RecallRadar

FDA Drug recall D-0840-2018

Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare In…

On 2018-05-23 the FDA classified a Class I recall of Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare In… by Apotex, citing subpotent Drug: High Levels of Impurities Resulting in Decrease Potency.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0840-2018
ClassificationClass I
Statusterminated
Initiated2018-05-08
Published2018-05-23
Last updated2026-09-13 11:52 UTC
CompanyApotex
DistributionUS

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

Reason

Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0840-2018%22

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