Safety Alerts for Human Medical Products > Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials: Recall - Presence of Glass Particulates

Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials: Recall - Presence of Glass Particulates

AUDIENCE: Pharmacy, Risk Manager

ISSUE: Sandoz and FDA notified healthcare professionals of a recall of Methotrexate Injection, 50mg/2mL and 250mg/10mL vials, due to small glass flakes detected in a limited number of vials in four lots. The flakes are the result of delamination of the glass used to manufacture the vials of the two dosage presentations.

Parenteral injection of drug from the affected lots could lead to serious adverse events in areas where the particles lodge. Potential adverse events after intravenous administration include local damage to blood vessels in the lung, localized swelling, and granuloma formation. Intramuscular administration could result in foreign-body inflammatory response, with local pain, swelling and possible long term granuloma formation. Neurologic damage could result from intrathecal administration.

BACKGROUND: Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis.

RECOMMENDATION: 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.

Product lot numbers, label type, expiration dates, and recall instructions are listed in the Press Release.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and
Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


Read the MedWatch safety alert, including a link to the Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm231614.htm

Safety Alerts for Human Medical Products > Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials: Recall - Presence of Glass Particulates