D-0297-2021 Class II Terminated
FDA drug recall D-0297-2021 was initiated by Teva Pharmaceuticals USA on February 15, 2021 and is designated Class II. Reason for recall: Chemical contamination; Unknown brown residue adhering to the inside of one vial. The recall status is terminated (terminated August 26, 2021). Affected quantity: 9,452 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 10, 2021
- Initiation Date
- February 15, 2021
- Termination Date
- August 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,452 cartons
Product Description
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceuticals, USA, Inc., Parsippany, NJ Vial NDC 0703-4502-01 (vial) NDC# 0703-4502-04 (tray)
Reason for Recall
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Distribution Pattern
Nationwide, including Puerto Rico
Code Information
Lot # 31325335B, exp. date 07/2021