FDA recall D-0593-2018

Bella All Natural · Class I · drug

Product

Bella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015

Reason for recall

Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.

Distribution

Product was distributed in California to online customers and retail stores.

Key facts

Status
Terminated
Initiation date
2018-02-14
Report date
2018-03-14
Termination date
2019-01-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Los Angeles, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0593-2018