FDAFDA · Food and drugs·Recall number D-0277-2021
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.
Published March 3, 2021 · Recall initiated: February 10, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- METOCLOPRAMIDE
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Product was distributed nationwide in the USA and Puerto Rico.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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