Sandoz Recalls Methotrexate Contaminated With Particulates

May 22, 2013

Sandoz has announced a voluntary recall of two lots of its injectable methotrexate sodium, after finding particulates in vials in a routine quality examination.

The FDA has announced that Sandoz is conducting a voluntary nationwide recall of two lots of its 25 mg/ml 40 mL injectable methotrexate sodium product, after finding particulates in vials during routine quality tests. Parenteral injection of the contaminated product could lead to microembolization, which would not be expected to cause symptoms.

Sandoz reports it has not heard of any related adverse events to date.

The lot numbers are CL0996 (expiration date 12/2013) ande CJ4948 (expiration date 05/2013).

To discuss concerns or report related adverse events, contact the Sandoz Drug Information Direct Line 24/7 or email qa.druginfo@sandoz.com.

Click here to read the FDA Medwatch Alert with a link to the recall notice.