Drug 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
D-1050-2014
Product summary
- Event
- Event 66965
- Status
- Terminated
- Classification
- Class I
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-1050-2014
Official wording
Reason: 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
Code information: ALL LOTS
Distribution pattern: Nationwide, Hawaii and Puerto Rico
Derived failure modes
-
Unknown
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