Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

▤ Summary

Mylan Institutional LLC is conducting a voluntary nationwide recall of two lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL to the consumer/user level. The Levoleucovorin Injection is being recalled due to the presence of particulate matter identified as copper salts. Intravenous administration of a solution containing particulates could lead to local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. 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. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.

▦ Linked Companies

Recall InfoLink

$1M to $5M