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Recent news from the US Food and Drug Administration.
Click "read more" links to see the full article at the FDA
website. For the most up-to-date headlines, check out the FDA
Newsroom.
FDA
Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now
CFC-propelled albuterol inhalers are being phased out because they are
harmful to the environment by contributing to depletion of the ozone layer
above the Earth's surface. [ Read
more ]
FDA
Requests Recall of Xiadafil VIP Tabs
The U.S. Food and Drug Administration today requested that SEI Pharmaceuticals,
of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles
(Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because
these products contain a potentially harmful, undeclared ingredient that
may dangerously affect a person's blood pressure and can cause other life-threatening
side effects. [ Read
more ]
FDA
Warns Consumers Against Using Mommy's Bliss Nipple Cream
The U.S. Food and Drug Administration is warning consumers not to use
or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc.,
because the product contains potentially harmful ingredients that may
cause respiratory distress or vomiting and diarrhea in infants. [ Read
more ]
New
Efforts to Help Improve Medical Products for Patient Safety and Quality
of Medical Care
HHS Secretary Mike Leavitt today announced efforts underway at the U.S.
Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid
Services (CMS) that will complement each other to improve patient safety
and the quality of medical care. [ Read
more ]
FDA
Approves Entereg to Help Restore Bowel Function Following Surgery
The U.S. Food and Drug Administration approved Entereg (alvimopan) today
to accelerate the restoration of normal bowel function in patients 18
years and up who have undergone partial large or small bowel resection
surgery. Entereg will be used in hospitalized patients who can receive
no more than 15 doses. [ Read
more ]
FDA
Obtains Permanent Injunction Against Scientific Laboratories, Inc.
The U.S. Food and Drug Administration (FDA) today announced that Scientific
Laboratories Inc., and its president, Rajeshwari Patel, and chief executive
officer, Amit Roy, have signed a Consent Decree of Permanent Injunction
and are barred from manufacturing and distributing drug products until
they bring their manufacturing operations into compliance with law and
obtain approval for their products. [ Read
more ]
FDA
Shuts Down Seafood Processing Company, Requires Products Be Recalled
The U.S. Food and Drug Administration today directed Hope Food Supply
Inc., a Pasadena, Texas, food processing company, to shut down and immediately
recall all products manufactured from its Texas facility since 2007. [
Read
more ]
FDA
Takes Action Against Cream Cheese Companies, Executives
The U.S. Food and Drug Administration today announced the shut down of
cream cheese and seafood operations at Lifeway Foods, Inc. and its subsidiary,
LFI Enterprises, Inc., both Illinois companies, until they are found compliant
with food-safety laws. [ Read
more ]
Manufacturer
Removes Remaining Stocks of Trasylol
Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company
will begin removing the remaining Trasylol stock from the U.S. market,
most of which is in warehouses and hospital or physicians' stock. The
FDA will work with Bayer to ensure a smooth and complete process. [ Read
more ]
FDA
Approves New Formulation of Coagulation Therapy
he U.S. Food and Drug Administration has approved a new formulation of
the genetically engineered version of Factor VIIa, a plasma protein essential
for the clotting of blood. The new formulation allows the product to be
stored at room temperature (up to 81 degrees Fahrenheit) for up to two
years. [ Read
more ]
FDA
Approves First Generic Ropinirole
The U.S. Food and Drug Administration has approved the first generic versions
of Requip (ropinirole hydrochloride) tablets for the treatment of moderate
to severe Restless Legs Syndrome. [ Read
more ]
FDA
Completes Final Analysis of "Total Body Formula" and "Total
Body Mega Formula" Products
The U.S. Food and Drug Administration's final analysis of certain flavors
of "Total Body Formula" and "Total Body Mega Formula"
has detected hazardous amounts of chromium. [ Read
more ]
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