Recalls / Class II
Class IID-249-2013
Product
Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box, Marketed by: TEVA Neuroscience, Inc., Kansas City, MO 64131; Distributed by: TEVA Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30
- 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 P53847, Exp 01/14
Why it was recalled
Presence of Foreign Substance: Product is being recalled due to receiving an elevated number of patient complaints related to a visible presence of medical grade silicone oil essential to the functionality of the syringe and plunger stopper system.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Manufacturer
- Teva Neuroscience, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, N/A, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 6,692 boxes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-12-05
- FDA classified
- 2013-04-12
- Posted by FDA
- 2013-04-24
- Terminated
- 2013-07-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-249-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.