AUGUST 2003

WEEK ENDING AUGUST 9

PRODUCT LIPITOR Tablets, (ATORVASTATIN CALCIUM), 20 MG, 90 and 1000 TABLETS bottles, Rx only.
CODE Lot 0511022.
RECALLING FIRM/MANUFACTURER Recalling Firm: Local Repack, Inc., Richton Park, IL.
Manufacturer: Unknown.
REASON Counterfeit product.
VOLUME OF PRODUCT IN COMMERCE 7,189 - 90 tab bottles, 15 - 1000 tab bottles
DISTRIBUTION Nationwide.

PRODUCT Children's Kaopectate (Bismuth Subsalicylate), 87mg/5mL, 6 fl oz (177 mL), Anti-Diarrheal, New & Improved, Cherry.
CODE Lots 86JHT and 01JKC.
RECALLING FIRM/MANUFACTURER Pfizer, Inc., Morris Plains, NJ.
REASON Mislabeled; the dosing cup does not contain the appropriate dosing units of measure for teaspoon or mL as listed on the product's label dosing chart.
VOLUME OF PRODUCT IN COMMERCE 385,241 bottles
DISTRIBUTION Nationwide, Barbados, and Guyana.

PRODUCT CLOBETASOL PROPIONATE TOPICAL SOLUTION, USP, 0.05%, (0.5 mg/g), Rx Only, 25 mL (0.85 FL OZ) and 50 mL (1.7 FL OZ) plastic bottles.
CODE
Lot/Exp: RF1331 05/02 (25 mL and 50 mL), RH1441 06/02 (50 mL), RJ1586 08/02 (50 mL), RJ1588 08/02 (25 mL and 50 mL), RN1918 09/02 (50 mL), RP1996 10/02 (25 mL and 50 mL), RS1125 12/02 (25 mL and 50 mL), RA2011 02/03 (25 mL and 50 mL).
RECALLING FIRM/MANUFACTURER Alpharma USPD, Baltimore, MD.
REASON Largest Related Substance Failure; Benzophenone (from varnish coating on container label).
VOLUME OF PRODUCT IN COMMERCE 295,228 bottles.
DISTRIBUTION Nationwide.

PRODUCT Ray Block Sunscreen Lotion, (Octyl Dimethyl PABA 5% and Benzophenone 3.3%) SPF 15, 1 FL OZ (29.6mL) and 4 FL OUNCES (118.3 mL).
CODE Lot D32, expiration date 04/05.
RECALLING FIRM/MANUFACTURER Recalling Firm: Crown Laboratories, Inc., Johnson City, TN.
Manufacturer: DEL-RAY LABS, INC., Birmingham, AL. Firm initiated recall is ongoing.
REASON Superpotent; octyl dimethyl PABA and oxybenzone.
VOLUME OF PRODUCT IN COMMERCE 319-4 oz and 324-1 oz bottles.
DISTRIBUTION Nationwide.

PRODUCT LITHOBID Tablets (Lithium Carbonate, USP) Slow Release Tablets, 300 mg, 100 tablet bottles, Rx only.
CODE Lot 92263.
RECALLING FIRM/MANUFACTURER Solvay Pharmaceuticals, Inc., Marietta, GA.
REASON Dissolution failure; 12 month stability.
VOLUME OF PRODUCT IN COMMERCE 14,029 bottles of 100 tablets.
DISTRIBUTION Nationwide.

PRODUCT Premarin Tablets, (Conjugated Estrogens Tablets, USP), 0.625 mg, 100 tablet bottles, Rx Only.
CODE 03831 Exp 4/04.
RECALLING FIRM/MANUFACTURER Recalling Firm: McKesson, Memphis, TN.
Manufacturer: Ayerst Laboratories, Inc., A Wyeth-Ayerst Company, Philadelphia, PA.
REASON Dissolution Failure by the manufacturer (Wyeth).
VOLUME OF PRODUCT IN COMMERCE 39,793 bottles.
DISTRIBUTION Nationwide.

WEEK ENDING AUGUST 23

PRODUCT
a) HYDROCHLORIC ACID Injection, 2 mg/mL (1:500), Sterile, 100 Ml Multiple Dose Vial, FOR INTRAVENOUS USE, Caution: For Office,
Clinic, or Hospital Use, Innovative Professional Services, Portage, MI.
b) PYRIDOXINE Injection, (Pyridoxine HCL) 100 mg/mL, Sterile, 30 ml Multiple Dose Vial, FOR I.M. or I.V. Use, Caution: For Office,
Clinic, or Hospital Use, Innovative Professional Services, Portage, MI.
c) DEXPANTHENOL Injection, (DL-Panthenol) 250 mg/mL, Sterile, 30 mL Multiple Dose Vial, FOR I.M. or I.V. Use, Caution: For
Office, Clinic, or Hospital Use, Innovative Professional Services, Portage, MI.
d) FOLIC ACID Injection, (Folic acid 10mg, sodium chloride 5.5mg, methylparaben 1.8mg, propylparaben 0.2mg), 10mg/mL, 10mL multiple
dose vial, Innovative Professional Services, Portage, MI.
e) THIAMINE Injection, (Thiamine HCL 100 mg, Chlorobutenol 3mg), 100 mg/mL, Sterile, 30 mL, Multiple Dose Vial FOR I.M. or I.V.
Use, Caution: For Office, Clinic, or Hospital Use. Innovative Professional Services, Portage, MI.
f) B-COMPLEX 100 Injection, (Thiamine HCl 100mg, Riboflavin 5mg, Pyridoxine HCl 100mg, Dexpanthenol 100mg), Sterile, 30 mL Multiple
Dose Vial, FOR I.M. or SLOW I.V. USE, Caution: For Office, Clinic, or Hospital Use, Innovative Professional Services, Portage, MI.
g) EDETATE DISODIUM Injection (E.D.T.A.) 150 mg/mL, Sterile, 100 mL Multiple Dose Vial, FOR INTRAVENOUS USE ONLY, For Office, Clinic, or Hospital Use, Innovative Professional Services, Portage, MI.
h) HYDROXO B-12 Injection, (Hydroxocobalamin 1000mcg, Sod. Chloride 8mg, Sod. Acetate, 0.33mg), 1000mcg/mL, Sterile, 30 mL Multiple
Dose Vial, FOR I.M. or S.C. USE, For Office, Clinic, or Hospital Use, Innovative Professional Services, Portage, MI.
CODE All lots.
RECALLING FIRM/MANUFACTURER Torrance, Co., Portage, MI.
REASON Lack of assurance of sterility by manufacturer (IPS).
VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Nationwide.

PRODUCT Nortrel 7/7/7 Oral Contraceptive Tablets (norethindrone and ethinyl estradiol tablets, USP - triphasic regimen), 28 DAY REGIMEN, 6 blister card, 28 Tablets Each, Rx only, Each light yellow tablet contains 0.5mg norethindrone and 0.035mg ethinyl estradiol. Each blue tablet contains 0.75mg norethindrone and 0.035mg ethinyl estradiol. Each peach tablet contains 1mg norethindrone and 0.035mg ethinyl estradiol. Each white tablet contains inert ingredients.
CODE Lots 290122001, 290122002, 290122003.
RECALLING FIRM/MANUFACTURER Barr Laboratories, Inc., Pomona, NY.
REASON Mispacked; color-coded tablets are packaged in improper sequence as white, peach, blue, yellow rather than in correct sequence as yellow, blue, peach, white.
VOLUME OF PRODUCT IN COMMERCE 469,938 blister cards.
DISTRIBUTION Nationwide, and Puerto Rico.

PRODUCT Combipatch Transdermal System, (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day, 3 Patient Calendar Packs of 8 Systems, Rx only. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey
CODE Lot Number: 61921011, Expiry 06-2004.
RECALLING FIRM/MANUFACTURER Recalling Firm: Novartis Pharmaceuticals, Corp, Suffern, NY.
Manufactured by: Noven Pharmaceuticals, Inc., Miami, Florida.
REASON Subpotency (estradiol/NETA) and Degradation failure (excess primary estradiol degradant).
VOLUME OF PRODUCT IN COMMERCE 256,608 patches.
DISTRIBUTION Nationwide.

PRODUCT Celestone Soluspan Injectable Suspension, USP, 6 mg/mL, (betamethasone sodium phosphate and betamethasone acetate), 5mL Multiple-Dose Vial, Rx Only.
CODE Batch No. 2-AHU-12, Expiry June 2004.
RECALLING FIRM/MANUFACTURER Schering Corp, Kenilworth, NJ.
REASON Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE 35,527 vials.
DISTRIBUTION Nationwide.

PRODUCT Levoxyl Tablets, (Levothyroxine Sodium Tablets, USP), 75mcg, 100 and 1000 tablet bottles and physician sample packets of 7, Rx only.
CODE Lot Nos. 100's - 7594, 7595, 7597, 7599, 7601, Expiration 11/03; 1000's - 7593, 7598, 7602, 7604, Expiration 11/03; Physician Samples - 7596, Expiration 11/03.
RECALLING FIRM/MANUFACTURER King Pharmaceuticals, Inc., Bristol, TN.
REASON Subpotent (stability).
VOLUME OF PRODUCT IN COMMERCE 175,658 bottles.
DISTRIBUTION Nationwide.

PRODUCT
a) Premarin Tablets (conjugated estrogens tablets, USP) 0.625mg, 100 and 1000 tablet bottles, Rx only.
b) Premarin Tablets (Conjugated Estrogens Tablets, USP), 0.625mg., 1000 count bottles, Rx only, Distributor: AmerisourceBergen, Control# 1J00088, Prod. Lot# 103426 (carton label)-----Premarin 0.625mg,(Conjugated Estrogens Tablets, USP) 1000 tablet bottles, Rx Only. Repackaged by: RightPak, Inc., Madison, WI (bottle label).
CODE 100 count bottles: Lots 011765A , 011895A, 011895B; 1000 count bottles: Lots 011765B, 011897, 1J00088.
RECALLING FIRM/MANUFACTURER Recalling Firm: American Health Packaging, Columbus, OH.
Manufacturer: Ayerst Laboratories, Inc., A Wyeth-Ayerst Company, Philadelphia, PA.
REASON Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE 22,060 bottles.
DISTRIBUTION Nationwide.

PRODUCT 0.25% BUPIVACAINE HCL and EPINEPHRINE 1:200,000 Injection, 30 mL Single-dose Vials, Sterile, nonpyrogenic, Rx only.
CODE Lot number 03-504-DK.
RECALLING FIRM/MANUFACTURER Abbott Labs., North Chicago, IL.
REASON Mislabeled; expiration date is incorrectly printed on vial label as "1 October 200" rather than correctly as "1 October 2004".
VOLUME OF PRODUCT IN COMMERCE 35,950 vials.
DISTRIBUTION Nationwide.

PRODUCT Senokot-S Tablets (sennosides 8.6mg and docusate sodium The Purdue Fred50mg) Natural Vegetable Laxative Plus Softener, standardized senna concentrate and docusate sodium, 10 count carton.
CODE Lot PP51.
RECALLING FIRM/MANUFACTURER The Purdue Frederick Company, Stamford, CT.
REASON Subpotent (sennosides).
VOLUME OF PRODUCT IN COMMERCE 141,408/10 count cartons.
DISTRIBUTION Nationwide.

PRODUCT Premarin Tablets (conjugated estrogens tablets, USP), 0.625 mg, 100 tablet bottles, Rx only, Ayerst Laboratories Inc., A Wyeth-Ayerst Company, Philadelphia, PA 19101, Repackaged by: National PharmPak Services, Zanesville, OH.
CODE Lot # 9010664Y, Exp. 12/03.
RECALLING FIRM/MANUFACTURER Cardinal Health, Zanesville, OH.
REASON Dissolution Failure: by manufacturer (Wyeth).
VOLUME OF PRODUCT IN COMMERCE 13,598 bottles.
DISTRIBUTION Nationwide.

WEEK ENDING AUGUST 30

PRODUCT
a) Accutane Capsules, (Isotrentinoin) 10 mg, prescription pak of 10 capsules, Rx only, Roche Laboratories, Inc., Nutley, NJ.
b) Accutane Capsules, (Isotretinoin) 20 mg, prescription pak of 10 capsules, Rx only, Roche Laboratories, Inc., Nutley, NJ.
c) Accutane Capsules, (Isotretinoin) 40 mg, prescription pak of 10 capsules, Rx only, Roche Laboratories, Inc., Nutley, NJ.
CODE Any code missing labeling.
RECALLING FIRM/MANUFACTURER Hoffmann La Roche, Inc., Nutley, NJ.
REASON Mislabeled; the yellow qualification sticker does not contain the words "No refills allowed".
VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Nationwide.