Sandoz Inc.has initiated a voluntary recall in the US of all
50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate
Injection, USP product ("methotrexate") to the consumer/user level.
Consistent with its commitment to quality and patient safety, Sandoz is initiating
this voluntary 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.
Due to particle size, there is the potential to develop
adverse reactions in areas where the particles lodge. While it is unlikely, 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.
Intra-arterial administration could result in damage to
blood vessels in the distal extremities or organs. To date, Sandoz has not
received any adverse event reports or product complaints attributable to particles
from any lot of methotrexate, including the lots where flakes have been found.
Methotrexate is an antimetabolite used in the treatment of
neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular
juvenile rheumatoid arthritis. The affected products are only the 50mg/2mL and
250mg/10mL presentations of methotrexate.