November 30, 1999Helm New York, Inc. Streptomycin
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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