FDA recall D-1146-2016

Product

SlimeX-15 Capsules, 15 mg, 30-count bottles, Marketed by: Signature Pharmaceuticals Ltd. MUMBAI-400-030 Manufactured in India by: HAB Pharmaceuticals & Research Limited 10-Pharma City, SIDCUL, Selaqui, Dehradun, 248 197

Reason for recall

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-12-15

Report date

2016-07-13

Termination date

2020-04-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jewett, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1146-2016