• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Glow Industries, Inc. Issues Nationwide Recall of Mr. Magic Male Enhancer from Don Wands Amended
 

 

Contact:
(419) 350-2726

 

FOR IMMEDIATE RELEASE -- August 18, 2010 - 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:

Product NameLot CodeUPC Code
Mr. Magic 1 ct. Capsule Card9041401 and 251209648658123001
Mr. Magic 3 ct. Capsule Bottle9041401 and 8121904648658123018
Mr. Magic 6 ct. Capsule Bottle9041401 and 8121904648658123025
Mr. Magic 12 ct. Capsule Bottle9041401 and 8121904648658123032
Mr. Magic Display of 24; 1 ct. Capsule Cards9041401 and 251209648658123043
Mr. Magic 20 ct. Capsule Bottle9041401 and 8121904648658123056

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.

The 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 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.

 

###

Photos: Product Labels

RSS Feed for FDA Recalls Information [what's this?]