Stud Capsule For Men: Product adulterated with sildenafil which may interact with nitrates to lower blood pressure to dangerous levels

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Title: Stud Capsule For Men: Product adulterated with sildenafil which may interact with nitrates to lower blood pressure to dangerous levels
MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Stud Capsule For Men: Product contains Undeclared Drug Ingredient

Audience: Consumers, Pharmacists

Kanec USA and FDA notified healthcare professionals of a nationwide recall of Stud Capsule For Men [Lot #060607-01/060108-01, Exp 6-2013], after being informed by FDA that laboratory analysis of a sample found the product to be adulterated with sildenafil, an FDA approved drug. 

Use of this product 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 these conditions, and consumers may seek these types of products to enhance sexual performance. 

The products are sold as a blister pack containing one capsule per unit of use 24-packs in a Box. Lot number and expiration date appears on the seal. Consumers who have this recalled product in their possession should stop using them immediately.

Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm207630.htm


You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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