Glow Industries, Inc., of Perrysburg, Ohio, just announced that it is initiating a voluntary, nationwide recall of its <"http://www.yourlawyer.com/practice_areas/defective_drugs">â€œMr. Magic Male Enhancer from Don Wands,â€ the U.S. Food and Drug Administration (FDA) just announced.
Glow Industries, Inc. is conducting this voluntary recall after being informed by the agency that lab analysis revealed that 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 and involves the following:
Mr. Magic 1 ct. Capsule Card: Lot Code 9041401 and 251209 and UPC 648658123001
Mr. Magic 3 ct. Capsule Bottle: Lot Code 9041401 and 8121904 and UPC 648658123018
Mr. Magic 6 ct. Capsule Bottle: Lot Code 9041401 and 8121904 and UPC 648658123025
Mr. Magic 12 ct. Capsule Bottle: Lot Code 9041401 and 8121904 and UPC 648658123032
Mr. Magic Display of 24; 1 ct. Capsule Cards: Lot Code 9041401 and 251209 and UPC 648658123043
Mr. Magic 20 ct. Capsule Bottle: Lot Code 9041401 and 8121904 and UPC 648658123056
The recall is being conducted as a precautionary measure and no illnesses or adverse effects have been reported to the company, to date, in connection with the product. Of note, the productâ€™s undeclared ingredients 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 conditions, and consumers may seek types of products to enhance sexual performance.
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 8:00 a.m. and 5:00 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 telephone calls to arrange for return of any 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].