D-0991-2015 Class I Terminated
FDA drug recall D-0991-2015 was initiated by Ultra ZX Supplements on March 10, 2015 and is designated Class I. Reason for recall: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein The recall status is terminated (terminated April 26, 2018). Affected quantity: 636 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 13, 2015
- Initiation Date
- March 10, 2015
- Termination Date
- April 26, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 636 bottles
Product Description
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.
Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein
Distribution Pattern
Nationwide and Puerto Rico Foreign: Spain and Ecuador
Code Information
All lots/codes/bottles/packages.