October 25, 2019
Ingenus Pharmaceuticals is recalling several lots of leucovorin calcium injection due to the presence of particulate matter identified as crystallization of an active pharmaceutical ingredient, according to the October 23, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 16,485 single-dose vials of leucovorin calcium injection, 500 mg/50 mL (10 mg/mL), 50 mL (NDC 50742-464-50), from lots 18048 (Exp. 4/20), 18049 (Exp. 4/20), 18050 (Exp. 5/20), and 19036 (Exp. 12/20). The vials were distributed throughout the United States.
Ingenus Pharmaceuticals initiated the recall October 9, 2019. On October 17, 2019, the FDA designated the recall Class II. Under Class II recalls, use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
Leucovorin calcium is a form of folic acid prescribed to prevent side effects from large doses of medications, such as some chemotherapy drugs, that reduce the effects of folic acid in the body.