Methotrexate Injection USP 50 mg/2 mL - Voluntary Recall Due to the Potential Presence of Foreign Particulate Matter

The company has initiated this recall due to the presence of particulate matter observed in one vial from this lot of Methotrexate Injection USP 50 mg/2 mL. Presence of foreign particulate matter in vials of the affected lot could pose the following risks, if injected by intravenous or intra-arterial routes: local inflammation, phlebitis, allergic response and/or embolization in the body. This is the only lot of Methotrexate that has been distributed by Mylan. No complaints or adverse event reports have been received in relation to this product.

Product safety