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Recall Observatory FDA recall evidence

Drug 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

D-0741-2021

July 29, 2021

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 88442
Status
Terminated
Classification
Class II
Quantity
25,653 vials
Official record key
drug-enforcement:D-0741-2021

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: 31326043B, exp. date 10/2021; 31326138B, exp. date 11/2021 31329399B, 31329539B, exp. date 08/2023; 31329599B, exp. date 09/2023

Distribution pattern: Product was distributed Nationwide, including Puerto Rico.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility