FDA Recall D-0471-2018
BotanicalNow · Donna, TX
Class I — life-threatening Terminated 1023 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481
Reason for recall
Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
Recall record
- Recall number
D-0471-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S.A. Nationwide
- Recall initiated
- 2017-12-07
- Classified by FDA Center
- 2018-02-20
- FDA published
- 2018-01-31
- Terminated
- 2020-09-25
- Recalling firm
- BotanicalNow
- Firm location
- Donna, TX