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November 30, 1999

Helm 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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