November 2013 FDA Recall Drug by Iq Formulations, Llc
D-1050-2014 - Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug

This Class I drug recall was voluntarily initiated by Iq Formulations, Llc on November 4, 2013 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; this product is being recalled for containing an undeclared diuretic called triamterene, an fda approved prescription only medication used to treat edema, making it an unapproved new drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1050-2014

Reason for Recall
Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug
Initiated
11-04-2013
Reported
02-05-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
66965
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
IQ Formulations, 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide, Hawaii and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-05-2020
Product Description About Product Description
Full technical description of the product.
Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement, Manufactured and Distributed by Metabolic Nutrition, Sunrise, Florida, www.metabolicnutrition.com

Batch or Lot Expiration Information

Lot# ALL LOTS