Sandoz is conducting a voluntary, nationwide recall of two lots of its methotrexate sodium, USP, 25 mg/mL, 40 mL vial injectable drug because it discovered particulate matter in some vials, the FDA announced today.
“Parenteral injection … from affected lots can lead to microembolization in areas where the particles lodge,” a press release stated. Sandoz discovered the issue during a routine quality examination of retention samples. Sandoz is unaware of any related adverse events, and clinical symptoms were not expected from the microemboli, according to the manufacturer.
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