FDA recall D-0471-2018

BotanicalNow · Class I · drug

Product

BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481

Reason for recall

Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.

Distribution

U.S.A. Nationwide

Key facts

Status
Terminated
Initiation date
2017-12-07
Report date
2018-01-31
Termination date
2020-09-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Donna, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0471-2018