FDA recall D-0677-2017

Product

hCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Colloidal Silver B12, Stabilizers/Excipients, Not For Medical Use, Must Be Refrigerated, Distributed by HCG Body Shaper, St. Peters, MO

Reason for recall

Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-03-28

Report date

2017-05-03

Termination date

2019-05-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Peters, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0677-2017