Two lots of levoleucovorin injection manufactured by Alidac Pharmaceuticals and distributed by Mylan were voluntarily recalled, after the presence of copper salts were identified as the particulate matter within the drug.
Copper salts were found to be present during 12-month stability testing of the injection.
Administration of a sterile injectable with foreign particulates has the potential to cause severe health consequences.
Levoleucovorin injection is indicated as a rescue treatment after high-dose methotrexate therapy in osteosarcoma, as well as for diminishing the toxicity and counteracting the effects of inadvertent overdose of folic acid antagonists.
While intravenous administration of a sterile injection with foreign particulates could lead to microvascular obstruction, antigenic or allergic reactions, or pulmonary embolism, Mylan has not received any reports of adverse events related to this recall.
In 2015, Mylan recalled eight lots of sterile injectables when foreign particulate matter was found during testing. The products recalled in 2015 included the chemotherapy treatments, gemcitabine, carboplatin, and cytarabine, which were manufactured by Agila Onco Therapies.
The 2015 recall was expanded to include batches of methotrexate after finding visible particulates in the IV drug.