Drug product
Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe, packaged in 30 single-use PRE-FILLED Syringes and 33 Alcohol Preps (Swabs) per carton, Rx only, Marketed by: Teva Neuroscience, Inc., Kansas City, MO 64131; Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30, UPC 3 68546 31730 4.
D-001-2014
Product summary
- Event
- Event 66672
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,803 cartons
- Official record key
drug-enforcement:D-001-2014
Official wording
Reason: Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
Code information: Lot X06381, Exp 10/14
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter