Drug Safety Alerts

Levoleucovorin 250mg/25 mL single-dose vial Consumer-Level

02/01/2019

On February 1, 2019, Mylan issued a consumer-level recall of levoleucovorin 250mg/25 mL single-dose vials NDC # 67457-0601-30. This recall was issued due to the presence of particulate matter exceeding the specification. Intravenous administration of solution containing particulates could lead to local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction: including pulmonary embolism.

This recall affects lot numbers APB033 exp. 04/30/2019 and APB032 exp. 04/30/2019. 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 the diminishing the toxicity and counteracting the effects of impaired methotrexate elimination and of inadvertent overdose of folic acid antagonists: and for the use in the combination chemotherapy with 5-fluorouacil in the palliative therapy of patients with advanced metastatic colorectal cancer.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact Mylan Customer Service at 1-800-796-9526 or visit www.mylan.com.You may also contact the United States Food and Drug Administration (FDA) consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov.