FDA recall D-0628-2021

Product

Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies, Manufactured for: Imperia-Elita Ltd. & Co, KG D- 35435 Wettenberg

Reason for recall

Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine

Distribution

Nationwide within the United States

Key facts

Status

Ongoing

Initiation date

2021-05-11

Report date

2021-06-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Glendale, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0628-2021