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Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle...

FDA Recall #D-1050-2014 — Class I — November 4, 2013

Recall #D-1050-2014 Date: November 4, 2013 Classification: Class I Status: Terminated

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

Recalling Firm

IQ Formulations, LLC — Sunrise, FL

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Distribution

Nationwide, Hawaii and Puerto Rico

Code Information

ALL LOTS

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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