On October 24, 2013, Teva Pharmaceuticals USA initiated a recall of Copaxone, the brand name for glatiramer acetate injection. The recall was classified as Class II by the FDA. The action followed a consumer complaint reporting a foreign particle found in a pre-filled syringe. The affected product was Copaxone 20 mg per 1 mL, supplied as 1 mL pre-filled syringes packaged in cartons of 30 single-use syringes with 33 alcohol preps, NDC 68546-317-30. The product was marketed by Teva Neuroscience, Inc. and distributed by Teva Pharmaceuticals USA, Inc. According to FDA records, the recall status is listed as terminated. The classification and reason are reported here as stated in the FDA recall record, without further characterization of risk. This brief reflects only the details provided in that record, including the reason for the recall, the firm involved, and the initiation date. No additional outcomes or findings beyond these facts are included. Readers seeking general background on glatiramer, including its approved use and regulatory status, can consult the compound overview for further context.
Copaxone Recalled in 2013 Over Particulate Matter (Class II)
Drafted by an automated content engine from FDA, PubChem, ClinicalTrials.gov, NIH DSLD, and Open Beauty Facts data.
See the full glatiramer overview
Source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts