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FDA RECALLS & COURT ACTIONS: December 1, 1993

Executive Summary

CLASS II -- FOREST ARMOUR THYROID (Thyroid tablets, USP), 2 g, in 100-tablet bottles, Rx used as replacement or supplemental therapy in patients with hypothyroidism. Recall number: D-034-4. FP0050 EXP 2/95. Manufacturer: Rhone-Poulenc Rorer, Manati, Puerto Rico. Recalled by: Forest Pharmaceuticals, Inc., St. Louis, Missouri, by letter October 20, 1993. Firm- initiated recall complete. Distribution: Nationwide; 27,678 bottles were distributed. Reason: Some bottles do not bear a lot number and/or expiration date. CLASS II -- G.B.S. TABLETS In 100 and 1,000 tablet bottles, Rx, for use as an adjunct, in the management of certain conditions involving the biliary tract. Recall number: D-035-4. Lot number 11905 EXP 1/94. Manufacturer: Forest Pharmaceuticals, Inc., Cincinnati, Ohio. Recalled by: Forest Pharmaceuticals, Inc., St. Louis, Missouri, by telephone August 17, 1993. Firm-initiated recall complete. Distribution: Nationwide; 394 100-tablet bottles and 89 1,000-tablet bottles were distributed. Reason: Product failed stability specifications. CLASS II -- INOCOR LACTATE INJECTION (Brand of amrinone lactate), sterile intravenous solution 100 mg/20 ml, indicated for the short-term management of congestive heart failure. Recall number: D-032-4. Lot numbers: B989KF, B990KF, B986KE, B987KE, B654KF, B988KF. Manufacturer: Sterling Pharmaceuticals, Inc., a division of Sanofi Winthrop, Barceloneta, Puerto Rico. Recalled by: Sanofi Winthrop Pharmaceuticals, New York, New York, by letter November 11, 1993. Firm-initiated recall complete. Distribution: Nationwide, Puerto Rico, India, Argentina; 86,734 units were distributed. Reason: Package insert contains a typographical error in the dosage and administration section. CLASS II -- QUICKLY WEIGHT-LOSS CAPSULES Promoted to enhance weight loss, in single-unit dose packets. Recall number: D-030-4. All lots. Manufacturer: Neways, Inc., Salem, Utah. Recalled by: Manufacturer, by letter November 8, 1993. Firm- initiated recall ongoing. See also FDA press release P93-41, November 12, 1993. Distribution: Nationwide, Canada, Puerto Rico; 4,903 units (20 dose packages per container). Reason: Product contains undeclared furosemide (a prescription drug) and was marketed without approval. CRIMINAL INFORMATION -- BARRY DAVID GARFINKEL Child psychiatrist and clinical investigator, University of Minnesota, who headed a study of the drug Anafranil, manufactured by Ciba-Geigy. Charges: Dr. Garfinkel was convicted of two counts of mail fraud (18 U.S.C. 1341) and 3 counts of making false statements (18 U.S.C. 1001). He was sentenced to six months imprisonment, followed by six months home detention, and three years probation. Dr. Garfinkel was fined $25,000 ($5,000 for each conviction) and $250 (special assessment due immediately). He was ordered to make restitution to Ciba-Geigy in the amount of $170,394. To pay for his incarceration, Dr. Garfinkel was ordered to pay $1,000 for each month of incarceration, and $180 a month for the three years probation. Dr. Garfinkel was further ordered to perform 400 hours of community service. Filed: November 19, 1993 - Sentencing; U.S. District Court for the District of Minnesota, Fourth Division; Case No. 4-93-34; FDC number 66144.

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