May 2012 FDA Recall Copaxone by Teva Pharmaceuticals Usa, Inc.
D-1442-2012 - Presence of Foreign Substance
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc. on May 18, 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-1442-2012
Presence of Foreign Substance: Recall is being initiated due to the presence of a foreign particle identified from a customer complaint.
05-18-2012
08-15-2012
6,647 cartons
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
04-11-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Copaxone (glatiramer acetate injection), 20mg/mL, 1 mL , Rx only, Marketed by: Teva Neuroscience - NDC 68546-317-30
Batch or Lot Expiration Information
Lot# Lot number X05011, Exp 08/13
