Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga ...
FDA Recall #D-265-2013 — Class I — December 19, 2011
Product Description
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
Recalling Firm
Body Basics Inc — Canoga Park, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
30,000 capsules
Distribution
Nationwide
Code Information
Lot number 008A, expiration date Dec 2014, UPC code 830733002016
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated