FDA Recall D-1322-2014
Pain Free By Nature · Harper, KS
Class I — life-threatening Terminated 445 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.
Reason for recall
Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.
Recall record
- Recall number
D-1322-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide including Puerto Rico
- Recall initiated
- 2014-03-13
- Classified by FDA Center
- 2014-05-15
- FDA published
- 2014-05-21
- Terminated
- 2015-06-01
- Recalling firm
- Pain Free By Nature
- Firm location
- Harper, KS