MediPendant to be sold at Albertsons
PLYMOUTH MEETING, Pa. Medical Alarm Concepts has gained distribution of its MediPendant through Albertsons, the company announced Tuesday.
The MediPendant is a fully-monitored medical alarm system that allows users to speak and listen directly through the pendant.
“We are very pleased to be able to announce that Albertsons will now be offering our next generation personal emergency response system throughout their stores,” stated Medical Alarm Concepts CEO Howard Teicher. “Albertsons currently has over 250 pharmacy based stores and we believe our presence there will add tremendous value to our operations,” he said. “We expect this partnership will open up for additional distribution agreements with leading retail chains. Our technology of being able to have two-way call through the pendant with a range of 600 feet, versus being dependent on the competition’s base-unit inside, is receiving a lot of interest.”
Under the terms of the distribution agreement signed in March of this year, the company’s MediPendant alarm device will be offered by Albertsons in various locations throughout its grocery chain stores, including, but not limited to, the pharmacy section. The particular offering will also include one free month of monitoring services, and an associated “lock box” device that enables the EMT-certified operator to provide the access code to the ambulance personnel prior to arriving at the home. A lock box enables the ambulance personnel to avoid having to break into the home or waste time finding a source of entry.
Misrepresented hand-sanitizing gel seized by federal government
ROCKVILLE, Md. The Food and Drug Administration ordered the seizure of $230,000 in hand-sanitizing gel last week, the agency announced Friday.
The hand sanitizer, made by Puerto Rico Beverage and distributed by Lord Pharmaceutical/Bee International Distributors, currently is only available for sale in Puerto Rico. The product, which contains benzalkonium chloride, is not approved for sale in the U.S. market, the FDA stated.
The gel was marketed as a product that could kill 99.99% of viruses, bacteria and fungi. However, its safety and effectiveness have not been established. Additionally, the active ingredient, benzalkonium chloride, is not recognized as safe and effective for over-the-counter antifungal use, making it noncompliant with FDA’s final monograph for OTC topical antifungal drug products.
“The safety and effectiveness of the active ingredient in this product have not been demonstrated to the FDA,” stated Michael Chappell, FDA acting associate commissioner for regulatory affairs. “Thus, this product is an unapproved new drug and violates federal law. … This seizure action helps ensure that no consumers are harmed by this product.”
The product also represents that it prevents the disease caused by the H1N1 influenza virus, that it is effective against viruses and provides extended antimicrobial efficacy. The FDA is unaware of any scientific evidence to support these claims.
Moreover, the product, which is not labeled correctly, is misbranded under the law because its packaging does not list all inactive ingredients, and its label fails to contain the place of business of the manufacturer, packer or distributor.
The FDA inspected the product manufacturing facility between Aug. 19 and Sept. 28, 2009, and found numerous violations of U.S. current Good Manufacturing Practice requirements, including failure to have a Quality Control Unit; failure to maintain a clean and sanitary processing, packing and holding area; failure to conduct appropriate lab tests and many other violations.
Following that inspection, the firm agreed to recall and destroy its products but has failed to follow through on its commitments. This failure on behalf of the company led the government to request a seizure of the products.
On March 3, the FDA warned consumers not to use this product because it contained high levels of a bacterium, Burkholderia cepacia, that can cause serious infections in humans.
Slo-Niacin.com educates visitors about heart disease, cholesterol management
MAPLE GROVE, Minn. Upsher-Smith on Monday announced the launch of Slo-Niacin.com, an information portal for cholesterol management.
The site educates visitors about heart disease and includes "Cholesterol Basics," a guide to interpreting cholesterol levels and facts about common heart disease risk factors. The website also reviews recommendations on how to optimize cholesterol management, along with tips to leading a healthy lifestyle, including fitness, nutrition and how the integration of a supplement containing nicotinic acid, like the company’s Slo-Niacin brand, can support overall heart health.
"We know how important it is to be informed when it comes to managing overall heart health," stated Tina Fehr, product manager for Slo-Niacin. "The new website gives visitors easy access to credible information about cholesterol management, along with an improved store locator for the ultimate convenience on where to buy Slo-Niacin and how to obtain … coupons."