April 2013 FDA Recall Drug by Affirm Xl, Inc.
D-015-2014 - Marketed Without An Approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Affirm Xl, Inc. on April 10, 2013 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-015-2014

Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.
Initiated
04-10-2013
Reported
11-27-2013
Quantity
400 pills

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64878
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.
Affirm XL, 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.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-27-2013
Product Description About Product Description
Full technical description of the product.
Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs, Manufactured by Dongseo Biopharm Corp., Yongin City, Kyonggi do, Korea, distributed by: Affirm XL, LLC, Ladera Ranch, CA

Batch or Lot Expiration Information

Lot# 1190001, exp 12/30/2013