FDA recall D-1222-2014

Product

Dream Body Slimming Capsule (Chinese bitter orange 24%, Cassia Seed 18%, Aloe 16%, Lotus Leaf Extract 12%, Medical Amylum 30%), 350 mg, 30-count bottles, Made in China (Beijing).

Reason for recall

Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-12-10

Report date

2014-04-16

Termination date

2017-03-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kearney, NE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1222-2014