Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Di...
FDA Recall #D-323-2013 — Class I — December 22, 2012
Product Description
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.
Reason for Recall
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.
Recalling Firm
D& S Herbals, LLC — Woodbridge, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
40,480 blister packs
Distribution
Nationwide
Code Information
Lot L08108, Exp 06/15
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated