Reported Nov 27, 2013 · Terminated
Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs, Manufactured by Dongseo Biopharm…
Affirm XL, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Affirm XL, Inc. · 27702 Crown Valley Pkway D-4, #195 · Ladera Ranch, CA · 92694
Is this the product you have?
- 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 byAffirm XL, LLC, Ladera Ranch, CA
- Lot codes and dates
Lot# 1190001exp 12/30/2013
- Amount recalled
- 400 pills
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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