drugs Class I Updated 2013-11-27

Affirm XL, Inc. recalls Affirm XL Nutritional Supplement, 1 and 10 count blister pac

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot# 1190001, exp 12/30/2013
View official government recall

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