Murilo Freitas – Page 25

Early Alert: Nephroscope Sheath Issue from Trokamed GmbH

Murilo Freitas - 05:00, 19 de December de 2024166

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-nephroscope-sheath-issue-trokamed-gmbh

Endo USA, Inc. Issues Voluntary, Nationwide Recall of Adrenalin® Chloride Solution (EPINEPHrine Nasal Solution, USP) Due to the Potential for Administration Errors

Murilo Freitas - 05:00, 19 de December de 2024163

Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling all lots within expiry of Adrenalin® Chloride Solution (EPINEPHrine nasal solution, USP) 30mg/30mL (1mg/mL) 30 mL vials, to the consumer level. This product, which pre-d

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/endo-usa-inc-issues-voluntary-nationwide-recall-adrenalinr-chloride-solution-epinephrine-nasal

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FDA Updates “Healthy” Claim, Providing a Refreshed Tool for Consumers

Murilo Freitas - 16:39, 18 de December de 2024166

FDA Updates “Healthy” Claim, Providing a Refreshed Tool for Consumers
http://www.fda.gov/news-events/press-announcements/fda-updates-healthy-claim-providing-refreshed-tool-consumers

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FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease

Murilo Freitas - 21:40, 17 de December de 2024188

FDA Approves First Mesenchymal Stromal Cell Therapy to Treat Steroid-refractory Acute Graft-versus-host Disease
http://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host

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Catheter Correction: Boston Scientific Updates Use Instructions for POLARx and POLARx FIT Cryoablation Balloon Catheters due to Higher than Anticipated Number of Reports of Atrio-Esophageal Fistula

Murilo Freitas - 05:00, 17 de December de 2024193

POLARx Cryoablation Balloon Catheters treat atrial fibrillation. After reports of atrio-esophageal fistula, the use instructions are being updated.

http://www.fda.gov/medical-devices/medical-device-recalls/catheter-correction-boston-scientific-updates-use-instructions-polarx-and-polarx-fit-cryoablation

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Shoppers-Plaza Issues Voluntary Nationwide Recall of Fouzee Sugarlin Herbal Formula Due To Presence Of Undeclared Metformin And Glyburide

Murilo Freitas - 05:00, 17 de December de 2024226

December 16, 2024 – Los Angeles, California – Shoppers-Plaza is voluntarily recalling all lots of Fouzee Sugarlin Herbal Formula capsules to the consumer level. See Attachment 1 for photo of product labeling. Fouzee Sugarlin Herbal Formula capsules is an unapproved new drug for which safety and effi

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/shoppers-plaza-issues-voluntary-nationwide-recall-fouzee-sugarlin-herbal-formula-due-presence

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