365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
Reported: February 23, 2022 Initiated: August 2, 2021 #D-0631-2022
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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.
Details
- Recalling Firm
- Je Dois Lavoir LLC
- Units Affected
- 783 bottles
- Distribution
- Sold online via website nationwide in the USA and Canada.
- Location
- Visalia, CA
Frequently Asked Questions
What product was recalled? ▼
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL. Recalled by Je Dois Lavoir LLC. Units affected: 783 bottles.
Why was this product 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NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 23, 2022. Severity: Critical. Recall number: D-0631-2022.
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