FDA Recall D-806-2013

Apotex Corp. · Weston, FL

Class I — life-threatening Terminated 1757 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 #: 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

Quantity: 37,303 vials

Reason for recall

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

Recall record

Recall number: D-806-2013
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2013-03-18
Classified by FDA Center: 2013-07-17
FDA published: 2013-07-24
Terminated: 2018-01-08
Recalling firm: Apotex Corp.
Firm location: Weston, FL

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