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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

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
Recall Number D-736-2014
Classification Class II
Code Info Lot# 3012A, 3013A, 30138, Exp. 11/13 Lot# 3014A, 3014A CLIN, Exp. 12/13
Product Distributed Qty 7479 vials
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.

Event Detail

Event Id 66741
Product Type Drugs
Status Ongoing
Recalling Firm Sigma-Tau Pharmaceuticals, Inc.
City Gaithersburg
State MD
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-11-01
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Nationwide