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Food and Drug Administration

Recall
National

B. Braun Medical Inc. Recalls Sodium Chloride Injection: What You Need to Know

August 10, 2024August 9, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration announced that B. Braun Medical Inc. is recalling two lots of 0.9% Sodium Chloride for Injection USP 1000 mL E3 containers. This …

B. Braun Medical Inc. Recalls Sodium Chloride Injection: What You Need to Know Read More

Premium Infant Formula with Iron Milk-Based Powder
National

Health Alert: Recall of Infant Formula due to Excess Vitamin D Levels

August 9, 2024August 9, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) announced that Perrigo Company plc initiated a voluntary recall at the retailer and warehouse level of three lots within one batch, …

Health Alert: Recall of Infant Formula due to Excess Vitamin D Levels Read More
Yummy Swirly Ices, various flavors
National

FDA Announces Recall of Yummy Swirly Ices Due to Potential Milk Contamination

August 8, 2024August 8, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) has announced that Yummy Foods, based in Edison, NJ, is recalling its Yummy Swirly Ices line due to potential milk contamination. …

FDA Announces Recall of Yummy Swirly Ices Due to Potential Milk Contamination Read More

Heparin Sodium in 0.9% Sodium Chloride Injection
National

Baxter Recalls Heparin Sodium Injection Over Elevated Endotoxin Levels

August 8, 2024August 7, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) announced that Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection due to …

Baxter Recalls Heparin Sodium Injection Over Elevated Endotoxin Levels Read More
Coconutmilk Chocolate Almond Crunch Frozen Dessert
National

FDA Issues Recall for Non-Dairy Frozen Dessert Due to Undeclared Allergen

August 7, 2024August 7, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) has announced a recall by G.S. Gelato & Desserts, Inc. of a limited amount of Full Circle Market Coconutmilk Chocolate Almond Crunch …

FDA Issues Recall for Non-Dairy Frozen Dessert Due to Undeclared Allergen Read More

Ocugen
Products and Services

Ocugen Receives FDA Approval for Expanded Access Program for Retinitis Pigmentosa Treatment

August 7, 2024August 6, 2024 - by Timothy Alexander

MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) has received approval from the Food and Drug Administration to begin its expanded access program (EAP) for the treatment of adult patients with …

Ocugen Receives FDA Approval for Expanded Access Program for Retinitis Pigmentosa Treatment Read More
Food and Drug Administration
Regional

FDA Utilizes AI/ML for Drug Therapy Decision-Making

August 6, 2024August 4, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) recently published a groundbreaking analysis on the use of artificial intelligence and machine learning (AI/ML) in drug therapy decisions. This marks …

FDA Utilizes AI/ML for Drug Therapy Decision-Making Read More

Bikano Moong Dal 350g
National

FDA Issues Recall for Bikano Moong Dal Over Salmonella Concerns

August 6, 2024August 6, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) has announced a recall of 640 packs of “Bikano Moong Dal 350g” by Thal Golden Spices Inc. of Hayward, California. The …

FDA Issues Recall for Bikano Moong Dal Over Salmonella Concerns Read More
Woman feeding a baby
National

FDA Issues Safety Alert on Crecelac Infant Formula Due to Nutrient Imbalances and Bacterial Contamination

August 6, 2024August 6, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) recently issued an urgent safety alert to warn consumers about the potential risks associated with Crecelac Infant Powdered Goat Milk Infant …

FDA Issues Safety Alert on Crecelac Infant Formula Due to Nutrient Imbalances and Bacterial Contamination Read More
Johnson & Johnson
Regional

FDA Approves DARZALEX FASPRO® for Newly Diagnosed Multiple Myeloma Patients

August 6, 2024August 5, 2024 - by Timothy Alexander

HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) recently approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and …

FDA Approves DARZALEX FASPRO® for Newly Diagnosed Multiple Myeloma Patients Read More

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