Astral SteriTech Private Ltd.: Drug Recall

Recall #D-0588-2023 · 05/15/2023

Class II: Risk

Recall Details

Recall Number
D-0588-2023
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
220,340 vials

Reason for Recall

Lack of Assurance of Sterility

Product Description

Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-087-02

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.