FDA Roundup: September 24, 2024

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Sep 24, 2024, 15:45 ET

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
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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.

SOURCE U.S. Food and Drug Administration