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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Event Detail

Event ID 65196
Product Type Drugs
Status Ongoing
Recalling Firm Apotex Corp.
City Weston
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-10
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lot No. 503B023, Exp. 08/13; 503B028, 503B029, 503B030, 503B031, 503B032, 503B033, Exp. 11/13; 503C001, 503C002, 503C003, 503C004, Exp. 12/13; 503C009, Exp. 01/14; 503C010, 503C011, 503C012, 503C014, Exp. 02/14; 503C015, 503C016, 503C017, 503C019, 503C020, Exp. 04/14 Class I Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution. 52,398 vials D-835-2013