Astral SteriTech Private Ltd.: Drug Recall

Recall #D-0603-2023 · 05/15/2023

Class II: Risk

Recall Details

Recall Number
D-0603-2023
Classification
Class II
Product Type
Drug
Recalling Firm
Astral SteriTech Private Ltd.
Status
Terminated
Date Initiated
05/15/2023
Location
Vadodara, N/A, India
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23,187 bottles

Reason for Recall

Lack of Assurance of Sterility

Product Description

Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-083-01

Distribution Pattern

Nationwide within the United States

Other Recalls by Astral SteriTech Private Ltd.

View all recalls by Astral SteriTech Private Ltd. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.