D-1050-2014 Class I Terminated

Recalled by IQ Formulations, LLC — Sunrise, FL

Recall Details

Product Type
Drugs
Report Date
February 5, 2014
Initiation Date
November 4, 2013
Termination Date
October 5, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

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

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

Distribution Pattern

Nationwide, Hawaii and Puerto Rico

Code Information

ALL LOTS