Class II
Terminated
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
- Company
- Teva Pharmaceuticals Usa, Inc.
- Recall Initiated
- December 5, 2012
- Posted
- April 24, 2013
- Recall Number
- D-249-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6,692 boxes
- Firm Location
- Sellersville, PA, United States
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.
Distribution
Nationwide
Lot / Code Info
Lot P53847, Exp 01/14
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