March 05, 2021
Teva Pharmaceuticals USA is recalling nearly a million vials of leucovorin calcium for injection over sterility concerns. According to the March 3, 2021, US Food and Drug Administration (FDA) Enforcement Report, “Manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery, leading to a lack of sterility assurance for these sterile injectable products.”
The recall affects the following products, which were distributed throughout the United States and in Puerto Rico:
leucovorin calcium for injection (NDC 0703-5140-01), 100 mg/vial, single-dose vial, Teva Parenteral Medicines Inc., Irvine, CA, from lots 31326364B (Exp. 1/22), 31327120B (Exp. 5/22), and 31327963B (Exp. 10/22);
leucovorin calcium for injection, 350 mg/vial (NDC 0703-5145-01), labeled as Teva Parenteral Medicines Inc., Irvine, CA, from lots 31324653B (Exp. 3/21), 31326066B (Exp. 11/21), 31326428B (Exp. 2/22), 31327949B (Exp. 10/22), 31327995B (Exp. 10/22), 31328031B (Exp. 11/22), 31328217B (Exp. 12/22), 31328325B (Exp. 12/22), 31328425B (Exp. 7/21); and
leucovorin calcium for injection, 350 mg/vial (NDC 0703-5145-01), labeled as manufactured by Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, Novaplus, from lots 31324480B (Exp. 2/21) and 31327396B (Exp. 8/22).
Teva Pharmaceuticals voluntarily initiated the recall February 10, 2021. On February 21, 2021, the FDA designated the recall Class II, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.
A reduced folic acid, leucovorin is a prescription medication used to prevent the side effects of the cancer drug methotrexate, to treat anemia caused by a lack of folic acid, and is sometimes used with the cancer drug fluorouracil to treat colon cancer.