March 2017 FDA Recall Drug by Gary Wood
D-0677-2017 - Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug

This Class II drug recall was voluntarily initiated by Gary Wood on March 28, 2017 for the product Drug. The FDA reported the reason for recall as 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 product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0677-2017

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
Initiated
03-28-2017
Reported
05-03-2017
Quantity
1305-1400 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76680
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gary Wood
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-08-2019
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# No code information printed on bottle