Mylan is recalling 2 lots of Levoleucovorin Injection 250mg/25mL due to the presence of copper salts identified during 12-month stability testing.
The recalled products, packaged as single-use 25mL vials, have lot numbers APB032 and APB033; both have an expiration date of April 2019.
At this time no reports of adverse event related to this recall have been received. Administration of an injectable that contains foreign particulates could potentially lead to severe health consequences (i.e., vasculitis/phlebitis, antigenic or allergic reactions, microvascular obstruction).
Levoleucovorin Injection is indicated for: rescue after high-dose methotrexate therapy in osteosarcoma; diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination; and treatment of patients with metastatic colorectal cancer in combination with fluorouracil.
For more information visit Mylan.com.