Energy & Herbal Blend, 1 fluid ounce packet, UPC 8 80907 67736 5.

6) POWERMANIA Capsules, 1000 mg All Natural Herbal Extract, 1 capsule packet, UPC 8 80907 67711 2.
CODE All lots
RECALLING FIRM/MANUFACTURER Nature & Health Co., Brea, CA, .
REASON Unapproved Drug; Product contains tadalafil, an ingredient used in an FDA approved product for erectile dysfunction
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION Nationwide

PRODUCT Sodium Chromate Cr 51 Injection, Diagnostic, Sterile, Non-Pyrogenic Solution, 250 uCi/vial, 100 uCi/mL, For Intravenous Administration, Rx Only.
CODE Lot # 370-9004, exp. 7/24/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mallinckrodt, Inc., Hazelwood, MO,
Manufacturer: Mallinckrodt, Inc., Maryland Heights, MO.
REASON Subpotent; sodium chromate
VOLUME OF PRODUCT IN COMMERCE
96 vials
DISTRIBUTION Nationwide, Canada, Mexico

PRODUCT
1) STEAM capsules, 5 capsule bottle, UPC 8 52263 30033 1.

2) STEAM capsules, 5 capsule bottle, UPC 8 52263 30033 1.
CODE
1) Lot # 80214, Exp 06/11;
2) Lot # 90260, Exp 06/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nutracoastal Trading, LLC, Freeport, NY,
Manufacturer: Eniran Manufacturing, Farmingdale, NY.
REASON Marketed Without an Approved NDA/ANDA: Private laboratory analysis of STEAM, Lot # 90260 found that the product contains tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making STEAM capsules an unapproved new drug.
VOLUME OF PRODUCT IN COMMERCE
9,435 bottles
DISTRIBUTION Nationwide

PRODUCT Naproxen Tablets, USP, 500 mg tablets, 1000 tablets per bottle, Rx only, NDC 53746-190-10.
CODE Lot # HC06109, Exp 03/13
RECALLING FIRM/MANUFACTURER Amneal Pharmaceuticals, Hauppauge, NY,
REASON Superpotent (Single Ingredient Drug). Tablet Thickness. This product is being recalled because of a report of one oversized (thick) tablet.
VOLUME OF PRODUCT IN COMMERCE
986 bottles
DISTRIBUTION Nationwide

PRODUCT
1) Lac-Hydrin (ammonium lactate) Lotion, 12%, 400 g bottle, NDC 10631-098-14; 225 g bottle. Physician Sample Not For Sale. Not for individual sale. Rx only.

2) Lac-Hydrin (ammonium lactate) Cream, 12%, 385 g bottle, Rx only, NDC 0072-5730-38.
CODE
1) Lot # RB704301, Exp 08/11 (400 g); Lot # RB710701, Exp 06/11 (225 g Physician's Sample);

2) Lot # RB692601, Exp 06/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ranbaxy Pharmaceuticals, Inc., Jacksonville, FL,
Manufacturer: Contract Pharmaceuticals Limited, Buffalo, NY.
REASON Crystallization: Lac-Hydrin Cream and Lotion are being recalled because they have the potential to undergo crystal formation.
VOLUME OF PRODUCT IN COMMERCE
19,871 bottles
DISTRIBUTION Nationwide

PRODUCT Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg, 100 tablets per bottle, Rx only, NDC 53746-0203-01.
CODE The subject bottle was shipped together with the identical product Lot # BC00609, Exp 02/11
RECALLING FIRM/MANUFACTURER Amneal Pharmaceuticals, Brookhaven, NY,
REASON Labeling: Incorrect/Missing Lot No. (s): One bottle of Oxycodone and Acetaminophen 5 mg/325 mg tablets, 100 count bottle was found without a lot number and expiration date.
VOLUME OF PRODUCT IN COMMERCE
6,931 bottles
DISTRIBUTION Nationwide

WEEK ENDING OCTOBER 3

PRODUCT
1) Propofol Injectable Emulsion 1%, 1000 mg/100 mL (10 mg/mL) in 100 mL vials, Rx only, NDC 0703-2859-01.

2) Propofol Injectable Emulsion 1%, 200 mg/20 mL (10 mg/mL) in 20 mL vials, Rx only, NDC 0703-2856-01.

3) Propofol Injectable Emulsion 1%, 500 mg/50 mL (10 mg/mL) in 50 ml vials, Rx only, NDC 0703-2858-01.

4) Propofol Injectable Emulsion 1%, 1000 mg/100 mL (10 mg/mL) in 100 mL vials, Rx only, NDC 0703-2859-01.
CODE
1) Lot # 31305429B, Exp 01/11; Lot # 31305430B, Exp 01/11;

2) Lot # 31305323B, Exp 01/11;

3) Lot # 31305431B, Exp 01/11;

4) Lot # 31305324B, Exp 01/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA,
Manufacturer: Teva Parenteral Medicines, Inc., Irvine, CA.
REASON
Non-Sterility: contamination with endotoxins.
VOLUME OF PRODUCT IN COMMERCE
268,765 vials
DISTRIBUTION Nationwide

PRODUCT Concentrated Acetaminophen Drops, Bulk Pharmacy Container, Institutional Use Only, 80 mg/0.8 mL, 16 oz (473 mL) bottle, NDC 42192-504-16.
CODE All lot codes
RECALLING FIRM/MANUFACTURER
Brookstone Pharmaceuticals, LLC, Alpharetta, GA,
REASON
Possible overdosing may result from product packaging and the absence of an integrated dosage delivery device.
VOLUME OF PRODUCT IN COMMERCE
6,633 bottles
DISTRIBUTION Nationwide

PRODUCT
1) Children's Tylenol Plus, Multi-Symptom Cold, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, Dextromethorphan HBr 5 mg, and Phenylephrine HCl 2.5 mg), 4 fl oz (120 mL) bottles, Grape Flavor, Oral Suspension, Product code 3910400, UPC 300450391049.

2) Children's Tylenol, (acetaminophen 160 mg/5 mL), 4 fl oz (120 mL) bottle, Grape Flavor Oral Suspension. Product code 2960400, UPC 300450296047.

3) Children's Tylenol, (acetaminophen 160 mg/5 mL), 4 fl oz (120 mL) bottle, bubblegum Yum Flavor, Oral Suspension. Product code 4070400, UPC 300450407047.

4) Children's Tylenol, (acetaminophen 160 mg/5 mL), 4 fl oz (120 mL) bottle, very berry Strawberry Flavor, Oral Suspension. Product code 4930400, UPC 300450493040.

5) Concentrated Tylenol, Infants' Drops, (acetaminophen 80 mg/0.8 mL), Grape Flavor. Packaged in the following configurations: 1/4 fl oz (7.5 mL) bottle with dropper, a) Product code 1224000, UPC 300450122407; 1/2 fl oz (15 mL) bottle with dropper, b) Product code 1221500, UPC 300450122155; 1 fl oz (30 mL) bottle with dropper, c) Product code 1220100, UPC 300450122018; 1 fl oz (30 mL) bottle with dropper, d) Product code 1221000, UPC 300450122100; (For Hospital/Government Use Only), 1/2 fl oz (15 mL) bottle, e) Product code 1221800, UPC 350580144183.

6) Concentrated Tylenol, Infants' Drops, (acetaminophen 80 mg/0.8 mL), Cherry Flavor. Packaged in the following configurations: 1/2 fl oz (15 mL) bottle with dropper, a) Product code 1861500, UPC 300450186157; 1 fl oz (30 mL) bottle with dropper, b) Product code 1863000, UPC 300450186300; (For hospital/government use only), 4 fl oz (120 mL) bottle, c) Product code 1230300, UPC 350580123034.

7) Children's Tylenol, (acetaminophen 160 mg/5 mL), 4 fl oz (120 mL) bottle, Dye Free Cherry Flavor, Oral Suspension. Product code 1660400, UPC 300450166043.

8) Children's Tylenol, (acetaminophen 160 mg/5 mL), Cherry Blast Flavor, Oral Suspension. Packaged in the following configurations: 4 fl oz (120 mL) bottle, Product code 1230400, UPC 300450123046; 1 fl oz (30 mL) bottle, Product code 1230100, UPC 300450123015.

9) Children's Tylenol Plus, Cough & Runny Nose, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, and Dextromethorphan HBr 5 mg), 4 fl oz (120 mL) bottle, Cherry Flavor, Oral Suspension. Product code 2490400, UPC 300450249043.

10) Children's Tylenol Plus Flu, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, Dextromethorphan HBr 5 mg, and Phenylephrine HCl 2.5 mg), 4 fl oz (120 mL) bottle, Bubble Gum Flavor, Oral Suspension. Product code 3860400, UPC 300450386045.

11) Children's Tylenol Plus Cold, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, and Phenylephrine HCl 2.5 mg), 4 fl oz (120 mL) bottle, Grape Flavor, Oral Suspension. Product code 3870400, UPC 300450387042.

12) Children's Tylenol Plus Cough & Sore Throat, (each 5 mL contains: Acetaminophen 160 mg and Dextromethorphan HBr 5 mg), 4 fl oz (120 mL) bottle, Cherry Flavor, Oral Suspension. Product code 2470400, UPC 300450247049.

13) Concentrated Tylenol Infants' Drops, (acetaminophen 80 mg/0.8 mL), 1 fl oz (30 mL) bottle with dropper, Dye-Free Cherry Flavor. Product code 1670100, UPC 300450167019.

14) Children's Tylenol Plus Cold & Allergy, (each 5 mL contains: Acetaminophen 160 mg, Diphenhydramine HCl 12.5 mg, and Phenylephrine 2.5 mg), 4 fl oz (120 mL) bottle, Bubble Gum Flavor, Oral Suspension. Product code 3900400, UPC 300450390042.
CODE
1) Lot numbers: SBM041 exp 1/10, SBM067 exp 2/10, SCM037 exp 2/10, SDM027 exp 3/10, and SEM109 exp 5/10;

2) Lot numbers: SBM042 exp 2/10, SCM015 exp 2/10, SCM036 exp 2/10, and SDM034 exp 3/10;

3) Lot numbers: SBM043 exp 2/10, SBM044 exp 2/10, and SCM029 exp 2/10;

4) Lot numbers: SBM045 exp 2/10, SCM011 exp 2/10, SCM030 exp 2/10, and SDM035 exp 3/10;

5) a) Lot numbers: SBM064 exp 2/10, SCM033 exp 3/10, and SDM020 exp 3/10; b) Lot numbers: SCM012 exp 2/10, SCM067 exp 3/10, SDM007 exp 3/10, and SDM068 exp 3/10; c) Lot numbers: SCM082 exp 3/10, SDM039 exp 3/10, and SDM040 exp 3/10; d) Lot number: SDM078 exp 3/10; e) Lot number: SCM034 exp 2/10;

6) a) Lot numbers: SBM065 exp 2/10, SCM005 exp 2/10, SCM006 exp 2/10, and SDM032 exp 3/10; b) Lot numbers: SDM038 exp 3/10 and SDM009 exp 3/10; c) Lot number: SDM028 exp 3/10;

7) Lot numbers: SBM066 exp 2/10 and SCM068 exp 2/10;

8) Lot numbers: SBM068 exp 2/10, SCM035 exp 2/10, SCM070 exp 3/10, SCM080 exp 3/10, and SDM005 exp 3/10; Product code 1230100, Lot number: SDM064 exp 3/10;

9) Lot numbers: SBM069 exp 2/10, SBM070 exp 2/10, SCM081 exp 3/10, and SDM006 exp 3/10;

10) Lot numbers: SCM013 exp 2/10, SCM014 exp 2/10, and SCM069 exp 3/10;

11) Lot numbers: SCM016 exp 2/10 and SFM024 exp 5/10;

12) Lot number: SCM017 exp 2/10;

13) Lot numbers: SCM083 exp 3/10, SCM084 exp 3/10, SDM008 exp 3/10;

14) Lot number: SDM033 exp 3/10
RECALLING FIRM/MANUFACTURER
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA,
REASON
The raw material used to manufacture the finished product may have been contaminated with B cepacia.
VOLUME OF PRODUCT IN COMMERCE
7,983,648 bottles
DISTRIBUTION Nationwide

PRODUCT Advair Diskus 100/50mcg (fluticasone propionate/salmeterol inhalation powder, 100/50mcg), Rx only, NDC 0173-0695-00. Product Order Number: 01730695009.
CODE Lot number: 9ZP7632, Expiration Date: April 2010
RECALLING FIRM/MANUFACTURER
GlaxoSmithKline, Inc., Zebulon, NC,
REASON
Defective delivery system; There is a potential for the foil strip of the inhaler to tear rather than to peel back, which can result in medication not being available to the user as they advance doses through the Diskus unit.
VOLUME OF PRODUCT IN COMMERCE
23,932 units
DISTRIBUTION Nationwide

PRODUCT Balneol for Her, Hydrocortisone 0.25%, Anti-Itch Lotion, a) 20 count/2 gm packets (UPC #3 68220-078-10 1) and b) 3fl.oz (89 mL) bottles (UPC #368220-078-03 3).
CODE
a) Lot number 6911, b) Lot number 6889
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alaven Pharmaceutical LLC, Marietta, GA,
Manufacturer: Span Packaging Services LLC, Greenville, SC.
REASON
Stability testing does not support the potency of the product throughout the product’s shelf life.
VOLUME OF PRODUCT IN COMMERCE
13,128 units
DISTRIBUTION Nationwide

PRODUCT Acetaminophen 500 mg Pain Reliever-Fever Reducer, packaged under the following labels: CareOne Pain Relief Extra Strength Acetaminophen Cooling Sensation Caplets, 500 mg, 100 caplets, OTC; Equaline Extra Strength Pain Relief, acetaminophen, 500 mg, 100 caplets, OTC, NDC 41163-010-78; Good Neighbor Pharmacy Extra Strength Pain Reliever Cool Ice Caplets, acetaminophen, 500 mg, 100 caplets, OTC, NDC 24385-618-78; TopCare Extra Strength Pain Relief, acetaminophen, 500 mg, 100 caplets, OTC, NDC 36800-010-78; TopCare Extra Strength Pain Relief, acetaminophen, 500 mg, 50 caplets, OTC, NDC 36800-010-71.
CODE Lot numbers: 9FE2629 and 9FE2453
RECALLING FIRM/MANUFACTURER
L. Perrigo, Co., Allegan, MI, by letter dated July 29, 2009. Firm initiated recall is ongoing.
REASON
Presence of foreign substance; Incorrect coating on tablets
VOLUME OF PRODUCT IN COMMERCE
56,520 bottles
DISTRIBUTION IL, MN, NY, PA