November 30, 1999Helm New York,
Inc. Gentamicin Sulfate Recalled
Piscataway, NJ (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Helm New York, Inc. is recalling Gentamicin
Sulfate, USP, distributed in bulk and in 50 kg fiber drums and used for manufacturing use
only, because of good manufacturing practice deviations at Long March Pharmaceutical
manufacturing site in China.
This ongoing Class II recall was initiated by
the company, September 8 and 16, 1999, by telephone followed by letter. This is the
first notice the FDA has issued to the general public of the recall.
Although 26,953 kg. were distributed
in Missouri, New York, Illinois, California, New Jersey, Iowa, Iowa, Arizona, and Ohio the
firm estimated that 1,500 kg. remained on market at time of recall initiation. The recall
affects all lots with prefix SC-GM 96, SC-GM 97, SC-GM 98 and SCGM99.
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
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