FDA Roundup: September 24, 2024

SILVER SPRING, Md., Sept. 24, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

    --  Today, the FDA held a ribbon-cutting ceremony to highlight the
        completion of the 64,000 square foot expansion and renovation of the
        National Forensic Chemistry Center (NFCC) located in Cincinnati, Ohio.
        The goal of this revitalization effort was to improve FDA's mission
        readiness nationally and help attract and retain highly qualified
        employees. The NFCC is a specialty laboratory that serves as the FDA's
        national forensic laboratory providing specialized laboratory services
        in analytical chemistry and molecular/ microbiology related to
        adulteration/contamination, counterfeiting, and product tampering of FDA
        regulated commodities including drugs, dietary supplements, foods,
        cosmetics, veterinary feeds, and medical devices.

    --  On Monday, the FDA issued a safety advisory cautioning pet owners that
        samples of two Answers Pet Food products made by Lystn LLC tested
        positive for Salmonella, a third product tested positive for Listeria
        monocytogenes (L. mono), and a fourth product tested positive for
        Salmonella and L. mono. The FDA collected and tested unopened retail
        samples of products after receiving three consumer complaints of illness
        in dogs that ate the products. The affected products are sold frozen in
        4-pound (half-gallon) cartons and consist of certain batches of Answers
        Pet Food Raw Beef Detailed Formula for Dogs, Answers Pet Food Raw Beef
        Straight Formula for Dogs, and Answers Pet Food Straight Chicken Formula
        for Dogs. Information to help consumers identify affected batches of
        product can be found in the Product Information section of the advisory.
        These products should not be fed to pets.

    --  On Friday, the FDA approved isatuximab-irfc (Sarclisa) with bortezomib,
        lenalidomide, and dexamethasone for adults with newly diagnosed multiple
        myeloma who are not eligible for autologous stem cell transplant (ASCT).
        The most common adverse reactions (>=20%) were upper respiratory tract
        infection, diarrhea, fatigue, peripheral sensory neuropathy, pneumonia,
        musculoskeletal pain, cataract, constipation, peripheral edema, rash,
        infusion-related reaction, insomnia, and COVID-19 infection. Full
        prescribing information for Sarclisa will be posted on Drugs@FDA.
    --  On Friday, the FDA issued a safety advisory cautioning pet owners that
        FDA samples of five Darwin's Natural Pet Products raw cat and dog food
        made by Arrow Reliance, Inc. tested positive for Salmonella and a sixth
        FDA sample tested positive for Salmonella and L. mono. Affected products
        are sold in frozen 2-pound packages and consist of certain lots of
        Darwin's Natural Selections Antibiotic & Grain-Free Chicken Recipe for
        Cats and Darwin's Natural Selections Antibiotic & Grain-Free Chicken
        Recipe for Dogs. These product lots should not be fed to pets. For
        specific product information and to learn about potential signs of
        illness, see the FDA Advisory.

Additional Resources:

    --  FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration