Kanec USA Inc., just issued a voluntary, nationwide recall of its <"https://www.yourlawyer.com/practice_areas/defective_drugs">Stud Capsule for Men, the U.S. Food & Drug Administration (FDA) just announced. Kanec is located at 5061, South State Road 7. Ste 602, Davie FL 33314.
The recall involves Stud Capsule For Men Lot #060607-01/060108-01 Exp 6-2013 and was initiated after the FDA discovered that laboratory analysis of the Stud Capsule Lot 060607-01/060108-01 Exp 6-2013 sample found the product to be adulterated with Sildenafil, an FDA approved drug used in the treatment of Erectile Dysfunction (ED). This adulturation makes the product an unapproved new drug.
Use of Kanec’s Stud Capsule for Men 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 and ED is a common problem in men with these conditions; consumers may seek these types of products to enhance sexual performance.
Stud Capsule For Men are sold nationwide as a blister pack containing one capsule per unit of use and with 24-packs in a box. The lot number and expiration date appears on the seal. Consumers who have Stud Capsule For Men Lot 060607-01/060108-01 Exp 6-2010 in their possession should stop using them immediately.
In the event of any adverse side effects due to the consumption of these products, consumers should contact a physician immediately. Any adverse events that may be related to the use of these products should be reported to the FDA’s Med Watch Program by fax at 1-800-FDA-0178; by mail at Med Watch, HF-2, FDA, 5600 Fishers Lane, Rockville, Maryland, 20852-9787; or via the Med watch website at http:www.fda.gov/safety/medwatch/default.htm
Kanec is advising consumers to return any unused Stud Capsule For Men, to the retail location from which it was purchased or to it directly if it was purchased from Kanec as a part of its Direct Response Program. Consumers can send unused capsule directly to Kanec at: Kanec USA Inc.; 5061 South State Road 7, U602; Davie, Florida; 33314. Kanec can be reached direct by telephone at 954-583-5840. Its fax number is 954-583-5885.
