FDA recall D-1050-2014

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

Distribution

Nationwide, Hawaii and Puerto Rico

Key facts

Status

Terminated

Initiation date

2013-11-04

Report date

2014-02-05

Termination date

2020-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sunrise, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1050-2014