Upsher-Smith Laboratories, Inc. is voluntarily recalling one lot of Jantoven Warfarin Sodium, an anticoagulant, because one bottle in the lot contained incorrect dosages.

U.S. Marshals, at the request of the FDA, seized all lots of Auralgan Otic Solution, a prescription drug used to treat pain and inflammation associated with ear infections, from Integrated Commercialization Solutions Inc. (ICS) in Brooks, Ky .

The FDA is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention of, or for prolonged (beyond 48-72 hours) treatment of preterm labor.

FDA issues recall of Triad Group's Triad Sterile Lubricating Jelly because it may not be sterile.

Prime Choice Foods announced that it is taking the precautionary measure of recalling certain lots of  some of its tortilla chip products due to undeclared ingredients.

The U.S. Food and Drug Administration has issued a recall on Medtronic products SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits.

The U.S. Food and Drug Administration (FDA) today announced that it has cleared a test to help manage potential organ rejection in kidney transplant patients.

Today, the FDA announced a final rule that provides a less burdensome path to market for certain hardware and software products used with medical devices.

The FDA today approved the Selenia Dimensions System, the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis.

The U.S. Food and Drug Administration (FDA) is requesting a budget of $4.3 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2012 budget — a 33 percent increase over the FDA enacted budget for FY 2010.