FDA recall D-323-2013

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2012-12-22

Report date

2013-05-22

Termination date

2013-08-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Woodbridge, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-323-2013