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FDA RECALLS & COURT ACTIONS: May 26, 1993

Executive Summary

CLASS II UPDATE - Diazepam Injection, USP 5 mg/ml, and Cyanocobalamin Injection, 1,000 mcg/ml, Recall number: D-208/209-3, Manufacturer: Steris Laboratories, which appeared in the April 14, 1993 "Enforcement Report" ("The Pink Sheet" April 19, T&G-14) involves products distributed under the H. L. Moore label only. CLASS III - BULK GUAIFENENSIN USP In 50 or 50.6 kg fiber drums. Recall number: D-268-3. Lot numbers range between 22766 and 30921. Manufacturer: B.I. Chemical Corporation, Petersburg, Virginia. Recalled by: Manufacturer, by letter April 16 and 26, 1993. Firm-initiated recall ongoing. Distribution: Midwest and east coast; 157,063 kg were distributed Reason: Presence of aluminum particles.

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