Drug product
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx Only, TEVA Parenteral Medicines, Inc. Irvine, CA 92618 NDC 0703-4502-04
D-0377-2021
Product summary
- Event
- Event 87875
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,138/25 single use vials per tray
- Official record key
drug-enforcement:D-0377-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot # 31325459B, exp. date 08/2021
Distribution pattern: Product was distributed nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility