Kanec USA recalls supplement at heels of FDA crackdown
DAVIE, Fla. As an example of how today’s Food and Drug Administration is enforcing dietary supplement regulation, Kanec USA earlier this month voluntarily recalled its Stud Capsule For Men.
The recall was announced following an FDA communication alerting Kanec to the fact that their sexual health dietary supplement had been found to be adulterated with sildenafil — and FDA-approved prescription medication used in the treatment of erectile dysfunction — which consequently reclassified the supplement as an unapproved new drug.
FDA posted that recall on its site earlier this week.
According to Kanec, Stud Capsule For Men were sold nationwide as a blister pack containing one capsule per unit of use 24-packs in a box in both retail outlets and as part of its direct response program, the company stated.
Perrigo wins unfair competition case
ALLEGAN, Mich. Perrigo announced Thursday that it won two favorable jury verdicts against Rexall Sundown in an unfair competition lawsuit that was brought in the U.S. Eastern District Court of New York.
The jury unanimously found that Perrigo’s statement, used on wholesalers’ and retailers’ store brand packaging for joint care products containing glucosamine and chondroitin, inviting consumers to compare the products with Rexall Sundown’s Osteo Bi-Flex, is not false and misleading and does not violate Section 43 of the Lanham Act.
In addition, the jury ruled in Perrigo’s favor on its false advertising counterclaim against Rexall Sundown under Section 43 of the Lanham Act based on a statement used by Rexall Sundown on packaging from 2006 to 2008. The jury determined that the Rexall Sundown statement was false and misleading and awarded Perrigo damages.
Perrigo’s chairman and CEO Joseph Papa stated, “This verdict is an important victory for store brands, U.S. retailers and consumers. The jury verdict confirms that statements on our wholesalers’ and retailers’ packaging, inviting consumers to compare store brand products to the higher priced national brand products are fair and legal. This kind of statement helps consumers to identify store brand products they want and helps them save as they choose the affordable, high-quality store brand option. We are gratified with this victory as another accomplishment in making quality healthcare more affordable to the U.S. consumer.”
Carex launches cast protectors
SIOUX FALLS, S.D. Carex Health Brands, leader in the development of in-home health products, introduced a new line of EZ Stretch cast protectors designed to keep casts and bandages completely dry while showering or bathing.
Made of highly durable and water-resistant material that’s very difficult to rip or puncture, both new EZ Stretch cast protectors easily stretch over a cast or bandage and tightly self-seal around the arm or leg.