Drug product
Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA
D-0246-2019
Product summary
- Firm
- Zero Xtreme USA
- Event
- Event 81436
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 bottles
- Official record key
drug-enforcement:D-0246-2019
Official wording
Reason: Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine
Code information: Lot: 1220062085 Exp. 03/2020
Distribution pattern: Nationwide within the USA.
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine