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

FDA recall notice · announced May 23, 2018 · Apotex

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

Reason for recall

Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lots: 502H001 Exp. 01/2019; 502H003, 502H004, 502H005, Exp. 04/2019; 502H009, 502H012, Exp. 05/2019.
Quantity: 13453 vials
Status: Terminated
Products in this recall event:
- 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: Apot (D-0839-2018)
- 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 (D-0840-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.