FDA recall D-1235-2014

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.

Reason for recall

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.

Distribution

Nationwide and internationally via internet sales.

Key facts

Status

Terminated

Initiation date

2013-09-27

Report date

2014-04-23

Termination date

2015-01-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Williamstown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1235-2014