Blog – PRAIS 2.0

FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine

Murilo Freitas - 14:01, 14 de July de 20257

FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine
http://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-products-containing-7-hydroxymitragynine

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Immunization in the Americas shows progress, but over 1.4 million children missed routine vaccines in 2024

admin - 12:00, 14 de July de 20256

Immunization in the Americas shows progress, but over 1.4 million children missed routine vaccines in 2024

Cristina Mitchell

15 Jul 2025

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Safety and Availability Concerns with VasoView HemoPro Endoscopic Vessel Harvesting Systems – Letter to Health Care Providers

Murilo Freitas - 04:00, 14 de July de 2025210

The FDA is alerting health care providers to the recall of certain VasoView HemoPro devices due to risk of silicone detachment during use, and supply concerns.

http://www.fda.gov/medical-devices/letters-health-care-providers/safety-and-availability-concerns-vasoview-hemopro-endoscopic-vessel-harvesting-systems-letter-health

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Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone Peeling or Detaching During Use

Murilo Freitas - 04:00, 14 de July de 2025277

HemoPro EVH Systems have updated instructions related to bent/detached heater wires and peeling/detaching silicone during minimally invasive surgery.

http://www.fda.gov/medical-devices/medical-device-recalls/endoscopic-vessel-harvesting-evh-system-correction-getinge-and-maquet-cardiovascular-update-use

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Early Alert: Infusion Set Performance Issue from BD

Murilo Freitas - 04:00, 14 de July de 20250

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-infusion-set-performance-issue-bd

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FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3

Murilo Freitas - 12:59, 13 de July de 202523

FDA Approves Gardenia (Genipin) Blue Color Additive While Encouraging Faster Phase-Out of FD&C Red No. 3

http://www.fda.gov/news-events/press-announcements/fda-approves-gardenia-genipin-blue-color-additive-while-encouraging-faster-phase-out-fdc-red-no-3

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Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry

Murilo Freitas - 04:00, 13 de July de 202524

Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfa

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nostrum-laboratories-inc-issues-voluntary-nationwide-recall-sucralfate-tablets-usp-1-gram-within

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A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: 100 Days of Embracing Gold-Standard Science, Transparency and Common Sense

Murilo Freitas - 15:03, 9 de July de 202556

A Statement from FDA Commissioner Marty Makary, M.D., M.P.H: 100 Days of Embracing Gold-Standard Science, Transparency and Common Sense
http://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-marty-makary-md-mph-100-days-embracing-gold-standard-science-transparency

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FDA Embraces Radical Transparency by Publishing Complete Response Letters

Murilo Freitas - 12:17, 9 de July de 202598

FDA Embraces Radical Transparency by Publishing Complete Response Letters
http://www.fda.gov/news-events/press-announcements/fda-embraces-radical-transparency-publishing-complete-response-letters

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Closed Suction Catheter Recall: Avanos Medical, Inc. Removes Ballard Closed Suction Systems Due to Risk of Non-Sterility

Murilo Freitas - 04:00, 9 de July de 202548

Select Ballard Closed Suction Systems lots may not be sterilized, increasing risk of infection, airway injury, prolonged inflammation, sepsis, or death if used.

http://www.fda.gov/medical-devices/medical-device-recalls/closed-suction-catheter-recall-avanos-medical-inc-removes-ballard-closed-suction-systems-due-risk