Sandoz initiates voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Methotrexate Injection, USP due to the presence of glass particulates

Sandoz initiates voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Methotrexate Injection, USP due to the presence of glass particulates
Thu, 28 Oct 2010 13:33:00 -0500

Sandoz Inc. announced today it has initiated a voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product (“methotrexate”) to the consumer/user level. Consistent with its commitment to quality and patient safety, Sandoz is initiating this voluntary recall of all 24 lots of the affected product following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots. The flakes are the result of delamination of the glass used to manufacture the vials of these two dosage presentations.

---

Manage your FDA Subscriptions:

• Update your preferences or unsubscribe
• Questions about this service? support@govdelivery.com
• Other inquiries? webmail@oc.fda.gov

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420