FDA Recall D-0839-2018

Apotex Inc.

Class I — life-threatening Terminated 1974 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 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4

Lot / code: Lots: 501G014 Exp. 05/2018; 501G015 Exp.09/2018; 501G016, 501G017, 501G018, 501G019, 501G020, 501G021, 501G022, 501G023 Exp. 10/2018; 501G024, 501G025, 501G026, 501G027, 501G028, 501G029 501G030, Exp. 11/2018, 501H001, 501H002, 501H003, 501H004, 501H005, 501H006, 501H007, 501H008, Exp. 12/2018; 501H009, Exp. 04/2019; 501H012, 501H013 Exp. 06/2019; 501H018, 501H019, Exp. 09/2019.

Quantity: 121693 vials

Reason for recall

Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Recall record

Recall number: D-0839-2018
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA.
Recall initiated: 2018-05-08
Classified by FDA Center: 2018-06-05
FDA published: 2018-05-23
Terminated: 2023-10-03
Recalling firm: Apotex Inc.

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