FDA Recall D-0840-2018

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 4.5 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 60505-0688-4

Lot / code: Lots: 502H001 Exp. 01/2019; 502H003, 502H004, 502H005, Exp. 04/2019; 502H009, 502H012, Exp. 05/2019.

Quantity: 13453 vials

Reason for recall

Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Recall record

Recall number: D-0840-2018
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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