Home / Recalls / Sigma-Tau Pharmaceuticals, Inc. / D-736-2014

D-736-2014 Class II Terminated

Recalled by Sigma-Tau Pharmaceuticals, Inc. — Gaithersburg, MD

Recall Details

Product Type
Drugs
Report Date
January 22, 2014
Initiation Date
November 1, 2013
Termination Date
December 18, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7479 vials

Product Description

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

Reason for Recall

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.

Distribution Pattern

Nationwide

Code Information

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