Haute Health, LLC recalls Prolifta Dietary Supplement Prolifta, 400mg/capsule, Packaged in 1 and 2 capsule blister packs and 4, 12, and 24 capsule
Recalled April 23, 2014 · FDA recall D-1235-2014 · Haute Health
Hazard
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug. · FDA Class I
Units
172,800 capsules
Sold at
Nationwide and internationally via internet sales.
Description
Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
Product
Prolifta Dietary Supplement Prolifta, 400mg/capsule, Packaged in 1 and 2 capsule blister packs and 4, 12, and 24 capsule bottles Made in the USA Distributed by: Prolifta LLC 1+877.239.8231 www.proliftaherbal.com.
Manufacturer(s)
Haute Health, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →