Drug maker Sandoz recalls methotrexate injection vials over possible glass flakes

German drug maker Sandoz on Thursday announced a recall of two sizes of methotrexate injection vials sold under the Sandoz and Parenta brands because of the possible presence of glass flakes.

“While it is unlikely,” injection of the drug from affected vials “could lead to serious adverse events, resulting in disability and death,” Sandoz said in a statement, which also recommended that patients immediately stop use of the affected product.

The flakes resulted from delamination of glass used to make the 50 mg and 250 mg vials of the drug. Sandoz said that so far it has not received any reports of adverse events or product complaints connected to the flaking, including in vials from lots in which the particles were found.

Methotrexate is an anti-metabolite -- it slows the growth of certain kinds of cells -- and is used to treat severe cases of psoriasis and rheumatoid arthritis, as well as leukemia, breast cancer and other cancers. It can cause serious, sometimes fatal toxic reactions and is generally a treatment of last resort.


The recall covers 24 lots, including four lots in which the flakes were detected. The company statement did not explain how many vials were in the lots and a Sandoz spokesman did not immediately respond to an e-mail message seeking more information.

Click here to read the recall notice.