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.
D-1235-2014
Product summary
- Event
- Event 66406
- Status
- Terminated
- Classification
- Class I
- Quantity
- 172,800 capsules
- Official record key
drug-enforcement:D-1235-2014
Official wording
Reason: 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.
Code information: All lot codes and expiration dates.
Distribution pattern: Nationwide and internationally via internet sales.
Derived failure modes
-
Unknown
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.