Global Wellness recalls lots of Via Extreme supplement due to presence of undeclared drug
HOLLYWOOD, Fla. — Global Wellness on Tuesday initiated a voluntary nationwide recall of its Via Extreme ultimate sexual enhancer dietary supplement for men.
The product — a bottle containing six blue-colored capsules per package — was distributed throughout the United States, Puerto Rico and Canada to Internet and retail consumers, the company reported.
Global Wellness is recalling only lots 809013 and 806030; the recall does not affect sales and distribution of Slim Extreme Gold and Gelslim, the company stated.
Global Wellness initiated the recall after having been informed by representatives of the Food and Drug Administration that laboratory analysis conducted by the FDA for lots 809013 and 806030 found that the product contains sulfoaildenafil methanesulfonate, sulfosildenafil and dimethylsildenafil analogs of sildenafil. Sildenafil is the active ingredient of Viagra, a fact that makes Global’s Via Extreme lots technically unapproved drugs.
Sildenafil 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. Additionally, the product may cause such side effects as headaches and flushing.
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FDA: Wyldewood Cellars’ elderberry juice products tout unapproved disease claims
SILVER SPRING, Md. — The Food and Drug Administration has seized elderberry juice products that have been distributed by Wyldewood Cellars.
The FDA said that the products were seized from the Peck, Kan.-based company because they were unapproved, misbranded drugs that violated the agency’s Federal Food, Drug and Cosmetic Act by stating that elderberry juice concentrate cures, treats or prevents various disease conditions, including AIDS, diabetes and flu.
The complaint was filed on May 27 in the U.S. District Court of Kansas.
“Products with unapproved disease claims are dangerous because they may cause consumers to delay or avoid legitimate treatments,” the FDA’s associate commissioner for regulatory affairs Dara Corrigan said. “The FDA is committed to protecting consumers from unapproved products on the market. We will continue to take actions against companies that do not meet federal standards for safety, effectiveness and quality.”
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Insulet acquires Neighborhood Diabetes
BEDFORD, Mass. — A company that develops insulin-pump technology without tubing, such as the OmniPod insulin management system, has acquired a durable medical equipment distributor that specializes in direct-to-consumer sales of diabetes supplies.
Insulet said its acquisition of Woburn, Mass.-based Neighborhood Diabetes — which serves more than 60,000 customers with Type 1 and Type 2 diabetes with blood-glucose testing supplies, insulin pumps, pump supplies and pharmaceuticals — would "advance Insulet’s mission to make the lives of people living with diabetes easier." The acquisition would provide Insulet with a full suite of diabetes management product offering, including the OmniPod insulin management system, as well as blood-glucose testing supplies, continuous glucose-monitoring sensors and insulin.
"Our customers consistently express interest in purchasing additional diabetes management supplies from us. Now we will be able to directly provide them with test strips, sensors and insulin," Insulet president and CEO Duane DeSisto said.
The acquisition carries a price tag of about $63 million in cash and stock.
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