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FDA RECALLS & COURT ACTIONS: March 11, 1992

Executive Summary

CLASS II -- ALL UNIT-DOSE REPACKED OTC AND Rx DRUGS Packaged by the recalling firm. This includes a total of 680 different tablet and capsule products. Recall number: D-240-2. All lots of the drugs repacked between July 1, 1991 and Dec. 11, 1991. This represents all drugs remaining on the market and still within the assigned expiry period. Manufacturer: Various. Recalled by: Murfreesboro Pharmaceutical Nursing Supply, Inc., Murfreesboro, Tennessee (repacker/responsible firm), by telephone Dec. 12, 1991, followed by letter Dec. 15, 1991. Firm-initiated recall complete. Distribution: Tennessee. 1,031,780 tablets and capsules were distributed; firm estimates none remains on the market. Reason: Mislabeling, product mix-ups, current good manufacturing practice deficiencies. CLASS II -- (a) ANACIN TABLETS; (b) MAXIMUM STRENGTH ANACIN TABLETS (a) Containing Aspirin 400 mg/Caffeine 32 mg, an OTC analgesic, in 12 count tins and 30, 50, 100, 200 and 300 count bottles; (b) containing Aspirin 500 mg/Caffeine 32 mg, coated tablets, an OTC analgesic, in 20, 40, and 75 count bottles. Recall number: D- 241/242-2. Lot numbers: (a) K109 - K122, K126, K127, L103-L106, L109-L111 (tins of 12 tablets); L102-L105 (Bottles of 30); L106-L109 (bottles of 50); K106, K107, K109, K111, K112, K113 (bottles of 100); K118, K119, K120 (bottles of 200); K121 (bottles of 300); (b) K125, K126 (bottles of 20); K116, K117 (bottles of 40); K114 (bottles of 75). Both products have a 4 year expiration date. Manufacturer: Whitehall Laboratories, Inc., Hammanton, New Jersey. Recalled by: Whitehall Laboratories, Inc., Division of American Home Products Corporation, New York, New York, by letter Dec. 30, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. (a) 24,703,536 tablets; (b) 3,265,920 tablets were distributed; FDA and recalling firm estimates 50% to 75% of product remain on the market. Reason: Possible presence of metal particles. CLASS II -- CHILDREN's ACETAMINOPHEN ELIXIR (OTC) In 4 ounce bottles, a liquid non-prescription, non-aspirin drug. Recall number: D-243-2. Lot numbers and EXP dates: YL0081 2/92, YL0111 2/92, YL0131 2/92, YL0141 2/92, YL0151 2/92, YL0171 2/92, DL0841 5/93, DL3101 10/93, DL3751 11/93. Manufacturer: Mova Pharmaceutical Corporation, Villa Blanca, Caguas, Puerto Rico. Recalled by: Manufacturer, by letter Jan. 31, 1992. Firm-initiated recall ongoing. Distribution: Puerto Rico. 157,118 units were distributed; firm estimates 40,000 units remain on the market. Reason: Markings on dosage cup not totally compatible with label dosage instructions. CLASS II -- VARIOUS LANNETT-MANUFACTURED DRUG PRODUCTS (a) Phentermine Tablets, 30 mg; Prednisone Tablets, 5 mg and 20 mg; Amphetamine Sulfate Tablets, 5 mg and 10 mg; Laniazid Tablets, 50 mg, 100 mg, and 300 mg; Primidone Tablets, 250 mg; Promethazine HCl Tablets, 12.5 mg, 25 mg, and 50 mg; Diphenylan Sodium Capsules, 30 mg, and 100 mg. Recall number: D-245/258-2. (b) All remaining products that have a valid expiration date. Recall number: D-259-2. All lots. Manufacturer: Lannett Company, Inc., Philadelphia, Pennsylvania. Recalled by: Manufacturer, by letter on or about Nov. 20, 1991. Firm-initiated recall ongoing. Distribution: Nationwide. Undetermined quantity. Reason: (a) Products manufactured without approved supplements to Abbreviated New Drug Applications; (b) Current good manufacturing practice deficiencies. CLASS III -- BUFFERED ASPIRIN, USP 200 mg, in 100 tablet bottles. Recall number: D-244-2. Code 3/93 D1179C, 7/93 J1143J. Manufacturer: Hall Laboratories, Inc., Portland, Oregon. Recalled by: Manufacturer, by letter Nov. 1, 1991. Firm-initiated recall ongoing. Distribution: California. 2,076 bottles were distributed. Reason: Label declares aspirin as 200 mg. Label correctly declares aspirin as 325 mg. CLASS III -- DYRENIUM (TRIAMTERENE) CAPSULES For oral use, a potassium-conserving diuretic, 50 mg, in bottles of 100 and single unit dose 100s in PVC/foil blister packages, and 100 mg capsules in bottles of 100, 1000 and single unit dose 100s PVC/foil blister packages. Recall number: D-261/262-2. All lots ending in 7H06, 8H06 (50 mg); All lots ending in 7H07, 8H07 (100 mg). Manufacturer: SmithKline Beecham Pharmaceuticals Company, Cidra, Puerto Rico. Recalled by: Manufacturer, by letter Feb. 25, 1992. Firm-initiated recall ongoing. Distribution: Nationwide. 76,438 units were distributed; firm estimates none remains on the market. Reason: Product does not meet dissolution specifications. CLASS III -- VARIOUS PRESCRIPTION DRUGS Recall number: D-260-2. All lots. Manufacturer: Various. Recalled by: Total Care Pharmacy, Copley, Ohio (repacker/responsible firm), by letter Jan. 16, 1992. Firm-initiated recall complete. Distribution: Ohio. Undetermined quantity. Reason: Current good manufacturing practice deficiencies. SEIZURE ACTIONS FILED -- L-ARGININE, CYSTENE, L-ORNITHINE, AND L-PHENYLALANINE TABLETS Charge: Products are unapproved new drugs. Misbranded -- Products' labeling lacks adequate directions for safe and effective for use in the prevention or treatment of disease conditions for which representations and suggestions are contrary to fact. Firm: Vitamin Specialties Company, Wyncote, Pennsylvania. Filed: Aug. 29, 1991 -- U.S. District Court for the Eastern District of Pennsylvania; Civil number 91-4588, FDC number 66236. Seized: July 19, 1991 -- goods valued at approximately $13,000. SEIZURE ACTIONS FILED -- VARIOUS REPACKAGED HUMAN DRUGS Charge: Adulterated -- Methods used in, and the controls used for their processing and packing do not conform to and are not operated and administered in conformity with current good manufacturing practice regulations. Firm: Pharmacy Dispensing Quantities, Inc., Ft. Scott, Kansas. Filed: Feb. 26, 1992 -- U.S. District Court for the District of Kansas; Civil number 92-2082-0; FDC number 66348. Seized: Feb. 26, 1992 -- 220,203 bottles valued at approximately $8.9 million. DISPOSITION OF INJUNCTION -- GENERIC DRUG PRODUCTS Defendant: Able Laboratories, Inc., South Plainfield, New Jersey. Charge: Adulterated -- The methods used for, the manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practices. Filed: Nov. 6, 1991 -- U.S. District Court for District of New Jersey; Civil number 91-4916 (AJL), INJ 1268. Disposition: March 2, 1992 -- An agreed Order signed by both parties and the District Court Judge was filed.
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