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

December 22, 2012

Class I

Product summary

Firm: D& S Herbals, LLC
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
reason.no_named_rule · v1.0.0

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.