Mylan Recalls Cancer Drug Over Particulate Matter Contamination

Drugmaker Mylan issued a voluntary recall of two lots of a cancer drug over concerns they may be contaminated with particulate matter.

During a yearlong stability test, copper salts were discovered in two lots of Levoleucovorin Injection, a drug used in cancer treatments, the Food and Drug Administration said.

Intravenous administration of the drug containing copper salts can result in things like allergic reactions, microvascular obstruction, pulmonary embolism and vein and blood vessel inflammation.

According to the FDA, Mylan has not received any reports of adverse reactions relating to the recall.

The recalled lots were manufactured by Alidac Pharmaceuticals Limited and include Levoleucovorin Injection, 250 mg/25 mL with an expiration date of April 2019 and lot numbers APB032 and APB033.

Mylan has notified its distributors and customers and is arranging for the return of affected products. The company advised wholesalers and retailers to quarantine and discontinue distribution of the affected lots and to contact customers who have already purchased the contaminated drug and notify them of the recall.

Mylan told consumers who have bought the drug were directed to contact Stericycle for information on how to properly return the product.