Recalls / Class II
Class IID-0297-2021
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)
- Brand name
- Metoclopramide
- Generic name
- Metoclopramide
- Active ingredient
- Metoclopramide Hydrochloride
- Route
- Intramuscular, Intravenous
- NDC
- 0703-4502
- FDA application
- ANDA073135
- Affected lot / code info
- Lot # 31325335B, exp. date 07/2021
Why it was recalled
Chemical contamination; Unknown brown residue adhering to the inside of one vial.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Parenteral Medicines, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 9,452 cartons
- Distribution pattern
- Nationwide, including Puerto Rico
Timeline
- Recall initiated
- 2021-02-15
- FDA classified
- 2021-03-03
- Posted by FDA
- 2021-03-10
- Terminated
- 2021-08-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0297-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.