D-1235-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 23, 2014
- Initiation Date
- September 27, 2013
- Termination Date
- January 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 172,800 capsules
Product Description
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 Pattern
Nationwide and internationally via internet sales.
Code Information
All lot codes and expiration dates.