Skip to content
Recall Observatory FDA recall evidence

Drug 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

D-736-2014

November 01, 2013

Class II

Product summary

Firm
Sigma-Tau Pharmaceuticals, Inc.
Event
Event 66741
Status
Terminated
Classification
Class II
Quantity
7479 vials
Official record key
drug-enforcement:D-736-2014

Official wording

Reason: 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.

Code information: Lot# 3012A, 3013A, 30138, Exp. 11/13 Lot# 3014A, 3014A CLIN, Exp. 12/13

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility