PERRYSBURG, Ohio—Glow Industries Inc. is conducting a national recall of a dietary supplements, after FDA testing found the products were adulterated with pharmaceutical drugs. The men’s sexual enhancement product, sold as Mr. Magic Male Enhancer from Don Wands, was found to contain hydroxythiohomosildenafil and sulfoaildenafil, a pharmaceutical similar to an active ingredient in an FDA-approved drug for male erectile dysfunction (ED). The presence of the drug compound makes the product an unapproved new drug; sulfoaildenafil is also not listed on the product label. The drug can adversely interact with other pharmaceuticals, causing dangerous drops in blood pressure.
Affected lots include 9041401, 251209 and 8121904; the products were sold in bottles and capsule cards. Consumers can call (419) 350-2726 for instructions on product return and credit; the company is notifying distributors and retailers directly using a letter and phone calls to arrange for return of recalled products.
The voluntary recall is being conducted as a precautionary measure, as the company noted no illnesses or adverse effects have been reported to the company to date in connection with the product. Adverse reactions or quality problems associated with use of the product can be reported via FDA’s MedWatch Adverse Event Reporting System.
* FDA: Glow Industries, Inc. Issues Nationwide Recall of Mr. Magic Male Enhancer from Don Wands Amended