Apotex Inc. recalls Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: H…

Recall date

May 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0840-2018

FDA classification

Class I

Brand / firm

Apotex Inc.

Sold / distributed

Nationwide in the USA.

Why it was recalled

Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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