October 2013 FDA Recall Copaxone by Teva Pharmaceuticals Usa
D-001-2014 - Presence of Particulate Matter

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on October 24, 2013 for the product Copaxone. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-001-2014

Reason for Recall
Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported through a consumer complaint about a pre-filled syringe.
Initiated
10-24-2013
Reported
11-27-2013
Quantity
6,803 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66672
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
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.
08-27-2014
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration Information

Lot# Lot X06381, Exp 10/14

Affected Packages Involved in this Recall

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