November 2015 FDA Recall Drug by Teva Pharmaceuticals Usa
D-0773-2016 - Labeling

This Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on November 19, 2015 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0773-2016

Reason for Recall
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Initiated
11-19-2015
Reported
03-23-2016
Quantity
576 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72999
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
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 and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-15-2016
Product Description About Product Description
Full technical description of the product.
NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL

Batch or Lot Expiration Information

Lot# : 05N533, Exp 11/16