On May 18, 2012, Teva Pharmaceuticals USA, Inc. initiated a recall of Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL, NDC 68546-317-30, marketed by Teva Neuroscience. The recall was classified as Class II by the FDA. The stated reason for the recall was the presence of a foreign substance, identified from a customer complaint regarding a foreign particle in the product. Copaxone is an Rx only product. The recall action is listed with a status of terminated. This record reflects a Class II recall classification and the reason for initiation as documented by the recalling firm. No additional details beyond the classification, reason, firm, and initiation date were provided in this record. Readers seeking more context on glatiramer acetate, including its approved uses and regulatory history, can consult the compound overview for further background.
Copaxone (Glatiramer Acetate) Class II Recall Initiated May 2012
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Source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts