Original Post Summary Company Announcement Date: February 20, 2023 FDA Publish Date: February 20, 2023 Product Type: Food & BeveragesInfant Formula & FoodsFoodborne Illness Reason for Announcement: Potential Cronobacter sakazakii contamination Company Name: Reckitt Brand Name: Enfamil ProSobee Product Description: Enfamil Prosobee Simply Plant-Based Infant Formula in 12.9 oz containers Company Announcement ‘The company has…
Read MoreOriginal Post For Immediate Release: February 16, 2023 Statement From: Robert M. Califf, M.D., MACCCommissioner of Food and Drugs – Food and Drug Administration Addressing the drug overdose crisis and substance use disorder (SUD) is an issue of great concern for our nation and remains a top public health priority for the U.S. Food and…
Read MoreOriginal Post FDA is warning health care professionals and pharmacies to avoid using Hospira’s unapproved potassium phosphates drug product in pediatric patients because the aluminum exposure from this product is unsafe for this population. This product alone may produce daily aluminum exposures of up to twice the FDA-recommended limit for parenteral nutrition, with additional…
Read MoreOriginal Post The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The devices described in this recall notice are the same devices announced in the FDA safety communication Do Not Use Skippack Medical Lab SARS-CoV-2 COVID-19 Tests. Recalled Product…
Read MoreOriginal Post Anyone can save a life during an opioid overdose with naloxone, a front-line defense in the nation’s opioid crisis. Naloxone is a life-saving drug that, when sprayed into the nose or injected, quickly reverses the powerful effects of opioids during an overdose. Everyone who overdoses with opioids, whether with a prescribed medicine or…
Read MoreFDA Approves First Oral Treatment for Anemia Caused by Chronic Kidney Disease for Adults on Dialysis
Original Post For Immediate Release: February 01, 2023 Today, the U.S. Food and Drug Administration approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia (decreased number of red blood cells) caused by chronic kidney disease for adults who have been receiving dialysis for at least four months. Jesduvroq is not approved for patients…
Read MoreOriginal Post FDA announces Evusheld is not currently authorized for emergency use in the U.S. Update [1/26/2023] The U.S. Food and Drug Administration today revised the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. Based…
Read MoreOriginal Post Action FDA has approved Airsupra (albuterol and budesonide) inhalation aerosol for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in patients with asthma 18 years of age and older. Airsupra is a combination of albuterol (a beta-2 adrenergic agonist) and budesonide (a corticosteroid). It is the first combination…
Read MoreOriginal Post For Immediate Release: January 06, 2023 Today, the U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb) via the Accelerated Approval pathway for the treatment of Alzheimer’s disease. Leqembi is the second of a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease. These medications represent an important advancement in the…
Read MoreOriginal Post By: Susan T. Mayne, Ph.D., Director, Center for Food Safety and Nutrition Over this last year, some families around our country faced challenges finding infant formula, a product that serves as the sole source of nutrition for many infants in the U.S. What started with reports of illnesses in infants led to a…
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