FDAFDA · Food and drugs·Recall number D-001-2014
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.
Published November 27, 2013 · Recall initiated: October 24, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- COPAXONE
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide
- UPC
- 368546317304
- Lot
- Lot X06381, Exp 10/14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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