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November 30, 1999

Helm New York, Inc. Streptomycin Sulfate Recalled

Piscataway, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Helm New York, Inc. is recalling Streptomycin Sulfate, USP, bulk, in 5 kg fiber drums, Rx for manufacturing use only, because of good manufacturing practice deviations at the Long March Pharmaceutical Plant.

This ongoing Class III recall was initiated by the company, between September 8 and 16, 1999 by telephone.  This is the first notice the FDA has issued to the general public of the recall.

Over 780 kg were distributed in New York, New Jersey, Ohio, Missouri, Arkansas, North Carolina, Iowa and California and bear the lot numbers SC-SM980802, SC-SM 980701, SC-SM980203, SC-SM980204 or SC-SM980205.   The firm estimated that 25 kg remained on market at time of recall initiation.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

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