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

Recall Number: D-736-2014

Firm: Sigma-Tau Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20140122

Initiation Date: 20131101

Termination Date: 20141218

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.

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