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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Detail

Product Description Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0.
Recall Number D-806-2013
Classification Class I
Code Info Lot #: 503B015, 503B016, Exp 04/13; 503B019, 503B020, 503B021, 503B022, Exp 07/13; 503B024, Exp 08/13; 503B025, 503B026, 503B027, Exp 09/13; 503C005, 503C006, Exp 12/13; 503C007, 503C008, Exp 01/14; 503C018, Exp 04/14
Product Distributed Qty 37,303 vials
Reason For Recall Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.

Event Detail

Event Id 64657
Product Type Drugs
Status Ongoing
Recalling Firm Apotex Corp.
City Weston
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide