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U.S. Department of Health and Human Services

Drugs

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Recall of Pegaspargase, Oncaspar - (Enzon, Inc) - 6/12/2002

DATE RECALL INITIATED:

June 12, 2002

LOT NUMBERS / EXPIRATION DATE:

AK0129     11/1/2003
AA0201     1/1/2004
AE0114     5/1/2003
AE0115     5/1/2003
AH0120     8/1/2003

MANUFACTURER:

Enzon, Inc.
Piscataway, NJ

REASON:

The lots of Pegaspargase, Oncaspar, were recalled due to high-in-vitro enzymatic activity levels, above the label claim of 750 IU/ml +/- 20%. Additional testing was performed on all lots manufactured on or after February 13, 2002, to ensure they are currently within specification. Consignees have been asked to contact the manufacturer to arrange for product return.

 


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.