FDA recall D-0601-2023

Product

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-081-02

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-0601-2023