Teva Pharmaceuticals USA, Inc. initiated a Class II recall of Copaxone (glatiramer acetate injection) on December 5, 2012. The recall involved the 20 mg/1 mL formulation packaged in 30 single use pre-filled syringes with 33 alcohol prep swabs per box, NDC 68546-317-30. The product was marketed by Teva Neuroscience, Inc. of Kansas City, MO, and distributed by Teva Pharmaceuticals USA, Inc. of North Wales, PA.
The stated reason for the recall was an elevated number of patient complaints reporting a visible presence of medical grade silicone oil. This silicone oil is described as essential to the functionality of the syringe and plunger stopper system. FDA assigned this action a Class II classification, with the recall identification number D-249-2013.
According to the available record, the recall status is listed as Terminated. No additional details about patient outcomes or further corrective actions were provided in this record.
This brief reports only the facts contained in the recall record: the classification, the stated reason, the recalling firm, the initiation date, and the current status. Readers can consult the compound overview for further context on glatiramer.</body_markdown>
<parameter name="sources">["https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts"]