RecallRadar

FDA Drug recall D-0839-2018

Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare…

On 2018-05-23 the FDA classified a Class I recall of Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare… by Apotex, citing subpotent Drug: High Levels of Impurities Resulting in Decrease Potency.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0839-2018
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 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

Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Identifiers

code_info
Lots: 501G014 Exp. 05/2018; 501G015 Exp.09/2018; 501G016, 501G017, 501G018, 501G019, 501G020, 501G021, 501G022, 501G023…Lots: 501G014 Exp. 05/2018; 501G015 Exp.09/2018; 501G016, 501G017, 501G018, 501G019, 501G020, 501G021, 501G022, 501G023 Exp. 10/2018; 501G024, 501G025, 501G026, 501G027, 501G028, 501G029 501G030, Exp. 11/2018, 501H001, 501H002, 501H003, 501H004, 501H005, 501H006, 501H007, 501H008, Exp. 12/2018; 501H009, Exp. 04/2019; 501H012, 501H013 Exp. 06/2019; 501H018, 501H019, Exp. 09/2019.

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-0839-2018%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.