D-1050-2014 Class I Terminated
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