The U.S. Food and Drug Administration today approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.
FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas
The U.S. Food and Drug Administration is reminding health care professionals and consumers about safety concerns with all sterile-use drug products made and distributed by Downing Labs LLC, doing business as NuVision Pharmacy, in Dallas, Texas. Health care professionals should not use any NuVision/Downing Labs sterile products for their patients because the firm cannot ensure the safety or quality of these products. Administration of a non-sterile drug product may result in serious and potentially life-threatening infection or death.
Publix Recalls Private Label Jalapeno Bagels
Out of an abundance of precaution, the company is issuing a voluntary recall for Publix Jalapeno Bagels, which are sold in either the self-service bins or artisan cases in the bakery department, and may contain pieces of glass and small stones.
The Publix Jalapeno Bagels were distributed to Publix store locations in Alabama, Florida, Georgia and South Carolina. Publix stores in Tennessee and North Carolina are not impacted by this recall.
Plum Organics Voluntarily Recalls Little Cremes Organic Rice Milk Snacks Due to Potential Choking Hazard
Plum Organics is voluntarily recalling its Little Cremes organic rice milk snacks line after it was found that the product has the potential to cause choking. The small, bite-sized snack pieces are made to soften in a child’s mouth in less than 20 seconds making them easy to swallow.
Mars Chocolate North America Issues Allergy Alert Voluntary Recall on Undeclared Peanuts and Eggs in TWIX® Bites 7oz Stand Up Pouch
Today, Mars Chocolate North America announced a voluntary recall of its TWIX® Brand Unwrapped Bites 7 oz. Stand Up Pouch with the code date: 421BA4GA60. Fewer than 25 cases of the stand-up pouches in this single lot code may contain product containing peanuts and eggs without listing them on the ingredient label.
Pharmacy Creations Issues Voluntary Recall of Four Product Lots With Limited Distribution in Florida, New Jersey, New York, and Puerto Rico Due to Potential Non-Sterility
Pharmacy Creations has voluntarily recalled four product lots (see below) following testing results conducted by Front Range, Inc., its former independent testing laboratory, that indicated that the product lots may have the potential of not being sterile. Pharmacy Creations no longer uses Front Range, Inc. for testing of any kind for any of its formulations.
FDA allows marketing of the first test to assess risk of developing acute kidney injury
Today the U.S. Food and Drug Administration allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following the administration of the test. Early knowledge that a patient is likely to develop AKI may prompt closer patient monitoring and help prevent permanent kidney damage or death.
U.S. Marshals seize drug products from Flawless Beauty
Various unapproved and improperly labeled drug products that were marketed, sold and distributed via the Internet by Flawless Beauty LLC, of Asbury Park, New Jersey, have been seized by U.S. Marshals at the request of the U.S. Food and Drug Administration and the U.S. Attorney for the District of New Jersey. These products, including injectable drug products, were marketed, sold and distributed to individuals, retail outlets, health spas and clinics.
Tullia’s Recalls Sauce Because of Possible Health Risk
Tullia’s is recalling Italian Meatless Pasta Sauce code 530140. This recall has been initiated because a records review by the Washington State Department of Agriculture revealed that one batch of sauce produced with the 530140 code had a pH level high enough to allow the growth of Clostridium botulinum. If present, this organism can cause botulism, a serious and potentially fatal foodborne illness.
FDA approves Keytruda for advanced melanoma
The U.S. Food and Drug Administration today granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.