FDA News

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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Innovation Bakers, LLC Issues Allergy Alert on Undeclared Walnut in 7-Eleven Fudge Brownie Distributed in Southern California

Innovation Bakers, LLC of Fullerton, CA, is issuing a voluntary limited recall of one day’s production of its 3.5 oz packs of 7-Eleven Fudge Brownie (05254856392) because they may contain undeclared walnuts. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life- Read More (external link)...

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