Drug product
Burn 7 Capsules, supplied in 30 capsules bottle
D-1351-2014
Product summary
- Firm
- Deseo Rebajar
- Event
- Event 67162
- Status
- Terminated
- Classification
- Class I
- Quantity
- 120 bottles
- Official record key
drug-enforcement:D-1351-2014
Official wording
Reason: Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement
Code information: MFD: 07.18.2013, EXP: 07.17.2015
Distribution pattern: Puerto Rico only
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement