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Hologic, Inc. Recalls BioZorb Marker Due to Complications with Implanted Devices
Hologic, Inc. is recalling BioZorb Marker due to complications and adverse events with implanted devices.
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Implantable Marker Recall: Hologic Removes BioZorb 3D Bioabsorbable Markers due to Risk for Patient Complications
BioZorb Markers are implantable and used to mark soft tissue for procedures. They are being recalled after reports of patient complications.
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FDA Roundup: December 17, 2024
FDA Roundup: December 17, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-17-2024
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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.
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Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement – FDA Safety Communication
Read the FDA’s recommendations related to Accolade pacemaker devices by Boston Scientific and a potential need for early device replacement.
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FDA Approves New Treatment for Congenital Adrenal Hyperplasia
FDA Approves New Treatment for Congenital Adrenal Hyperplasia
http://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-congenital-adrenal-hyperplasia
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FDA Roundup: December 13, 2024
FDA Roundup: December 13, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-13-2024
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Buy-herbal.com Issues Voluntary Nationwide Recall of Nhan Sam Tuyet Lien Truy Phong Hoan Capsules Due to Undeclared Furosemide, Dexamethasone and Chlorpheniramine
12th December 2024, Flushing, New York, Buy-herbal.com is voluntarily recalling all lots within expiry of Nhan Sam Tuyet Lien Truy Phong Hoan Capsules to the consumer level. FDA analysis has found these products to contain undeclared Furosemide, Dexamethasone and Chlorpheniramine. Furosemide was fou
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Ocaliva (obeticholic acid) by Intercept Pharmaceuticals: Drug Safety Communication – Serious Liver Injury Being Observed in Patients without Cirrhosis
Based on its review of postmarket clinical trial data, the U.S. Food and Drug Administration (FDA) identified cases of serious liver injury among patients being treated for primary biliary cholangitis (PBC) with Ocaliva (obeticholic acid) who did not have cirrhosis of the liver.
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Early Alert: Infusion Pump Issue from Fresenius Kabi USA
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
