November 1, 2010 – last week, Sandoz Inc. announced that it will be recalling all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product (“methotrexate”) to the consumer/user level.
The company decided on the recall of all 24 lots of the affected product following the finding of small glass flakes by Sandoz quality control 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 these two dosage presentations.
Sadly, there is the potential to develop adverse reactions in areas where these glass particles lodge. In fact, parenteral 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 administration. 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.
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. Additionally, as noted in the product’s labeling, parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.