FDA Recall D-0121-2018
EZWeightLossTX LLC · Corpus Christi, TX
Class I — life-threatening Terminated 1297 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 Exclusively distributed worldwide by LaBri's Body Health.
Reason for recall
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplements: products found to be tainted with sibutramine making these unapproved drugs.
Recall record
- Recall number
D-0121-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2017-07-24
- Classified by FDA Center
- 2017-12-20
- FDA published
- 2017-12-27
- Terminated
- 2021-02-10
- Recalling firm
- EZWeightLossTX LLC
- Firm location
- Corpus Christi, TX