PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: February 5, 2014 Initiated: November 4, 2013 #D-1050-2014

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

Details

Recalling Firm
IQ Formulations, LLC
Distribution
Nationwide, Hawaii and Puerto Rico
Location
Sunrise, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by IQ Formulations, LLC.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Drug on February 5, 2014. Severity: Critical. Recall number: D-1050-2014.