365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
Summary
The FDA issued a Class I for 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTER by Je Dois Lavoir LLC. Reason: Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was w.
Details
Source
Drug Recall
External ID
D-0631-2022
Action Date
2022-02-23
Status
Terminated
Category
drug
Product Description
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
Lot/Code Info: Lot 102-26, Exp Dec 2022
Quantity Affected: 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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.
Distribution
Sold online via website nationwide in the USA and Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-02
Company
Visalia, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Je Dois Lavoir LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Je Dois Lavoir LLC have FDA actions?
This is the only FDA action we have on record for Je Dois Lavoir LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0631-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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