NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, ...
FDA Recall #D-0773-2016 — Class III — November 19, 2015
Product Description
NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
Reason for Recall
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Recalling Firm
Teva Pharmaceuticals USA — North Wales, PA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
576 bottles
Distribution
Nationwide and Puerto Rico.
Code Information
Lot #: 05N533, Exp 11/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated