D-0623-2023 Class II Terminated

Recalled by Astral SteriTech Private Ltd. — Vadodara, N/A

FDA drug recall D-0623-2023 was initiated by Astral SteriTech Private Ltd. on May 15, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated April 5, 2024). Affected quantity: 110,660 vials.

Recall Details

Product Type
Drugs
Report Date
May 24, 2023
Initiation Date
May 15, 2023
Termination Date
April 5, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
110,660 vials

Product Description

Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-002-31

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide within the United States

Code Information

All lots within expiry.