Mylan is conducting a voluntary nationwide recall of two lots of Levoleucovorin Injection, 250 mg/25 mL tothe consumer/user level. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC. The Levoleucovorin Injection is being recalled due to the presence of particulate matter identified as copper salts. The particulate matter was discovered during 12-month stability testing.
Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. Intravenous administration of a solution containing particulates could lead to local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. To date, Mylan has not received any reports of adverse events related to this recall.
Levoleucovorin injection is indicated for rescue after high-dose Methotrexate therapy in osteosarcoma; for diminishing the toxicity and counteracting the effects of impaired Methotrexate elimination and of inadvertent overdose of folic acid antagonists; and for the use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.
Levoleucovorin Injection, 250 mg contains 25 mL sterile solution in a single-use vial.
Mylan has notified its distributors and customers by letter and is arranging for return of all recalled products.
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