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Class I: serious health riskTerminated

Je Dois Lavoir 365 SKINNY High Intensity Capsules Recall

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

Je Dois Lavoir LLC · Visalia, CA

Risk level
Class I
Reported by FDA
Feb 23, 2022
Recall ID
D-0631-2022
Check your lot numberHow we source this data

Summary

Je Dois Lavoir recalled 365 SKINNY High Intensity Capsules starting Aug 2, 2021. The FDA classified it as Class I (serious health risk) and published enforcement report D-0631-2022 on Feb 23, 2022. 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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns. Status: Terminated.

Why it was recalled

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FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.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

Lot numbers, UPCs & expiration codes

Lot 102-26, Exp Dec 2022

Where it was sold

Sold online via website nationwide in the USA and Canada.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0631-2022
Classification
Class I
Status
Terminated
Recall initiated
Aug 2, 2021
FDA report date
Feb 23, 2022
Quantity
783 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Je Dois Lavoir LLC

Original FDA data

Every field from FDA enforcement report D-0631-2022, exactly as published.

Show all FDA fields
City
Visalia
State
CA
Status
Terminated
Country
United States
Event ID
88409
Address
3936 E Evergreen Ave
Code information
Lot 102-26, Exp Dec 2022
Postal code
93292-1281
Report date
Feb 23, 2022
Product type
Drugs
Recall number
D-0631-2022
Classification
Class I
Recalling firm
Je Dois Lavoir LLC
Product quantity
783 bottles
Termination date
May 2, 2023
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.
Voluntary / mandated
Voluntary: Firm initiated
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.
Recall initiation date
Aug 2, 2021
Initial firm notification
Press Release
Center classification date
Feb 23, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0631-2022, published Feb 23, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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