Drug product
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)
D-0297-2021
Product summary
- Event
- Event 87330
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,452 cartons
- Official record key
drug-enforcement:D-0297-2021
Official wording
Reason: Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Code information: Lot # 31325335B, exp. date 07/2021
Distribution pattern: Nationwide, including Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
Chemical contamination