Mylan is expanding its voluntary nationwide recall to the hospital/user level of select lots of the following injectable products due to the presence of visible foreign particulate matter observed during testing of retention samples.
| NDC Number | Product Name and Strength | Package Size | Lot Number | Expiration Date |
|---|
| 0069-3857-10 |
Gemcitabine for Injection, USP 200 mg |
10 mL |
7801084 |
07/2015 |
| 0069-3857-10 |
Gemcitabine for Injection, USP 200 mg |
10 mL |
7801110 |
08/2015 |
| 67457-463-02 |
Gemcitabine for Injection, USP 2 g |
100 mL |
7801221 |
03/2016 |
| 67457-464-20 |
Gemcitabine for Injection, USP 200 mg |
10 mL |
7801398 |
08/2016 |
| 67457-464-20 |
Gemcitabine for Injection, USP 200 mg |
10 mL |
7801406 |
08/2016 |
| 67457-464-20 |
Gemcitabine for Injection, USP 200 mg |
10 mL |
7801427 |
09/2016 |
| 67457-462-01 |
Gemcitabine for Injection, USP 1 g |
50 mL |
7801284 |
05/2016 |
| 67457-467-99 |
Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL) |
5 x 2 mL |
7801421 |
09/2016 |
Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. Intrathecal administration could result in a life threatening adverse event or result in permanent impairment of a body function. Intravenous administration has the potential to damage and/or obstruct blood vessels which could induce emboli, particularly in the lungs. If a right to left cardiac shunt is present, the particulate may lead to arterial emboli and result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function or tissue necrosis. Other adverse effects associated with intravenous injection of particulate matter include local inflammation, phlebitis, allergic response and/or embolization in the body and infection. Intra-arterial administration could result in damage to blood vessels in the distal extremities or organs. Intramuscular administration could result in foreign-body inflammatory response, with local pain, swelling and possible long term granuloma formation. To date, Mylan has not received any reports of adverse events related to this recall.
Gemcitabine for Injection, USP is an intravenously administered product indicated for the treatment of ovarian cancer, breast cancer, non-small cell lung cancer and pancreatic cancer. These lots were distributed in the U.S. between January 8, 2014, and February 10, 2015, and were manufactured and packaged by Agila Onco Therapies Limited, a Mylan company. Lot 7801084 and 7801110 are packaged with a Pfizer Injectable label.
Methotrexate Injection, USP 25 mg/mL can be administered intramuscularly, intravenously, intra-arterially, or intrathecally and is indicated for certain neoplastic diseases, severe psoriasis and adult rheumatoid arthritis. The lot was distributed in the U.S. between December 8, 2014, and December 19, 2014, and was packaged by Agila Onco Therapies Limited, a Mylan company.
Mylan is notifying its distributors and customers by letter 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.