Teva Pharmaceuticals USA recalls Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg/mL), Rx Only, FOR IM or IV Use, Sterile, T
Recalled May 26, 2021 · FDA recall D-0374-2021 · Teva Pharmaceuticals USA
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
192,277 cartons/1 single dose vial per carton
Sold at
Product was distributed nationwide.
Description
Lack of Assurance of Sterility
Product
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.)
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →