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FDA RECALLS & COURT ACTIONS: June 16, 1993

Executive Summary

CLASS II - PERITRATE SA (PENTAERYTHRITOL TETRANITRATE) SUSTAINED ACTION TABLETS In bottles of 100, indicated for the relief of angina pectoris. Recall number: D-278-3. All lots within expiration date. Manufacturer: Warner Lambert, Inc., Vega Baja, Puerto Rico. Recalled by: Parke-Davis, Division of Warner Lambert Company, Morris Plain, New Jersey, by letter on or about June 1, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 253,550 units were distributed. Reason: Dissolution specification not assured through expiration date. CLASS III - EQUAGESIC TABLETS (MEPROBAMATE WITH ASPIRIN) In bottles of 100, used for the treatment of pain in patients with musculoskeletal disease. Recall number: D-275-3. Lot number 9920691. Manufacturer: Wyeth-Ayerst Laboratories, St. Davids, Pennsylvania. Recalled by: Manufacturer, by letter May 24, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 6,978 bottles were distributed. Reason: Some tablets contain only the meprobamate component. CLASS III - LIDOCAINE HCL ORAL TOPICAL SOLUTION, USP, 2% (VISCOUS) An Rx topical anesthesia for use on irritated mucous membranes of the mouth and pharynx, in 20 ml (PBI label only) and 100 ml bottles under the following labels: PBI, GG (Geneva), Goldline, Rugby, Qualitest, Major. Recall number: D-277-3. Lot number 19165 EXP 10/31/94 (100 ml) and 10/31/93 (20 ml). Manufacturer: Pharmaceutical Basics, Inc., Morton Grove, Illinois. Recalled by: Pennex Pharmaceuticals, Inc., Morton Grove, Illinois, by letter June 4, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 3,392 20-ml bottles and 86,979 100-ml bottles were distributed. Reason: Superpotent. CLASS III - MALLINCKRODT MEDICAL TECHNESCAN DTPA KIT For the preparation of Technetium TC 99m Penetate, packaged in 5 vial kits and 30 vial kits. Recall number: D-274-3. Lot number 2272 EXP 8/95. Manufacturer: CIS-US, Inc., Bedford, Massachusetts. Recalled by: Manufacturer, by letters of May 11 and 14, 1993. Firm- initiated recall ongoing. Distribution: Nationwide, Panama, Mexico, Jamaica, Phillipines; 402 5-packs and 254 30-packs were distributed. Reason: Expiration date is August 1994 instead of declared August 1995. SEIZURE - PROSTAZINC TABLETS (93-556-601) Charges: New drug -- The article is an unapproved new drug. Misbranded -- The article's labeling is false and misleading, fails to contain all required words, statements, and other information, and fails to bear adequate directions for use. Firm: Food Health Services & Ideas, Miami, Florida. Filed: March 23, 1993; U.S. District Court for the Southern District of Florida; Civil number 93-0521-CIV-ATKINS; FDA number 66656. Seized: March 24, 1993 - goods valued at approximately $50,000.
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