FDA Recall D-0631-2022
Je Dois Lavoir LLC · Visalia, CA
Class I — life-threatening Terminated 638 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
Reason for recall
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.
Recall record
- Recall number
D-0631-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Sold online via website nationwide in the USA and Canada.
- Recall initiated
- 2021-08-02
- Classified by FDA Center
- 2022-02-23
- FDA published
- 2022-02-23
- Terminated
- 2023-05-02
- Recalling firm
- Je Dois Lavoir LLC
- Firm location
- Visalia, CA