Affirm XL Nutritional Supplement Recalled for Unapproved Sildenafil Analogue
Affirm XL is recalling its nutritional supplement because FDA analysis found it contains sulfoaildenafil, an unapproved analogue of sildenafil.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which meets the rubric criteria for a severity score of 4 (Severe) as it is never below 4 for Class I classifications.
Plain-English summary
Affirm XL, Inc. is recalling Affirm XL Nutritional Supplement, 1 and 10 count blister packs and single pill packs. The product was manufactured by Dongseo Biopharm Corp. in Korea and distributed by Affirm XL, LLC in Ladera Ranch, California. The recall involves Lot# 1190001 with an expiration date of 12/30/2013. The product was distributed nationwide in the US and Canada.
The FDA is recalling this product because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis determined that the product contains sulfoaildenafil, an analogue of sildenafil. Sildenafil is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction. Consequently, the FDA classifies this product as an unapproved new drug.
Consumers who have purchased this product should stop using it and contact the distributor for further instructions. The recall is classified as Class I by the FDA.
The recalled product
- 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
- Manufacturer
- Affirm XL, Inc.
- Category
- Drug — Nutritional Supplement
- Affected units
- 400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# 1190001
- exp 12/30/2013
Distribution
Distributed nationwide across the United States.
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