Reported Apr 24, 2013 · Terminated
Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps…
Teva Pharmaceuticals USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA, Inc. · 650 Cathill Rd · Sellersville, PA · 18960-1512
Is this the product you have?
- Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringes and 33 Alcohol Preps (swabs) per box
- Marketed byTEVA Neuroscience, Inc., Kansas City, MO 64131
- Distributed byTEVA Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 68546-317-30
- Lot codes and dates
Lot P53847Exp 01/14
- Amount recalled
- 6,692 boxes
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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