Reported May 26, 2021 · Terminated

Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile,…

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, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, Teva Parenteral Medicines, Inc., Irvine, CA NDC 0703-5145-01
  • ALSO LABELED UNDERNOVAPLUS
  • Manufactured ByTeva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-5145-91 (Novaplus, a registered trademark of Vizient, Inc.)
Lot codes and dates
  • NDC 0703-5145-01
    • Lot # 31325332B
    • exp. date 08/2021
    • Lot # 31325756B
    • exp
  • date 09/2021 AND NDC 0703-5145-91
    • Lot # 31325685B
    • exp. date 09/2021
Amount recalled
192,277 cartons/1 single dose vial per carton

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Where it was sold

  • Nationwide

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, 5:07 PM UTC

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