Drug 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
D-015-2014
Product summary
- Firm
- Affirm XL, Inc.
- Event
- Event 64878
- Status
- Terminated
- Classification
- Class I
- Quantity
- 400 pills
- Official record key
drug-enforcement:D-015-2014
Official wording
Reason: 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.
Code information: Lot# 1190001, exp 12/30/2013
Distribution pattern: Nationwide in the US and Canada
Derived failure modes
-
Unknown
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.