drugs Class II Updated 2014-01-22

Sigma-Tau Pharmaceuticals, Inc. recalls PEGASPARGASE ONCASPAR Injection, 3750 International Units Pe

Recalled Product

PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMACEUTICALS INC, 9841 Washingtonian Blvd, Gaithersburg, MD 20878 NDC 54482-301-01

Hazard / Issue

Lack of Assurance of Sterility: Sigma-Tau PharmaSource, Inc. is conducting a voluntary recall of five lots of Oncaspar Injection, because of a crack under the crimp seal which caused a leak.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot# 3012A, 3013A, 30138, Exp. 11/13 Lot# 3014A, 3014A CLIN, Exp. 12/13
View official government recall

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