Copaxone (glatiramer acetate injection), 20 mg/1 mL, packaged in 30 single use PRE-FILLED syringe...
FDA Recall #D-249-2013 — Class II — December 5, 2012
Product Description
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.
Recalling Firm
Teva Pharmaceuticals USA, Inc. — Sellersville, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
6,692 boxes
Distribution
Nationwide
Code Information
Lot P53847, Exp 01/14
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated