D-0677-2017 Class II Terminated
FDA drug recall D-0677-2017 was initiated by Gary Wood on March 28, 2017 and is designated Class II. 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 The recall status is terminated (terminated May 8, 2019). Affected quantity: 1305-1400 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 3, 2017
- Initiation Date
- March 28, 2017
- Termination Date
- May 8, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1305-1400 bottles
Product Description
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 Pattern
Nationwide
Code Information
No code information printed on bottle