Je Dois Lavoir LLC: Drug Recall

Recall #D-0631-2022 · 08/02/2021

Class I: Dangerous

Recall Details

Recall Number
D-0631-2022
Classification
Class I
Product Type
Drug
Recalling Firm
Je Dois Lavoir LLC
Status
Terminated
Date Initiated
08/02/2021
Location
Visalia, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
783 bottles

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FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.

Product Description

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

Distribution Pattern

Sold online via website nationwide in the USA and Canada.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.