Class I Recall Issued for Injection

A Class I recall has been issued for two lots of levoleucovorin injection over the presence of particular matter, identified as copper salts, in the vials, according to the March 20, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects levoleucovorin injection, 250 mg/25 mL (10 mg/mL), 25-mL single-use vials manufactured by Mylan Institutional (NDC 67457-601-30) from lots APB032 and APB033 (Exp. 4/19). The recalled vials were distributed throughout the United States. 

Mylan Institutional voluntarily initiated the recall February 1, 2019, which the FDA subsequently designated Class I. The classification warns use of the affected product could cause serious adverse health consequences or death. 

Levoleucovorin injection is available with a prescription to prevent the harmful effects of methotrexate used in cancer treatment. It can also treat overdose of methotrexate or similar drugs.

 —Jolynn Tumolo