Recalls / Class III
Class IIID-0773-2016
Product
NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
- Affected lot / code info
- Lot #: 05N533, Exp 11/16
Why it was recalled
Labeling: Not Elsewhere Classified: Lack of leaflets and approved labels on bottles.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 576 bottles
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2015-11-19
- FDA classified
- 2016-03-11
- Posted by FDA
- 2016-03-23
- Terminated
- 2016-11-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0773-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.