FDA recall D-0631-2022

Product

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FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.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

Sold online via website nationwide in the USA and Canada.

Key facts

Status

Terminated

Initiation date

2021-08-02

Report date

2022-02-23

Termination date

2023-05-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Visalia, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0631-2022