FDA Recall D-015-2014
Affirm XL, Inc. · Ladera Ranch, CA
Class I — life-threatening Terminated 231 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
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 record
- Recall number
D-015-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the US and Canada
- Recall initiated
- 2013-04-10
- Classified by FDA Center
- 2013-11-20
- FDA published
- 2013-11-27
- Terminated
- 2013-11-27
- Recalling firm
- Affirm XL, Inc.
- Firm location
- Ladera Ranch, CA