FDA Recall D-0867-2017
Envy Me · Corp Christi, TX
Class I — life-threatening Terminated 1681 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
LaBri's Body Health Atomic, 60 capsules
Reason for recall
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine.
Recall record
- Recall number
D-0867-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Other
- Distribution
- Product sold nationwide through internet sales. No foreign consignees were reported.
- Recall initiated
- 2017-03-28
- Classified by FDA Center
- 2017-05-25
- FDA published
- 2017-05-31
- Terminated
- 2021-11-03
- Recalling firm
- Envy Me
- Firm location
- Corp Christi, TX