Class I
Terminated
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
This recall has been terminated (originally issued November 27, 2013).
- Company
- Affirm Xl, Inc.
- Recall Initiated
- April 10, 2013
- Posted
- November 27, 2013
- Recall Number
- D-015-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 400 pills
- Firm Location
- Ladera Ranch, CA, United States
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot# 1190001, exp 12/30/2013
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