FDA recall D-0909-2016

Product

SUPER HERBS 350 mg, 30 capsules per bottle.

Reason for recall

Marketed without an approved NDA/ANDA - presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and/or phenolphthalein.

Distribution

9 consignees - only 9 bottles distributed

Key facts

Status

Terminated

Initiation date

2015-11-23

Report date

2016-06-01

Termination date

2024-10-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0909-2016