The U.S. Food and Drug Administration today approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.
FDA warns against certain uses of asthma drug terbutaline for preterm labor
The U.S. Food and Drug Administration is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor due to the potential for serious maternal heart problems and death. In addition, oral terbutaline tablets should not be used for prevention or treatment of preterm labor. The FDA is requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information (labeling) to warn against these uses.
Upsher-Smith Laboratories Announces The Voluntary Nationwide Recall Of Jantoven® Warfarin Sodium Tablets, USP, 3mg, Due To Mislabeled Bottles
Upsher-Smith Laboratories, Inc., of Maple Grove, Minnesota is voluntarily recalling one lot (lot #284081) of Jantoven® Warfarin Sodium, USP, 3mg Tablets, an anticoagulant with an expiration date of September 2012, NDC # 0832-1214-00. The company is initiating the recall as a precautionary measure after a single bottle labeled as Jantoven® Warfarin Sodium, USP, 3mg Tablets was found to contain tablets at a higher, 10mg strength before it was dispensed.
U.S. Marshals seize Auralgan Otic Solution
U.S. Marshals, at the request of the U.S. Food and Drug Administration, yesterday seized all lots of Auralgan Otic Solution, a prescription drug used to treat pain and inflammation associated with ear infections.
Prime Choice Foods Corporation Voluntarily Recalls Certain Lots Of Garden Of Eatin’® Multi Grain Tortilla Chips Due To The Presence Of Undeclared Allergens
Prime Choice Foods announced that it is taking the precautionary measure of recalling certain lots of Garden of Eatin’® Multi Grain Sea Salt Tortilla Chips (9 oz bags), Garden of Eatin’® Multi Grain Everything Tortilla Chips (9 oz bags) and Garden of Eatin’® Multi Grain Blues Sea Salt Tortilla Chips (9 oz bags) due to the presence of undeclared wheat and soy.
Consumers who have an allergy or severe sensitivity to wheat or soy run the risk of serious or life-threatening allergic reaction if they consume these products.
FDA seeks to invest in foodborne illness prevention, medical product safety and countermeasures
The U.S. Food and Drug Administration 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. The FY 2012 request covers the period of Oct. 1, 2011, through Sept. 30, 2012.
FDA finalizes regulation for certain software, hardware used with medical devices
Today, the FDA issued a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.
FDA approves first 3-D mammography imaging system
Mammography, screening, 3-D
FDA clears test to help patients with kidney transplants
Zortress, kidney, transplant
f’real® foods Expands Voluntary Recall Of Strawberry Banana Smoothies Due To Potential Peanut Content
– f’real® foods announced today that it has expanded its voluntary recall of f’real® Strawberry Banana Smoothies (Lot # 06/21/2012) produced at Smith Dairy Products Company in Orrville, Ohio. The expansion to additional states is due to customer input regarding the extent of their distribution areas.