Drug product
NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
D-0773-2016
Product summary
- Event
- Event 72999
- Status
- Terminated
- Classification
- Class III
- Quantity
- 576 bottles
- Official record key
drug-enforcement:D-0773-2016
Official wording
Reason: Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Code information: Lot #: 05N533, Exp 11/16
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Unknown
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.