Levoleucovorin Injection Recalled
March 19, 2019 – Mylan Institutional LLC has voluntarily recalled two lots of Levoleucovorin Injection, 250mg/25mL, due to the presence of copper salt particulate matter. If used, the product could cause 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 use in combination chemotherapy with 5-fluorouracil in the palliative treatment of patients who have advanced metastatic colorectal cancer.
The affected products belong to lots APB032 and APB033, and expire in April 2019. Mylan has not received reports of any adverse events as of the date of recall. Patients whose product may have been recalled should contact Stericycle at 1-866-551-2706 to arrange a return. Questions can be directed to Mylan Customer Relations at 1-800-796-9526 or firstname.lastname@example.org. Patients should report any adverse events to their healthcare provider. These events can also be reported to the FDA’s MedWatch program.
Further recall details can be found at: https://www.fda.gov/Safety/Recalls/ucm633784.htm
Our mail order facility, Benecard Central Fill was not impacted by the recall.