Drug product
ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068.
D-0991-2015
Product summary
- Event
- Event 70661
- Status
- Terminated
- Classification
- Class I
- Quantity
- 636 bottles
- Official record key
drug-enforcement:D-0991-2015
Official wording
Reason: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein
Code information: All lots/codes/bottles/packages.
Distribution pattern: Nationwide and Puerto Rico Foreign: Spain and Ecuador
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein