August 2014 FDA Recall Drug by Chironutraceutical Llc
D-1569-2014 - Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.

This Class III drug recall was voluntarily initiated by Chironutraceutical Llc on August 20, 2014 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; product contains unapproved hhcg.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1569-2014

Reason for Recall
Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.
Initiated
08-20-2014
Reported
09-17-2014
Quantity
12,948 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69076
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
ChiroNutraceutical LLC
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.
U.S. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-16-2015
Product Description About Product Description
Full technical description of the product.
CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005.

Batch or Lot Expiration Information

Lot# : 072010-22, Exp: 12/2013
Lot# : 072010-23, Exp: 01/2014
Lot# : 072010-25, Exp: 03/2014
Lot# : 072010-26, Exp: 04/2014
Lot# : 072010-27, Exp: 05/2014
Lot# : 072010-29, Exp: 07/2014
Lot# : 072010-30, Exp: 08/2014
Lot# : 072010-31, Exp: 09/2014
Lot# : 072010-33, Exp: 11/2014
Lot# : 072010-34, Exp: 01/2015
Lot# : 072010-36, Exp: 02/2015
Lot# : 072010-39, Exp: 05/2015
Lot# : 072010-43, Exp: 06/2015; and
Lot# : 072010-48, Exp: 10/2015.