Pennsylvania-based generic-drug maker Mylan NV has voluntarily recalled two U.S.-distributed batches of its Levoleucovorin injection due to copper salt particles found in the drug.
The recall, initiated as a result of annual stability testing, is being conducted through the company's Illinois subsidiary Mylan Institutional Inc.
Levoleucovorin injection is used to treat toxicity associated with cancer drugs such as methotrexate and chemotherapy. The batches of 250-milligram ingredient in 25 mL vials were distributed in the U.S. between August 2017 and July 2018, according to Mylan.
No adverse events have been reported as a result of the contamination, but the presence of particulates could lead to problems such as irritation, allergic reactions and more.
The company urged wholesalers, retailers and consumers to examine their stock of the drug for the batches.
Another of Mylan's drugs, the blood pressure drug valsartan, has been among the subjects of another recall since July 2018 due to the presence of possible carcinogens in one of its ingredients originating in China.