Status
Terminated
Drug Enforcement D-323-2013
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.
Classification
Class I
Report Date
May 22, 2013
Termination Date
August 12, 2013
Product Information
- 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.
- Product quantity
- 40,480 blister packs
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- D& S Herbals, LLC
- Address
-
1413 Dutchess Ln
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-323-2013
- Event ID
- 64190
- Recall initiation date
- December 22, 2012
- Center classification date
- May 16, 2013
- Code info
- Lot L08108, Exp 06/15
- More code info
- —