December 2011 FDA Recall Drug by Body Basics Inc
D-265-2013 - Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction

This Class I drug recall was voluntarily initiated by Body Basics Inc on December 19, 2011 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda; product contains sildenafil, an active ingredient in a fda approved product for the treatment of erectile dysfunction. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-265-2013

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
Initiated
12-19-2011
Reported
04-24-2013
Quantity
30,000 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62836
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Body Basics Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-05-2013
Product Description About Product Description
Full technical description of the product.
Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA

Batch or Lot Expiration Information

Lot# Lot number 008A, expiration date Dec 2014, UPC code 830733002016