FDA-Drug2022-02-23Class I

365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL

Je Dois Lavoir LLC
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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.

Sold states
Sold online via website nationwide in the USA and Canada.
Affected count
783 bottles
Manufactured in
3936 E Evergreen Ave, N/A, Visalia, CA, United States
Products
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0631-2022

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