From Our 2010 Archives

RA Drug Methotrexate Is Recalled

Glass Flakes in Injectable Rheumatoid Arthritis Drug Spur Recall

By Daniel J. DeNoon
WebMD Health News

Reviewed by Laura J. Martin, MD

Oct. 28, 2010 -- Glass flakes have led to the recall of Sandoz and Parenta brand injectable methotrexate, a drug used to treat rheumatoid arthritis, cancer, and psoriasis.

The glass flakes "are the result of delamination of the glass used to manufacture the vials" of two dosages of the drug, the FDA says in a news release.

"There is the potential to develop adverse reactions in areas where the particles lodge," the FDA says. "Injection of drug from the affected lots could lead to serious adverse events, resulting in disability and death. Additionally, neurologic damage could result from intrathecal [spinal] administration."

There have been no reports of adverse events to date.

Customers and patients should immediately discontinue use of this product and patients should contact their doctor or health care provider if they experience any problem that might be related to the use of this product.

Adverse events related to the use of Sandoz methotrexate product should be reported to Sandoz at 800-525-8747 or to the FDA's MedWatch Adverse Event Reporting Program.

The recall applies to all 50 mg/2 mL and 250 mg/10 mL vials of the drugs:

Product : Methotrexate Injection, USP, 50 mg/2 mL
NDC Number : 66758-040-02 (10 vial pack) and 66758-040-01 (Individual vial)

Lot NumberLabel TypeExp Date
92395606Parenta12/2010
92760803Parenta2/2011
92965104Parenta3/2011
92965106Parenta3/2011
92965904Parenta4/2011
93255704Parenta6/2011
93502204Parenta7/2011
93635404Parenta8/2011
93681704Parenta8/2011
93794904Sandoz9/2011
95198604Sandoz10/2011
95357804Sandoz12/2011
95537704Sandoz1/2012
95987004Sandoz3/2012



Product : Methotrexate Injection, USP, 250 mg/10 mL
NDC Number : 66758-040-08 (10 vial pack) and 66758-040-07 (Individual vial)

Lot NumberLabel TypeExp Date
92395703Parenta12/2010
92760903Parenta2/2011
92965203Parenta3/2011
92966003Parenta4/2011
93255803Parenta6/2011
93502303Parenta7/2011
93635503Parenta8/2011
93795003Sandoz9/2011
95198703Sandoz10/2011
95357903Sandoz12/2011

SOURCE: News release, FDA.

©2010 WebMD, LLC. All Rights Reserved.





STAY INFORMED

Get the Latest health and medical information delivered direct to your inbox!