Recalls / Class II
Class IID-001-2014
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.
- Brand name
- Copaxone
- Generic name
- Glatiramer Acetate
- Active ingredient
- Glatiramer Acetate
- Route
- Subcutaneous
- NDCs
- 68546-317, 68546-325
- FDA application
- NDA020622
- Affected lot / code info
- Lot X06381, Exp 10/14
Why it was recalled
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Neuroscience, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 6,803 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-10-24
- FDA classified
- 2013-11-20
- Posted by FDA
- 2013-11-27
- Terminated
- 2014-08-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-001-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.