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FDA RECALLS & COURT ACTIONS: June 23, 1993

Executive Summary

CLASS II - NEOMYCIN SULFATE TABLETS, 500 MG In bottles of 100, a Rx antibiotic. Recall number: D-282-3. All lots. Manufacturer: Eon Labs Manufacturing, Inc., Laurelton, New York. Recalled by: Manufacturer, by telephone and by letter June 11, 1993. Firm-initiated recall ongoing. Distribution: Nationwide; 21,000 bottles were distributed. Reason: Discrepancies in manufacturing procedures. CLASS III - (a) DONNAZYME TABLETS; (b) ENTOZYME TABLETS (a) In 100 tablet bottles, Pancreatin, USP equivalent 500 mg; (b) in 100 tablet bottles, Pancreatin, USP equivalent 300 mg. Recall number: D-280/281-3. All lots. Manufacturer: Whitehall-Robins, Richmond, Virginia. Recalled by: Manufacturer, by letter May 25, 1993. Firm-initiated recall ongoing. Distribution: Nationwide, Puerto Rico, Canada; undetermined quantity. Reason: Potency not assured through expiration date.
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