Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30

FDA recall notice · announced August 15, 2012 · Teva Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30

Reason for recall

Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.

Notes

Distribution: Nationwide
Lot/code information: Lot number X05011, Exp 08/13
Quantity: 6,647 cartons
Status: Terminated
Products in this recall event:
- Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30 (D-1442-2012)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.