FDA Roundup: January 2, 2024

SILVER SPRING, Md., Jan. 2, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

On Dec. 31, 2023, the FDA alerted parents, caregivers and health care providers that Reckitt/Mead Johnson Nutrition voluntarily recalled certain Nutramigen Hypoallergenic Infant Formula Powder products due to possible Cronobacter sakazakii contamination. No illnesses have been reported to date in connection with this recall, and it is likely most of the product that was distributed in the U.S. has already been consumed. Consumers who have Nutramigen Hypoallergenic Infant Formula Powder with certain batch codes should stop using it and throw it away or contact Reckitt/Mead Johnson Nutrition for a refund.

On Dec. 28, 2023, the FDA issued a new guidance to help drug manufacturers limit consumers’ and patients’ exposure to unacceptable levels of benzene in certain drug products. The guidance provides manufacturers with recommendations for testing and documentation related to reformulation of drug products that use carbomers manufactured with benzene, taking into consideration the various routes of administration and dosage forms of affected drug products.

On Dec. 27, 2023, the FDA also revised the draft guidance for industry, Quality Considerations for Topical Ophthalmic Drug Products, to articulate important changes, including added information about product sterility and preservative use, as well as a clarified scope regarding drug products that are not marketed under section 505G of the Federal Food, Drug and Cosmetic Act, or pursuant to an FDA approval or licensure. To read the revised guidance and for more information on how to submit comments to the docket, visit the guidance page.

On Dec. 27, 2023, the FDA issued a Letter to Clinical Laboratory Staff and Health Care Providers to remind providers and clinical laboratory staff about the potential for false reactive (false positive) results in herpes simplex virus type 2 (HSV-2) serological tests for genital herpes.

On Dec. 22, 2023, the FDA issued a safety alert advising restaurants and retailers not to serve or sell, and consumers not to eat, certain oysters from British Columbia, Canada that are potentially contaminated with Campylobacter jejuni.

 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