Reported Aug 25, 2021 · Terminated

Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc.…

Teva Pharmaceuticals USA

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Teva Pharmaceuticals USA · 400 Interpace Pkwy · Parsippany, NJ · 07054-1120

Is this the product you have?

  • Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01
Lot codes and dates
    • Lot #: 31325852B
    • 31325985B
    • exp. date 10/2021
    • 31326349B
    • exp. date 01/2022
    • 31326873B
    • exp. date 03/2022
    • 31326995B
    • exp. date 05/2022 31327158B
    • exp. date 06/2022
    • 31328946B
    • 31329180B
    • exp. date 05/2023
Amount recalled
434,229 vials

This recall covers 19 products

The agency filed one notice per product. You are reading one of them; the other 18 are below.

6 more are in the archive.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Lack of Assurance of Sterility

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 4, 2024 · Data as of Sep 19, 8:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.