FDA Recall D-0991-2015
Ultra ZX Supplements · Miami, FL
Class I — life-threatening Terminated 1143 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein
Recall record
- Recall number
D-0991-2015- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide and Puerto Rico Foreign: Spain and Ecuador
- Recall initiated
- 2015-03-10
- Classified by FDA Center
- 2015-05-05
- FDA published
- 2015-05-13
- Terminated
- 2018-04-26
- Recalling firm
- Ultra ZX Supplements
- Firm location
- Miami, FL