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
FDA recall notice · announced February 5, 2014 · Iq Formulations
Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.
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
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
Notes
Distribution: Nationwide, Hawaii and Puerto Rico
Lot/code information: ALL LOTS
Status: Terminated
Products in this recall event:
- Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement, Manufactured and Distributed by Metabolic Nutrition, Sunrise, Florida, www.metabo (D-1050-2014)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.