Why it was recalled
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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot# 1190001, exp 12/30/2013
Where it was sold
Nationwide in the US and Canada
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-015-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 10, 2013
- FDA report date
- Nov 27, 2013
- Quantity
- 400 pills
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Affirm XL, Inc.
Original FDA data
Every field from FDA enforcement report D-015-2014, exactly as published.
Show all FDA fields
- City
- Ladera Ranch
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 64878
- Address
- 27702 Crown Valley Pkway D-4, #195
- Code information
- Lot# 1190001, exp 12/30/2013
- Postal code
- 92694
- Report date
- Nov 27, 2013
- Product type
- Drugs
- Recall number
- D-015-2014
- Classification
- Class I
- Recalling firm
- Affirm XL, Inc.
- Product quantity
- 400 pills
- Termination date
- Nov 27, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the US and Canada
- Recall initiation date
- Apr 10, 2013
- Initial firm notification
- Press Release
- Center classification date
- Nov 20, 2013