Leucovorin Calcium for Injection recalled over sterility concerns
- Recall date
- July 29, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Teva Pharmaceuticals USA recalls Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irv…
- Recall number
- D-0746-2021
- FDA classification
- Class II
- Brand / firm
- Teva Pharmaceuticals USA
- Sold / distributed
- Product was distributed Nationwide, including Puerto Rico.
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01
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