FDA seizes probiotic products from UAS Labs
SILVER SPRING, Md. — The Food and Drug Administration reported Tuesday that U.S. marshals seized probiotic products from UAS Labs that were being marketed as drugs.
The FDA said UAS Labs products, including DDS Acidophilus, DDS Plus, Probioplus DDS, DDS Junior and Cran-Gyn DDS, claimed they could treat or prevent colds, flu, respiratory infections, urinary tract infections, yeast infections, ulcers and high cholesterol. These claims violate the Federal Food, Drug, and Cosmetic Act, which restricts the use of disease claims to approved — or otherwise legally marketed — drugs.
The company, based in Eden Prairie, Minn., markets the products in the United States and internationally.
HDMA announces 2011 DIANA winners
PHOENIX — The Healthcare Distribution Management Association on Monday awarded eight leading pharmaceutical and consumer product manufacturers through the presentation of its annual Distribution Industry Awards for Notable Achievements in health care.
“The 2011 DIANA honorees set the standard for excellence in the healthcare supply chain, introducing innovative new products to the marketplace and forging lasting partnerships with their peers in the healthcare distribution industry,” stated HDMA president and CEO John Gray. “These winning companies lead the way with their continuing commitment to creativity and collaboration, and we congratulate them on their achievements.”
The 2011 DIANA winners are:
Best New Pharmaceutical Product Introduction or Product Promotion Awards — Branded Pharmaceutical Products: Boehringer Ingelheim Pharmaceuticals for Pradaxa; Generic Pharmaceutical Products: Sandoz for Enoxaparin;
Best Overall Manufacturer Awards — Consumer product manufacturer with sales to healthcare distributors of less than $10 million: Omron Healthcare;
Consumer product manufacturer with sales to healthcare distributors of more than $10 million: Roche Diagnostics;
Generic product manufacturer with sales to healthcare distributors of less than $100 million: Lupin Pharmaceuticals;
Generic product manufacturer with sales to healthcare distributors of more than $100 million: Watson Pharmaceuticals;
Branded pharmaceutical product manufacturer with sales to healthcare distributors of less than $300 mllion: Upsher-Smith Labs; and
Branded pharmaceutical product manufacturer with sales to healthcare distributors of more than $300 million: Takeda Pharmaceuticals North America.
HDMA has awarded the DIANA to manufacturers for developing innovative new product introductions and promotions for the healthcare distribution industry. The awards also recognize companies that continually foster strong trading partner relationships with the Association’s primary distributor members by creating exceptional business practices that advance trade relations and benefit the entire healthcare supply chain.
Award winners were selected by HDMA distributor members. For the Best Overall Manufacturer awards, winners were chosen on criteria ranging from developing collaborative trading partner relationships to creating marketing programs that benefit the supply chain and commitment to excellence. Among other criteria, the Best New Product Introduction or Promotion winners were judged on their ability to create innovative marketing programs, their level of market performance, promotional support and operational excellence.
The winners were announced at the association’s 2011 Business & Leadership Conference.
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.