FDA recall D-0839-2018

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 for recall

Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2018-05-08

Report date

2018-05-23

Termination date

2023-10-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

North York, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0839-2018