Drug recall D-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
Reason for recall
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.
Lots and codes
Lot P53847, Exp 01/14
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Inc., Sellersville, PA
- Quantity
- 6,692 boxes
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 5, 2012
- Terminated
- July 5, 2013
Related products
- Copaxone – drug information
- NDC 68546-325 Copaxone · Glatiramer Acetate 40 mg/mL · Teva Neuroscience, Inc.
- NDC 68546-317 Copaxone · Glatiramer Acetate 20 mg/mL · Teva Neuroscience, Inc.