FDA recall D-015-2014

Affirm XL, Inc. · Class I · 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

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

Nationwide in the US and Canada

Key facts

Status: Terminated
Initiation date: 2013-04-10
Report date: 2013-11-27
Termination date: 2013-11-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Ladera Ranch, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-015-2014