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Recall Observatory FDA recall evidence

Drug product

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

D-0631-2022

August 02, 2021

Class I

Product summary

Firm
Je Dois Lavoir LLC
Event
Event 88409
Status
Terminated
Classification
Class I
Quantity
783 bottles
Official record key
drug-enforcement:D-0631-2022

Official wording

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FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.

Code information: Lot 102-26, Exp Dec 2022

Distribution pattern: Sold online via website nationwide in the USA and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.