D-015-2014 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 27, 2013
- Initiation Date
- April 10, 2013
- Termination Date
- November 27, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400 pills
Product Description
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
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.
Distribution Pattern
Nationwide in the US and Canada
Code Information
Lot# 1190001, exp 12/30/2013