Status
Terminated
Drug Enforcement D-001-2014
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
Classification
Class II
Report Date
November 27, 2013
Termination Date
August 27, 2014
Product Information
- Product description
- 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.
- Product quantity
- 6,803 cartons
- Reason for recall
- Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Teva Pharmaceuticals USA
- Address
-
425 Privet Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-001-2014
- Event ID
- 66672
- Recall initiation date
- October 24, 2013
- Center classification date
- November 20, 2013
- Code info
- Lot X06381, Exp 10/14
- More code info
- —