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FDA RECALLS & COURT ACTIONS: Jan. 15, 1992

Executive Summary

CLASS II -- EPINEPHRINE INJECTION, Rx, USP 1:1000, in 1 ml tubex cartridge units, sterile, 10 units per intermediate carton, 60 intermediate cartons per shipper carton, used in the treatment of anaphylactic reactions, cardiac arrest, allergic reactions, and asthma attacks. Recall number: D-142-2. Lot numbers: 4897038, 4897039, 4897040, 4900013, 4900050, 4900051, 4900061, 4900119, 4900120, 4900121, 4900122, 4900123, 4900124, 4900125, 4900126, 4900127, 4900128, 4900129, 4900130, 4900162, 4900197, 4900198, 4900241, 4900439, 4900536. Packages may also carry the suffix "A". Manufacturer: Wyeth-Ayerst Labs, Division of American Home Products, Marietta, Pennsylvania. Recalled by: Wyeth-Ayerst Labs, Division of American Home Products, St. Davids, Pennsylvania, by media release Dec. 13, 1991, followed by letter Dec. 16, 1991. Firm-initiated recall ongoing. Distribution: Nationwide, Puerto Rico, Norway, Sweden. 156,097 packages of 10 syringes each were distributed. Reason: Subpotency. CLASS II -- RITE AID BRAND JUNIOR STRENGTH ACETAMINOPHEN Grape flavored chewable tablets, 24 tablets, 160 mg each, in blister packaging on sleeves each containing 6 individual tablets, an OTC drug product that provides fast, effective, temporary relief of fever and discomfort due to colds and flu. Recall number: D-143-2. Lot number P7348 EXP 10/93. Manufacturer: LNK International, Inc., Hauppauge, New York. Recalled by: Manufacturer, by telephone Dec. 23, 1991, followed by letter on or about Dec. 30, 1991. Firm-initiated recall ongoing. Distribution: West Virginia, Florida, New York, South Carolina, Pennsylvania. Approximately 480,000 tablets were distributed. Reason: The unit carton label has a misprint regarding the dosage for children 12- 14 years. CORRECTION: Robitussin Guaifenesin Syrup, USP, Expectorant, 8 ounces, and Robitussin DM, Cough Suppressant -- Expectorant, 8 ounces, recalled by the Consumer Products Division of A.H. Robins Company, Recall number: D-089/090-2 which appeared in the Nov. 27, 1991 Enforcement Report ["The Pink Sheet" Dec. 2, T&G-12] incorrectly included lot number 91-185-2 as a lot being recalled. This lot is not being recalled. INJUNCTION ACTIONS FILED -- GENERIC DRUG PRODUCTS Against: Able Laboratories, Inc., South Plainfield, New Jersey. Charge: Adulterated -- The methods used in, and the facilities or controls used for, the products' manufacture, processing, packing, and holding do not conform to and are not operated and administered in conformity with current good manufacturing practice regulations. Filed: Nov. 6, 1991 -- U.S. District Court for the District of New Jersey; Civil number 91- 4916(AJL), INJ number 1268. INJUNCTION ACTIONS FILED -- GENERIC DRUG PRODUCTS Against: Zenith Laboratories, Inc., Northvale, New Jersey. Charge: Adulterated -- The methods used in, and the facilities or controls used for, the products' manufacture, processing, packing, and holding do not conform to and are not operated and administered in conformity with current good manufacturing practice regulations. Filed: Nov. 8, 1991 -- U.S. District Court for the District of New Jersey; Civil number 91-4935(DRD), INJ number - 1256. SEIZURE ACTIONS FILED -- AMINO ACID TABLETS Charge: Products are unapproved new drugs; misbranded -- products' labeling lacks adequate directions for their safe and effective use. Firm: Edom Laboratories, doing business as Consumer Vitamin Values, Deer Park, New York. Filed: Aug. 29, 1991 -- U.S. District Court for the Eastern District of New York; Civil number 91-CV-3337, FDC number 66257. Seized: Sept. 5, 1991. SEIZURE ACTIONS FILED -- ARTICLES OF DRUG (CATECHIN, METOX, MYCODICIN, HEPASIL, CAMPYCIDIN, AND OSTEOCAP) Charge: Products are unapproved new drugs. Firm: Thorne Research, Inc., Sandpoint, Idaho. Filed: Nov. 19, 1991 -- U.S. District Court for the District of Idaho; Civil number 91-0484 N HL4, FDC number 66276. Seized: Dec. 18, 1991, various unapproved new drugs valued at $24,231.

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