Recall: D-0277-2021
Class II - Potentially Harmful
Class IIClassification
2021-02-10Initiated
TerminatedStatus
Teva Pharmaceuticals USAFirm
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
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.
Distribution
Product was distributed nationwide in the USA and Puerto Rico.
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.