FDAFDA · Food and drugs·Recall number D-015-2014
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
Published November 27, 2013 · Recall initiated: April 10, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Affirm XL, Inc.
- Distributor
- Nationwide in the US and Canada
- Lot
- Lot# 1190001, exp 12/30/2013
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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