Why it was recalled
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
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
Lot numbers, UPCs & expiration codes
ALL LOTS
Where it was sold
Nationwide, Hawaii and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1050-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 4, 2013
- FDA report date
- Feb 5, 2014
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- IQ Formulations, LLC
Original FDA data
Every field from FDA enforcement report D-1050-2014, exactly as published.
Show all FDA fields
- City
- Sunrise
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 66965
- Address
- 523 Sawgrass Corporate Pkwy
- Code information
- ALL LOTS
- Postal code
- 33325-6259
- Report date
- Feb 5, 2014
- Product type
- Drugs
- Recall number
- D-1050-2014
- Classification
- Class I
- Recalling firm
- IQ Formulations, LLC
- Termination date
- Oct 5, 2020
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide, Hawaii and Puerto Rico
- Recall initiation date
- Nov 4, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jan 30, 2014