Recalls / Class II
Class IID-1442-2012
Product
Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - 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 number X05011, Exp 08/13
Why it was recalled
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Manufacturer
- Teva Neuroscience, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 6,647 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-05-18
- FDA classified
- 2012-08-03
- Posted by FDA
- 2012-08-15
- Terminated
- 2013-04-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1442-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.