Recalls / Class II
Class IID-0741-2021
Product
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
- Brand name
- Metoclopramide
- Generic name
- Metoclopramide
- Active ingredient
- Metoclopramide Hydrochloride
- Route
- Intramuscular, Intravenous
- NDC
- 0703-4502
- FDA application
- ANDA073135
- Affected lot / code info
- Lot #: 31326043B, exp. date 10/2021; 31326138B, exp. date 11/2021 31329399B, 31329539B, exp. date 08/2023; 31329599B, exp. date 09/2023
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Parenteral Medicines, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 25,653 vials
- Distribution pattern
- Product was distributed Nationwide, including Puerto Rico.
Timeline
- Recall initiated
- 2021-07-29
- FDA classified
- 2021-08-16
- Posted by FDA
- 2021-08-25
- Terminated
- 2024-06-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0741-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.