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Food and Drug Administration

Food and Drug Administration
National

FDA Announces Nationwide Correction of Breas Medical Ventilators Due to Formaldehyde Exposure Risk

August 11, 2024August 10, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration (FDA) has announced that Breas Medical is initiating a nationwide correction of 8,186 Vivo 45 LS ventilator devices. Internal testing identified the …

FDA Announces Nationwide Correction of Breas Medical Ventilators Due to Formaldehyde Exposure Risk Read More

Dunking Cookies Chocolate Chip
National

Too Good Gourmet Recalls Meijer Dunking Cookies Due to Undeclared Milk Allergen

August 11, 2024August 10, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration announced that Too Good Gourmet of San Lorenzo, CA, is recalling Meijer Dunking Cookies Chocolate Chip owing to undeclared milk. This poses …

Too Good Gourmet Recalls Meijer Dunking Cookies Due to Undeclared Milk Allergen Read More
Prime Foods Steam Buns
National

Prime Foods Recalls Egg Custard Steamed Buns Due to Undeclared Sesame — Check Your Freezer Now!

August 11, 2024August 10, 2024 - by Maryann Pugh

WASHINGTON, D.C. — The Food and Drug Administration has announced a recall by Prime Foods Processing LLC of Brooklyn, NY, involving 477 cases of two varieties of Egg Custard Steamed …

Prime Foods Recalls Egg Custard Steamed Buns Due to Undeclared Sesame — Check Your Freezer Now! Read More

Cold Smoked Capelin
National

FDA Alert: Recall of Cold Smoked Capelin – Potential Botulism Risk

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

WASHINGTON, D.C. — The Food and Drug Administration announced that North Fish USA Inc. of Hallandale, FL, is recalling 9-ounce packages of “Cold Smoked Capelin” because the product was found …

FDA Alert: Recall of Cold Smoked Capelin – Potential Botulism Risk Read More
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

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