Mylan Institutional LLC Recalls Levoleucovorin Injection

March 19, 2019

The company is recalling Levoleucovorin Injection, 250 mg/25 mL because of copper salts found during stability testing.

Mylan Institutional LLC announced on March 18, 2019 that it was recalling two lots of Levoleucovorin Injection, 250 mg/25 mL manufactured by Alidac Pharmaceuticals Limited and distributed by Mylan Institutional LLC. The recall was initiated after 12 months of stability testing found particulate matter identified as copper salts.

The recalled Levoleucovorin Injection, 250 mg contains 25 mL sterile solution in a single-use vial packaged in a carton containing one single-use vial. The batches were distributed in the United States between August 2017 and July 2018.

While the company has not, to date, received any reports of adverse events related to the recall, it warns that administration of drug product containing foreign particulates may cause local irritation, vasculitis/phlebitis, antigenic or allergic reactions, and microvascular obstruction, including pulmonary embolism. 

According to the company, 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.”

Source: FDA