FDA News

Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle

Foster City, Calif., September 20, 2024 - Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in Read More (external link)...

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ANSWERS Pet Food Voluntarily Withdrawals Certain Limited Lots of Beef and Chicken Dog Foods Due to Potential Salmonella and Listeria

Lystn, LLC d.b.a./ANSWERS Pet Food of Fleetwood, PA, is voluntarily withdrawing certain lots of ANSWERS Detailed Beef Formula for Dogs, ANSWERS Straight Beef Formula for Dogs, and ANSWERS Straight Chicken Formula for Dogs out of an abundance of caution after samples collected by the U.S. Food and Dr Read More (external link)...

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Avole Inc. Emite Aviso de Retiro del Mercado su Producto Bacalaitos Criollos Mezcla para Freír Bacalao por Falta de Declaración del Nombre Común Pescado (Pollock)

Avole Inc., localizado en San Sebastián, Puerto Rico está retirando del mercado fundas de 7 onzas de Bacalaitos Criollos Mezcla para freír Bacalao, porque pueden contener falta de declaración del nombre común Pescado (Pollock) en la declaración de ingredientes o contenido. Las personas que tienen al Read More (external link)...

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Grace Imports, LLC Issues Allergy Alert of Undeclared Wheat in Kara Boondh, Kerala Mixture and Spicy Murukku

Grace Imports, LLC., of Tucker, GA - September 20, 2024, is voluntarily recalling 250g bags of Kara Boondhi, Batch No. 2Al488 UPC 8 904123 53706, 300g bags of Kerala Mixture, Batch No. 2Al564 UPC 8 904123 500329 and 250g bag Spicy Murukku Batch No. 2Al504 UPC 8 904123 because these products contain Read More (external link)...

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HP Hood LLC Recalls Select Units of 96 oz Refrigerated Lactaid Milk Due to Possible Almond Allergen

HP Hood LLC is recalling five SKUs of 96 oz containers of LACTAID Milk because the product may contain trace amounts of almond, which is not listed on the label. People who have an allergy or severe sensitivity to almonds may run the risk of serious or life-threatening allergic reaction if they cons Read More (external link)...

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123Herbals LLC (123Herbals.com) Issues Voluntary Nationwide Recall of Vail-Bon Jie Yang Wan Capsules Due to the Presence of Undeclared Dexamethasone and Chlorpheniramine

Rosemead, CA, 123herbals is voluntarily recalling all lots of Vail-Bon Jie Yang Wan capsules to the consumer level. The product has been found to be tainted with the drug ingredients, dexamethasone and chlorpheniramine. Vail Bon Jie Yang Wan capsules is an unapproved new drug for which the safety an Read More (external link)...

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Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination

September 17, 2024 – Princeton, NJ, Bionpharma Inc. is voluntarily recalling (1) single Batch (2310083) of Atovaquone Oral Suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc. in Clearwater, FL and distributed by Bionpharma Inc. The product was found to be con Read More (external link)...

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Infusion Pump Correction: B. Braun Medical Inc. Issues Correction for lnfusomat Space Infusion System/Large Volume Pump, in addition to Infusomat Space Large Volume Pump Wireless, and lnfusomat Space Large Volume Pump Non-Wireless BATTERY PACK, Due to Faulty Occlusion Alarm 

Infusomat Space Infusion Systems deliver fluids, blood, and blood products. The occlusion alarm may sound when there is no occlusion, leading to delayed therapy. Read More (external link)...

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FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause. Stop Medicine if Signs and Symptoms of Liver Injury Occur – Drug Safety Communication

The FDA is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury. Read More (external link)...

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