(KPLC) - Mylan Institutional LLC. is voluntary recalling of two lots of Levoleucovorin Injection, 250 mg/25 mL due to the presence of particulate matter, according to the FDA.
During a 12-month stability test, it was discovered that the products could be affected by matter identified as copper salts, FDA says. Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences such as 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, says the FDA. It’s also used in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients with advanced metastatic colorectal cancer.
Here are the affected products:
- 67457-601-30 Levoleucovorin Injection 250 mg/25 mL 24 mL vial APB032April 2019
- 67457-601-30 Levoleucovorin Injection 250 mg/25 mL 25 mL vial APB033April 2019
Mylan has notified its distributors and customers by letter and is arranging for return of all recalled products.
FDA says this product is distributed nationwide. Mylan has not received any reports of adverse events related to this recall.
See the full report HERE.