December 2012 FDA Recall Copaxone by Teva Pharmaceuticals Usa, Inc.
D-249-2013 - Presence of Foreign Substance

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc. on December 5, 2012 for the product Copaxone. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-249-2013

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.
Initiated
12-05-2012
Reported
04-24-2013
Quantity
6,692 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63819
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-05-2013
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot P53847, Exp 01/14

Affected Packages Involved in this Recall

68546-317-00 Copaxone
68546-317-30 Copaxone
68546-325-06 Copaxone
68546-325-12 Copaxone