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FDA RECALLS & COURT ACTIONS: April 15, 1992

Executive Summary

CLASS II -- DISOPYRAMIDE PHOSPHATE 100 MG & 150 MG ORAL CAPSULES An Rx antiarrhythmic. Recall number: D-291/292-2. Lot numbers: L00190 and L00290. Manufacturer: Interpharm, Inc., Plainview, New York. Recalled by: Manufacturer, by telephone followed by letter March 13, 1992. Firm-initiated recall ongoing. Distribution: Florida, Georgia, Michigan, New York, Tennessee. 200 units of lot L00190 and 4000 units of lot L00290. Reason: Lack of assurance of bioequivalency and abbreviated new drug application discrepancies. CLASS III -- LEVOTHROID 200 MCG, LEVOTHYROXINE SODIUM USP In 100 tablet bottles, a Rx oral drug for use as replacement or substitution therapy for diminished or absent thyroid function. Recall number: D-293-2. Code 417-1 EXP 2/1/94. Manufacturer: Pharmacy Dispensing Quantities, Inc., Fort Scott, Kansas (repacker/responsible firm). Recalled by: Repacker, by letter March 27, 1992. Firm-initiated recall ongoing. Distribution: Texas, North Dakota, Illinois, Missouri, Kansas, Puerto Rico. 123 bottles were distributed. Reason: Repacking firm used incorrect expiration date of 2/1/94 instead of 2/1/93. CLASS III -- PHENOLATED CALAMINE LOTION, USP In 4 ounce bottles. Recall number: D-290-2. Lot number 5486. Manufacturer: Hydrox Laboratories, Elgin, Illinois. Recalled by: Manufacturer, by letter March 20, 1992. Firm-initiated recall ongoing. Distribution: Pennsylvania. 25,400 bottles were distributed. Reason: Subpotency of phenol ingredient. DISPOSITION OF PROSECUTION -- ANALYSIS ON MULTI SHIELD Defendant: Dr. Robert E. Sacher, doing business as Ressel Scientific Company, Weston, Massachusetts. Charges and Disposition: Dr. Sacher pleaded guilty to one count of a three- count indictment that was handed up by a federal grand jury on Nov. 20, 1991. Dr. Sacher entered his plea to count three, charging him with obstruction of an FDA administrative proceeding by performance of a fraudulent demonstration of an analysis on Multi Shield before FDA scientists and investigators. The maximum penalties facing Dr. Sacher are five years imprisonment and a fine of $250,000. Sentencing for Dr. Sacher is scheduled for June 1, 1992. This joint investigation was done by the Food and Drug Administration and the Office of the Inspector General of the Department of Defense. Filed: April 6, 1992 -- U.S. District Court for the District of Massachusetts; Criminal number 91-10310-K, FDC number 66143.

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