PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: May 23, 2018 Initiated: May 8, 2018 #D-0839-2018

Product Description

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

Reason for Recall

Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Details

Recalling Firm
Apotex Inc.
Units Affected
121693 vials
Distribution
Nationwide in the USA.
Location
North York

Frequently Asked Questions

What product was recalled?
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. Recalled by Apotex Inc.. Units affected: 121693 vials.
Why was this product recalled?
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Which agency issued this recall?
This recall was issued by the FDA Drug on May 23, 2018. Severity: Critical. Recall number: D-0839-2018.