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Early Alert: Extracorporeal Blood Circuit Issue from Nuwellis
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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FDA Roundup: December 27, 2024
FDA Roundup: December 27, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-27-2024
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FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
http://www.fda.gov/news-events/press-announcements/fda-proposes-rule-require-standardized-testing-methods-detecting-and-identifying-asbestos-talc
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Astellas Pharma US, Inc. Issues Voluntary Nationwide Recall of One Lot of PROGRAF® 0.5mg (Tacrolimus) and One Lot of ASTAGRAF XL® 0.5mg (Tacrolimus Extended-Release Capsules) Because Bottles Shipped to U.S. May Contain Empty Capsules
Astellas Pharma US, Inc. (Head of US Commercial: Michael Petroutsas, “Astellas”) is voluntarily recalling one lot of PROGRAF® 0.5mg (tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (tacrolimus extended-release) capsules to the consumer level. These products are being recalled because bottles may conta
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FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes
FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes
http://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-once-daily-glp-1-injection-lower-blood-sugar-patients-type-2-diabetes
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Alcon Laboratories Issues Voluntary Nationwide Recall of One (1) Lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101), Due to Fungal Contamination
Fort Worth, Texas. Alcon Laboratories is voluntarily recalling one (1) lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) to the consumer level. Alcon evaluated a consumer complaint of foreign material observed inside a sealed single use vial and determined th
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Early Alert: Endoscope Accessories Forceps/Irrigation Plug Issue from Olympus
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program
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FDA Approves First Medication for Obstructive Sleep Apnea
FDA Approves First Medication for Obstructive Sleep Apnea
http://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea
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FDA Roundup: December 20, 2024
FDA Roundup: December 20, 2024
http://www.fda.gov/news-events/press-announcements/fda-roundup-december-20-2024
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FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities
FDA Approves First Acellular Tissue Engineered Vessel to Treat Vascular Trauma in Extremities
http://www.fda.gov/news-events/press-announcements/fda-approves-first-acellular-tissue-engineered-vessel-treat-vascular-trauma-extremities
