April 2012 FDA Recall Cabergoline by Teva Pharmaceuticals Usa, Inc.
D-128-2013 - Impurities/Degradation Products
This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc. on April 24, 2012 for the product Cabergoline. The FDA reported the reason for recall as impurities/degradation products. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-128-2013
Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
04-24-2012
01-23-2013
13,232 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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
12-18-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88
Batch or Lot Expiration Information
Lot# Lot number 6A007046V, exp 07/12
