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news.Sandoz has started a voluntary recall of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate injection, USP product (methotrexate) to the consumer/user level in the US.
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Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis.
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.
Sandoz said that the flakes are the result of delamination of the glass used to manufacture the vials of these two dosage presentations and that the particle size has the potential to develop adverse reactions in areas where the particles lodge.
Sandoz informed that it has not received any adverse event reports to date or product complaints attributable to particles from any lot of methotrexate, including the lots where flakes have been found.