D-0631-2022 Class I Terminated
FDA drug recall D-0631-2022 was initiated by Je Dois Lavoir LLC on August 2, 2021 and is designated Class I. 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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns… The recall status is terminated (terminated May 2, 2023). Affected quantity: 783 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 23, 2022
- Initiation Date
- August 2, 2021
- Termination Date
- May 2, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 783 bottles
Product Description
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.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 Pattern
Sold online via website nationwide in the USA and Canada.
Code Information
Lot 102-26, Exp Dec 2022