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  • First Human Case of West Nile Viral Disease in NYC in 2016

    Monday, September 12, 2016

    West Nile viral activity continues to increase in New York City in mosquitoes. The first human case of West Nile viral disease was identified in a Brooklyn man. West Nile virus positive mosquito pools have been identified in all five boroughs.

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  • FDA MedWatch: Recall of six batches of GlucaGen® HypoKit®

    Friday, September 9, 2016

    Novo Nordisk Inc. is recalling six batches of the GlucaGen® HypoKit® in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile Water for Injection (SWFI).

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  • New CMS Emergency Preparedness Rules

    Thursday, September 8, 2016

    The Centers for Medicare & Medicaid Services (CMS) finalized rules to establish consistent emergency preparedness requirements for healthcare providers participating in Medicare and Medicaid, increase patient safety during emergencies, and establish a more coordinated response to natural and man-made disasters. These new rules will require certain participating providers and suppliers to plan for disasters and coordinate with federal, state, tribal, regional, and local emergency preparedness systems to ensure that facilities are adequately prepared to meet the needs of their patients during disasters and emergency situations. The effective date will be November 16, 2016 and the implementation date will be November 16, 2017.

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  • FDA MedWatch: VASCU-GUARD Peripheral Vascular Patch by Baxter

    Thursday, September 1, 2016

    The FDA has recently received multiple adverse event reports associated with Baxter International Inc.’s Vascu-Guard Peripheral Vascular Patch (also referred to as the Vascu- Guard patch) during carotid endarterectomy (CEA). These reports from 2016 include intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention, and three patient deaths potentially related to this issue that occurred shortly after CEA surgery. The device manufacturer, Baxter International, Inc., alerted the FDA to these adverse events.

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  • FDA MedWatch: Eyesaline Eyewash by Honeywell - Recall

    Monday, August 22, 2016

    Honeywell is voluntarily recalling one production lot of 32-ounce bottles of Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury. Although no injuries have been reported and no contamination was found in batch testing, there is a risk of product contamination with Klebsiella pneumoniae.

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  • FDA MedWatch: Oxacillin for Injection, USP, 10g by Sagent - Recall

    Friday, August 19, 2016

    Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017) manufactured by Astral SteriTech Private Limited and distributed by Sagent. Sagent initiated this recall to the user level due to the receipt of a product complaint for a single vial containing small, dark particulate matter found within the solution after reconstitution. The particulate matter has been identified as iron oxide.

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  • Newly Released Treatment of Drug-Susceptible Tuberculosis (TB) Guidelines

    Thursday, August 18, 2016

    Although tuberculosis (TB) is no longer a leading cause of death in the United States, efforts to eliminate this potentially fatal disease are critical. After two decades of steady decline, the number of reported U.S. TB cases rose slightly in 2015 to 9,563, according to provisional data released by CDC.

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  • AKF Press Release: Disaster Relief Program Activated to Help Kidney Patients Affected by Floods in LA and MS

    Wednesday, August 17, 2016

    The American Kidney Fund (AKF), the nation’s leading provider of charitable assistance to people with kidney failure, has activated its Disaster Relief Program to help dialysis patients affected by the devastating flooding in Louisiana and Mississippi.

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  • FDA:MedWatch - July 2016 Safety Labeling Changes

    Monday, August 15, 2016

    The MedWatch July 2016 Safety Labeling Changes posting includes 52 products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE.

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  • FDA Company Announcement: PharmaTech LLC Issues Voluntary Nationwide Recall

    Monday, August 8, 2016

    PharmaTech, LLC of Davie, FL, is voluntarily recalling all liquid products from October 20, 2015 through July 15, 2016 as a precautionary measure due to a potential risk of product contamination with Burkholderia cepacia.

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