The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF).

SILVER SPRING, Md., Sept. 30 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever ...

Over 300 foreign manufacturers have been placed on the Import Alert #66-41 “Red List”, charged with promoting unapproved drugs to people in the U.S. A company is placed on IA 66-41 when FDA believes it is marketing an unapproved drug by mail order, when FDA field agents determine that ...

WASHINGTON , April 29 /PRNewswire-USNewswire/ -- Schwarz Pharma Inc. will pay $22 million to resolve False Claims Act allegations that the company failed to advise the Centers for Medicare and Medicaid Services (CMS) that two unapproved products did not qualify for coverage under federal health care ...

The U.S. Food and Drug Administration announced that a consent decree has been filed against the device manufacturer, STERIS Corp. of Mentor, Ohio. The decree stops the company from distributing unapproved and misbranded devices used to sterilize heat-sensitive instruments and medical devices. It prohibits the distribution of the STERIS System ...

The National Minority Quality Forum (The Forum) is launching a new public information campaign aimed to help educate consumers, physicians, and policymakers about the risks associated with prescribing and taking unapproved drugs that have not been subjected to the rigorous Food and Drug Administration’s (FDA) review and approval process.

As reported in today's Wall Street Journal, the more than 2 million Americans with atrial fibrillation are now on notice that the over-zealous marketing tactics and incentives by manufacturers of expensive medical devices which are not approved by the U.S. Food and Drug Administration (FDA) for the treatment of atrial ...

WASHINGTON , March 11 /- As reported in today's Wall Street Journal, the more than 2 million Americans with atrial fibrillation are now on notice that the over-zealous marketing tactics and incentives by manufacturers of expensive medical devices which are not approved by the ...

A complaint filed in federal court last week "alleges Medtronic Inc. illegally marketed a relatively obscure medical device called a biliary stent in ways not approved by federal regulators," The (Minneapolis-St. Paul) Star Tribune reports. "The complaint was filed in U.S. District Court in Boston by two former employees who ...

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized 79 ozone generators, models AOS-1M and AOS-1MD, from Applied Ozone Systems of Auburn, Calif. The seized goods, which are medical devices, are valued at $75,900.

FDA inspection shows devices produced under poor manufacturing condition; pose public health risk SILVER SPRING, Md. , Jan. 29 /PRNewswire-USNewswire/ -- At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized 77 ozone generators, ...

SILVER SPRING, Md., Jan. 8 /PRNewswire-USNewswire/ -- Sybaritic Inc., a medical device maker, has agreed to stop producing and distributing its medical products used in laser surgery, dermatology, and spa treatments until it is in compliance with FDA quality standards. The products are considered to be unapproved medical devices as ...