Drug 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
D-0677-2017
Product summary
- Firm
- Gary Wood
- Event
- Event 76680
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1305-1400 bottles
- Official record key
drug-enforcement:D-0677-2017
Official wording
Reason: Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug
Code information: No code information printed on bottle
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug