Astral SteriTech Private Ltd.: Drug Recall

Recall #D-0601-2023 · 05/15/2023

Class II: Risk

Recall Details

Recall Number: D-0601-2023
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: 119,340 vials

Reason for Recall

Lack of Assurance of Sterility

Product Description

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

Distribution Pattern

Nationwide within the United States

Other Recalls by Astral SteriTech Private Ltd.

Class II: Risk 05/15/2023

Lack of Assurance of Sterility
Class II: Risk 05/15/2023

Lack of Assurance of Sterility
Class II: Risk 05/15/2023

Lack of Assurance of Sterility
Class II: Risk 05/15/2023

Lack of Assurance of Sterility
Class II: Risk 05/15/2023

Lack of Assurance of Sterility

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.