Glow Industries, Inc., Perrysburg, OH, announced today that it is initiating a voluntary nationwide recall of the company’s product sold under the name of Mr. Magic Male Enhancer from Don Wands. Glow Industries, Inc. is conducting this voluntary recall after being informed by the Food and Drug Administration (FDA) that lab analysis has found the Mr. Magic Male Enhancer from Don Wands capsules to contain Hydroxythiohomosildenafil and Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making Mr. Magic Male Enhancer an unapproved new drug. These active ingredients are not listed on the product label. Product manufactured containing lot numbers 9041401, 251209 and 8121904 are included in this recall.
The Mr. Magic Male Enhancer recall includes:
The recall is being conducted as a precautionary measure. No illnesses or adverse effects have been reported to the company to date in connection with the product.
Glow Industries, Inc. advises any customer in possession of Mr. Magic Male Enhancer from Don Wands capsules to call (419) 350-2726, between the hours of 8 a.m and 5 p.m, Monday through Friday, Eastern Standard Time for instructions on the product return and credit process. Glow Industries, Inc. is notifying its distributors and retailers by a recall letter and phone calls to arrange for return of recalled product in their possession.
Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].
Customers with questions should contact Glow Industries, Inc. at (419) 350-2726.