Sexual Virility Max (Bulk drug product)
Lot 10090571, Product code 30535-B01
Recalling Firm: ABCO Laboratories, Inc., Fairfield, CA
Manufacturing Firm: ABCO Laboratories, Inc. Fairfield, CA
REASON FOR RECALL
Marketed without an approved NDA/ANDA: FDA lab analysis found the product to contain sulfoaildenafil and sulfosildenafil, analogues of sildenafil, the active ingredient in a FDA approved drug used to treat erectile dysfunction (ED), making this product an unapproved new drug.