PEGASPARGASE ONCASPAR Injection, 3750 International Units Per 5mL vial, Rx ONLY, sigma-tau PHARMA...
FDA Recall #D-736-2014 — Class II — November 1, 2013
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.
Recalling Firm
Sigma-Tau Pharmaceuticals, Inc. — Gaithersburg, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
7479 vials
Distribution
Nationwide
Code Information
Lot# 3012A, 3013A, 30138, Exp. 11/13 Lot# 3014A, 3014A CLIN, Exp. 12/13
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated