April 12, 2013

Affirm XL, Inc Recalls Affirm XL Dietary Supplement Tablet Due to Potential Health Risk

The Missouri Department of Health and Senior Services received information regarding a nationwide recall of Affirm XL, a dietary supplement tablet. The lot number is 1190001.

The product was found 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.

Affirm XL Tablet is sold nationwide in 10 count blister packs and single pill packs.

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.

The full recall can be found at ww.fda.gov/Safety/Recalls/ucm347558.htm?source=govdelivery.