FDA-Drug2021-08-25Class II

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

Teva Pharmaceuticals USA
Hazard

Lack of Assurance of Sterility

Sold states
Product was distributed Nationwide, including Puerto Rico.
Affected count
434,229 vials
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0737-2021

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