Mylan announced that it is expanding a voluntary recall of multiple injectable products to the hospital/user level due to the presence of visible foreign particulate matter.
The recall was initiated after visible foreign particulate matter was observed during testing of retention samples. The injection of foreign particulate matter may result in damage and/or obstruction of blood vessels which could induce emboli, particularly in the lungs or lead to arterial emboli and result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function or tissue necrosis. Additional adverse effects include local inflammation, phlebitis, allergic response and/or embolization in the body and infection and damage to blood vessels in the distal extremities or organs, foreign-body inflammatory response, with local pain, swelling and possible long term granuloma formation from intra-arterial administration.
The affected products are the following:
- Gemcitabine for Injection 200mg
- Gemcitabine for Injection 1g
- Gemcitabine for Injection 2g
- Methotrexate Injection 25mg/mL
Gemcitabine is an intravenously administered product indicated for the treatment of ovarian cancer, breast cancer, non-small cell lung cancer (NSCLC), and pancreatic cancer. Methotrexate can be administered intramuscularly, intravenously, intra-arterially, or intrathecally and is indicated for certain neoplastic diseases, severe psoriasis and adult rheumatoid arthritis.
The affected lots are available on the FDA website. Mylan is notifying its distributors and customers and is arranging for return of all recalled products. Distributors, retailers, hospitals, clinics, and physicians that have these products which are being recalled should stop use and return to place of purchase.
For more information call (888) 463-6332 or visit FDA.gov.