FDAFDA · Food and drugs·Recall number D-0631-2022
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
Published February 23, 2022 · Recall initiated: August 2, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Je Dois Lavoir LLC
- Distributor
- Sold online via website nationwide in the USA and Canada.
- Lot
- Lot 102-26, Exp Dec 2022
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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