D-0741-2021 Class II Terminated

Recalled by Teva Pharmaceuticals USA — Parsippany, NJ

FDA drug recall D-0741-2021 was initiated by Teva Pharmaceuticals USA on July 29, 2021 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated June 4, 2024). Affected quantity: 25,653 vials.

Recall Details

Product Type
Drugs
Report Date
August 25, 2021
Initiation Date
July 29, 2021
Termination Date
June 4, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25,653 vials

Product Description

Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Product was distributed Nationwide, including Puerto Rico.

Code Information

Lot #: 31326043B, exp. date 10/2021; 31326138B, exp. date 11/2021 31329399B, 31329539B, exp. date 08/2023; 31329599B, exp. date 09/2023