Drug product
Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30
D-1442-2012
Product summary
- Event
- Event 62241
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,647 cartons
- Official record key
drug-enforcement:D-1442-2012
Official wording
Reason: Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Code information: Lot number X05011, Exp 08/13
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance