FDA Recall D-1050-2014
IQ Formulations, LLC · Sunrise, FL
Class I — life-threatening Terminated 2527 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-1050-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide, Hawaii and Puerto Rico
- Recall initiated
- 2013-11-04
- Classified by FDA Center
- 2014-01-30
- FDA published
- 2014-02-05
- Terminated
- 2020-10-05
- Recalling firm
- IQ Formulations, LLC
- Firm location
- Sunrise, FL