Methotrexate Injection Recall Issued by Sandoz and Parenta

Sandoz Inc. is recalling 24 lots of methotrexate, an antimetabolite used to treat diseases like psoriasis and rheumatoid arthritis, because vials may be contaminated with flakes of glass. The methotrexate injections were sold under the Sandoz and Parenta brands.

The FDA announced the methotrexate injection recall on October 27, after Sandoz quality control found small glass flakes in four lots of the injections. According to Sandoz, the flakes got into the vials due to the delamination process that occurs while the vials are being manufactured.

Injection of the glass flakes could lead to the flakes traveling through blood vessels to organs, causing serious injury or death. Injection into muscles could cause swelling, pain, and long-term granuloma formation. There have been no incidents or injuries reported in connection with the tainted drugs.

The recall affects 24 lots of Sandoz and Parenta brand Methotrexate Injections in 50mg/2mL and 250mg/10mL vials. The vials were distributed in 10 packs and individual vials. The 50mg/2mL vials have lot numbers of 92395606, 92760803, 92965104, 92965106, 92965904, 93255704, 93502204, 93635404, 93681704, 93794904, 95198604, 95357804, 95537704 and 95987004. The vials have expiration dates ranging from 12/2010 to 3/2012. The 250mg/10mL vials have lot numbers of 92395703, 92760903, 92965203, 92966003, 93255803, 93502303, 93635503, 93795003, 95198703 and 95357903. The vials have expiration dates ranging from 12/2010 to 12/2011.

This is at least the third drug recall this year due to glass flake contamination of drug vials. In May, Baxter International, Inc. recalled about 3,200 vials of Hylenex, a pediatric rehydration medication due to glass flakes. In September, about 200 lots of Epogen and Procrit, Amgen’s anemia drugs, were also recalled due to glass flakes. There were no reports of incidents or injuries in either recall.

Sandoz has informed distributors, wholesalers and pharmacies of the recall. The FDA and Sandoz recommend that healthcare professionals and patients immediately discontinue use of this product. Patients should contact their healthcare providers if they experience problems that might be related to contaminated methotrexate injections and should report any adverse events to FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/medwatch/report.htm.