Status
Terminated
Drug Enforcement D-015-2014
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.
Classification
Class I
Report Date
November 27, 2013
Termination Date
November 27, 2013
Product Information
- 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
- Product quantity
- 400 pills
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide in the US and Canada
Location & Firm
- Recalling firm
- Affirm XL, Inc.
- Address
-
27702 Crown Valley Pkway D-4, #195
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-015-2014
- Event ID
- 64878
- Recall initiation date
- April 10, 2013
- Center classification date
- November 20, 2013
- Code info
- Lot# 1190001, exp 12/30/2013
- More code info
- —