FDA recall D-0773-2016
Teva Pharmaceuticals USA · Class III · drug
Product
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.
Distribution
Nationwide and Puerto Rico.
Key facts
- Status
- Terminated
- Initiation date
- 2015-11-19
- Report date
- 2016-03-23
- Termination date
- 2016-11-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- North Wales, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0773-2016