MARCH 2004

WEEK ENDING MARCH 13

PRODUCT Kaletra (lopinavir/ritonavir) capsules Each soft gelatin capsule contains lopinavir 133.3, rionavir 33.3 mg, RX only.

CODE Lot Numbers/ Expiration Date: 852002E21(12/03); 852072E 25(06/04).
RECALLING FIRM/MANUFACTURER TXRX, Houston, TX.
REASON Counterfeit: An unknown number of bottles these lot numbers are counterfeit, in that they have been repackaged and or/relabeled and may bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE 182 bottles.
DISTRIBUTION Nationwide.

PRODUCT Montana Botanicals Eye Drops (Goldenseal Glycerite and Kollesol in saline), Herbal Extract, 1 oz.
CODE Lot Numbers: 3001, 3002, 3003, 3004, 3005, 3006, 3007, 3008.
RECALLING FIRM/MANUFACTURER Montana Botanicals, Hamilton, MT.
REASON Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE 28/1 oz. vials.
DISTRIBUTION Nationwide.

PRODUCT Darvon Compound USP 32 (Propoxyphene hydrochloride 32 mg, aspirin 389 mg and caffeine 32.4 mg), 100 Pulvules, Rx only.
CODE Lot Numbers: Lot 03082B, 03083B and 03084B.
RECALLING FIRM/MANUFACTURER Aaipharma, Wilmington, NC.
REASON Dissolution Failure: Aspirin and Propoxphene hydrochloride (6 month stability).
VOLUME OF PRODUCT IN COMMERCE 4,328 bottles.
DISTRIBUTION Nationwide.

PRODUCT Mysoline (primidone) Tablets, 50 mg tablets, 500 count bottles. Rx Only.
CODE Lot Number: J0300071.
RECALLING FIRM/MANUFACTURER Xcel Pharmaceuticals, Inc., San Diego, CA.
REASON Tablet hardness failure.
VOLUME OF PRODUCT IN COMMERCE 3,728 bottles.
DISTRIBUTION Nationwide.

PRODUCT PREMARIN (conjugated estrogens tablets, USP), 0.625 mg, 100 count bottles, RX only.
CODE Lot Number/Expiration Date: A30811 (03/05).
RECALLING FIRM/MANUFACTURER Richmond Division of Wyeth, Richmond, VA.
REASON Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE 114,187.
DISTRIBUTION Nationwide.

WEEK ENDING MARCH 20

PRODUCT Clobetasol Propionate Cream, USP, 0.05%, 30 gram tubes, Rx only
CODE Lot Numbers/Expiration Dates: Lot 19877 (8/2004) and Lot 19987 (11/2004).
RECALLING FIRM/MANUFACTURER Teva Pharmaceuticals USA, North Wales, PA.
REASON Impurities/Degradation products: Presence of Benzophenone and Irgacure 184 from the varnish coating on the tubes.
VOLUME OF PRODUCT IN COMMERCE 55,280 units.
DISTRIBUTION Nationwide.

WEEK ENDING MARCH 27

PRODUCT
a) Zyprexa Tablets (Olanzapine), 15 mg, 60 tablet bottles, Rx only,
b) Zyprexa Tablets (Olanzapine), 20 mg, 60 tablet bottles, Rx only.
CODE
a) Lot Number/Expiration Date: Lot 7EF27A (8/1/05), Lot 7EF28A(8/1/05);
b) Lot Number/Expiration Date: Lot 7ED87A (7/1/05); Lot 7EE34A (7/1/05).
RECALLING FIRM/MANUFACTURER FPP Inc, Cincinnati, OH.
REASON Counterfeit : An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE 67 bottles.
DISTRIBUTION Nationwide.

PRODUCT Dakin's Solution 0.25% By Century Half Strength, (0.25% sodium hypochlorite), 473 mL 16 Fl. OZ.
CODE Lot Number: 871/Expiration Date: 10/27/2004.
RECALLING FIRM/MANUFACTURER Century Pharmaceuticals, Inc, Indianapolis, IN.
REASON Subpotent: Stability assay failed to meet specification limits.
VOLUME OF PRODUCT IN COMMERCE 1,200.
DISTRIBUTION Nationwide.

PRODUCT Butalbital, Aspirin & Caffeine Tablets,USP, 50mg-Butalbital/325mg-Aspirin/40mg-Caffeine, CIII,
100 count bottles, Rx only.

CODE Lot Number/Expiration Date: 539C21, 04/2004; 541C21, 04/2004; 743D21, 05/2004; 744D21, 05/2004;
745D21, 05/2004; 746D21, 05/2004; 281F21, 07/2004; 284F21, 07/2004; 285F21, 08/2004.
RECALLING FIRM/MANUFACTURER Alpharma Purepac, Elizabeth, NJ.
REASON Stability Failure: Product lacks stability for Butalbital drug ingredient.
VOLUME OF PRODUCT IN COMMERCE 96,113.
DISTRIBUTION Nationwide.

PRODUCT Aspirin and Codeine Phosphate Tablets, USP, 325 mg/60 mg, 100 count bottles, Rx only.
CODE Lot Number 101304A/Expiration Date: 3/2004.
RECALLING FIRM/MANUFACTURER IVAX Pharmaceuticals, Miami, FL.
REASON Stability Failure: Product is exceeding the stability specification for free Salicylic Acid.
VOLUME OF PRODUCT IN COMMERCE 4,392 bottles.
DISTRIBUTION Nationwide.

PRODUCT MGP Promethazine with Codeine Cough Syrup; (Promethazine Hydrochloride 6.25 mg/5mL and Codeine Phosphate 10 mg/5mL; 4 oz. Bottles. Rx Only.
CODE Lot numbers: 25016A, 25091A, 25103A, 25408A, 25409A,25457A, 25525A.
RECALLING FIRM/MANUFACTURER Morton Grove Pharmaceuticals, Inc., Morton Grove, IL.
REASON Discoloration, (18 month stability).
VOLUME OF PRODUCT IN COMMERCE 149,505 bottles.
DISTRIBUTION Nationwide.

PRODUCT Questran Powder (Cholestyramine for Oral Suspension, USP) 4 grams cholestyramine resin, USP per scoopful, 378 G (168 G anhydrous cholestyramine) Cans, Rx Only.
CODE Lot 3A63688.
RECALLING FIRM/MANUFACTURER Bristol-Myers Squibb Co., New Brunswick, NJ.
REASON Superpotent (6 month stability).
VOLUME OF PRODUCT IN COMMERCE 18,571 cans.
DISTRIBUTION NY.