Drug product
Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Distributed by: Freedom Trading, NJ 08863, UPC 7 18122 90678 9.
D-323-2013
Product summary
- Event
- Event 64190
- Status
- Terminated
- Classification
- Class I
- Quantity
- 40,480 blister packs
- Official record key
drug-enforcement:D-323-2013
Official wording
Reason: Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved drug for the treatment of male erectile dysfunction making this an unapproved new drug.
Code information: Lot L08108, Exp 06/15
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved drug for the treatment of male erectile dysfunction making this an unapproved new drug.