Mylan is expanding its voluntary U.S. recall of select lots of injectable products due to the presence of visible foreign particulate matter observed during testing.
The two meds include Gemcitabine for Injection, indicated for the treatment of ovarian, breast, non-small cell lung, and pancreatic cancers and Methotrexate Injection, also used in cancer treatment, as well as severe psoriasis and adult rheumatoid arthritis.
Recalled lots were distributed in the U.S. and were manufactured and packaged by Mylan's Agila Onco Therapies. Select lots were manufactured for Pfizer.
To date, Mylan says it has not received any reports of adverse events related to this recall.
Read the FDA recall notice