FDA-Drug2021-05-26Class II
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 UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-5145-91 (Novaplus, a registered trademark of Vizient, Inc.)
Teva Pharmaceuticals USA
Hazard
Lack of Assurance of Sterility
Sold states
Product was distributed nationwide.
Affected count
192,277 cartons/1 single dose vial per carton
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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 UNDER: NOVAPLUS, Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0703-5145-91 (Novaplus, a registered trademark of Vizient, Inc.)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0374-2021Don't want to check this manually?
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