Drug recall D-0277-2021
Product
Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tray (NDC 0703-4502-04), Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618.
Reason for recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Lots and codes
Lot # 31325042B, exp. date 06/2021 31325336B, exp. date 07/2021 31326042B, exp. date 10/2021 31326137B, exp. date 11/2021 31326230B, exp. date 12/2021 31323816B, exp. date 02/2021
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Quantity
- 29,357 vials
- Distribution
- Product was distributed nationwide in the USA and Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 10, 2021
- Terminated
- May 15, 2024
Related products
- Metoclopramide – drug information
- NDC 0703-4502 Metoclopramide · Metoclopramide Hydrochloride 5 mg/mL · Teva Parenteral Medicines, Inc.