drugs Class II Updated 2013-04-24

Teva Pharmaceuticals USA, Inc. recalls Copaxone (glatiramer acetate injection), 20 mg/1 mL, package

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot P53847, Exp 01/14
View official government recall

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