FDA recall D-0630-2023

Astral SteriTech Private Ltd. · Class II · drug

Product

Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-079-02

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2023-05-15
Report date
2023-05-24
Termination date
2024-04-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Vadodara, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0630-2023