FDA Recall D-835-2013

Apotex Corp. · Weston, FL

Class I — life-threatening Terminated 1704 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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 / code: 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

Quantity: 52,398 vials

Reason for recall

Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.

Recall record

Recall number: D-835-2013
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2013-05-10
Classified by FDA Center: 2013-08-02
FDA published: 2013-08-14
Terminated: 2018-01-08
Recalling firm: Apotex Corp.
Firm location: Weston, FL

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