FDA Recall D-323-2013
D& S Herbals, LLC · Woodbridge, NJ
Class I — life-threatening Terminated 233 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
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 record
- Recall number
D-323-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2012-12-22
- Classified by FDA Center
- 2013-05-16
- FDA published
- 2013-05-22
- Terminated
- 2013-08-12
- Recalling firm
- D& S Herbals, LLC
- Firm location
- Woodbridge, NJ