FDA-Drug2013-11-27Class I
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
Affirm XL, Inc.
Hazard
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.
Sold states
Nationwide in the US and Canada
Affected count
400 pills
Manufactured in
27702 Crown Valley Pkway D-4, #195, Ladera Ranch, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-015-2014Don't want to check this manually?
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