D-323-2013 Class I Terminated
FDA drug recall D-323-2013 was initiated by D& S Herbals, LLC on December 22, 2012 and is designated Class I. 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 d… The recall status is terminated (terminated August 12, 2013). Affected quantity: 40,480 blister packs.
Recall Details
- Product Type
- Drugs
- Report Date
- May 22, 2013
- Initiation Date
- December 22, 2012
- Termination Date
- August 12, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40,480 blister packs
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.
Distribution Pattern
Nationwide
Code Information
Lot L08108, Exp 06/15