Drug product
Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180
D-1165-2016
Product summary
- Event
- Event 72227
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 70,350 capsules
- Official record key
drug-enforcement:D-1165-2016
Official wording
Reason: Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.
Code information: Lot 1220062085, Exp. 09/16
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.