Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials Recalled due to Detected Glass Particulates

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Risk Managers and Pharmacy healthcare personnel are informed by the FDA that methotrexate Injection, 50mg/2mL and 250mg/10mL Vials are recalled because there is a potential of small glass flakes presence in the vials. This can lead to serious adverse events.

Background of Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials

Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials, by Sandoz Inc., are used to treat severe psoriasis, neoplastic diseases, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis.

FDA Alert on Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials

FDA’s reason for the recall is that small glass flakes have been detected in a small number of vials in specific lots. Injection from the affected lots can lead to serious adverse events including granuloma formation, swelling, local damage to blood vessels in the lung and neurological damage.

Recommendation on Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials

“Customers and patients should immediately discontinue use of this product and patients should contact their physician or healthcare provider if they experience any problem that might be related to the use of this product. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.”

Contacting the FDA to report cases with Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials

In case of detection of adverse events or side effects related to the use of Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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