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FDA RECALLS & COURT ACTIONS: Oct. 27, 1993

Executive Summary

CLASS II -- DECLOMYCIN HCL CAPSULES 150 mg, in bottles of 100, Rx antibiotic. Recall number: D-010-4. Control numbers: 280-446 EXP March 1995, 297-437 EXP June 1995. Manufacturer: LederLe Labs, Pearl River, New York. Recalled by: Manufacturer, by letter Sept. 30, 1993. Firm-initiated recall ongoing. Distribution: California, Illinois, Pennsylvania, Texas, Puerto Rico; 10,396 bottles were distributed. Reason: Product does not meet dissolution specifications through expiration date. CLASS II -- TRENTAL (PENTOXIFYLiNE) 400 MG TABLETS In bottles of 100, Rx indicated for the treatment of patients with intermittent claudication. Recall number: D-009-4. Lot Number/Expiration Date: 078-566-1/April 1994; 078-568-1/April 1994; 078-569-1/April 1994; 078-572-1/April 1994; 078-2-04-2/November 1994; 078-201-2/November 1994; 078-250-Z/November 1994; 078-244- 2/November 1994; 078-416-2/January 1995; 078-423-Z/February 1995; 078-424-2/February 1995; 078-428-2/February 1995; 078-438-Z/February 1995; 078-445-2/February 1995; 078-449-2/February 1995; 078-464- Z/February 1995; 078-465-2/February 1995; 078-466-2/February 1995; 078-468-2/February 1995; 078-469-2/February 1995; 078-470-2/February 1995; 078-476-2/February 1995; 078-477-Z/February 1995; 078-480- 2/March 1995; 078-481-2/March 1995; 078-482-2/March 1995; 078-484- Z/March 1995; 078-485-2/March 1995; 078-486-2/March 1995; 078-487- 2/March 1995; 078-489-2/March 1995; 078-735-2/April 1995; 078-740- 2/April 1995. Note: The 2 lot numbers 078-201-2 and 078-244-2, are the 2 lot numbers included in the Aug. 30, 1993 recall extension. Manufacturer: Hoechst-Roussel Pharmaceuticals, Inc., Somerville, New Jersey. Recalled by: Manufacturer, by letters of June 22, 1993 and Aug. 30, 1993. Firm-initiated recall complete. Distribution: Nationwide. Reason: Product does not meet sustained-release specifications.
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