FDA Recall D-0473-2017
Jersey Shore Supplements, LLC · Bradley Beach, NJ
Class I — life-threatening Terminated 1439 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
SLIMFIT X capsules, packaged in a 60-cont bottle
Reason for recall
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibutramine.
Recall record
- Recall number
D-0473-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- New Jersey and Maryland.
- Recall initiated
- 2016-12-09
- Classified by FDA Center
- 2017-02-13
- FDA published
- 2017-02-22
- Terminated
- 2020-11-17
- Recalling firm
- Jersey Shore Supplements, LLC
- Firm location
- Bradley Beach, NJ