FDA recall D-265-2013

Product

Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA

Reason for recall

Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2011-12-19

Report date

2013-04-24

Termination date

2013-06-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Canoga Park, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-265-2013