Affirm XL: Recall - Undeclared Drug Ingredient
ISSUE: Affirm XL, Inc. is conducting a voluntary recall to the consumer level after FDA lab analysis testing found the product to contain an analogue of sildenafil. Sildenafil is an active ingredient used in an FDA-approved product for the treatment of male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for this product.
Use of this product may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
BACKGROUND: Affirm XL Tablet is marketed as a dietary supplement for sexual enhancement. It is sold nationwide in 10 count blister packs and single pill packs.
There are no illnesses associated with this product.
RECOMMENDATION: Affirm XL, Inc advises any customers in possession of the Affirm XL product matching the lot number above to return any unused product for a full refund to the company directly. Customers can call 1-800-385-0738 (Monday to Sunday 8 am to 5 pm pacific standard time) for instructions on the return and refund process.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[04/11/2013 - Firm Press Release - Affirm XL]