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Recall Observatory FDA recall evidence

Drug 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.

D-0277-2021

February 10, 2021

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 87298
Status
Terminated
Classification
Class II
Quantity
29,357 vials
Official record key
drug-enforcement:D-0277-2021

Official wording

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.

Code information: 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

Distribution pattern: Product was distributed nationwide in the USA and Puerto Rico.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility