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  • Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death

    Thursday, November 16, 2017
    FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. FDA required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety...

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  • Midazolam Injection, USP, 2 mg/2 mL by Fresenius Kabi: Recall

    Monday, November 6, 2017
    Fresenius Kabi USA is voluntarily recalling Lot of Midazolam Injection, USP, 2 mg/2 mL packaged in a 2 mL prefilled single-use glass syringe to the hospital/user level. The product mislabeled as Midazolam Injection, USP, 2 mg/2 mL contains syringes containing and labeled as Ondansetron Injection,...

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  • Advice for Providers Treating Patients in or Recently Returned from Hurricane-Affected Areas, Including Puerto Rico and US Virgin Islands

    Wednesday, October 25, 2017
    The purpose of this HAN advisory is to remind clinicians assessing patients currently in or recently returned from hurricane-affected areas to be vigilant in looking for certain infectious diseases, including leptospirosis, dengue, hepatitis A, typhoid fever, vibriosis, and influenza. Additionally,...

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  • Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination

    Monday, October 23, 2017
    ISSUE: SCA Pharmaceuticals LLC (“SCA Pharmaceuticals”) is voluntarily recalling various lots of injectable products to the hospital level. The is a potential for the products to contain microbial contamination. See the recall notice for a full list of products.

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  • St. Jude Medical Recalls Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D)

    Friday, October 20, 2017
    St. Jude Medical Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. ICDs and CRT-Ds are both implanted under the...

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  • Intralipid 20 Percent IV Fat Emulsion by Baxter: Recall

    Saturday, October 7, 2017
    Baxter International Inc. announced today it is voluntarily recalling one shipment from a single lot of INTRALIPID 20% IV Fat Emulsion, 100 mL, distributed between 8/11/17 and 8/31/17 to hospitals and healthcare providers in the United States, to the user level. The product has been exposed to...

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  • Hurricanes Irma and Maria in the Caribbean Alert - Level 2, Practice Enhanced Precautions

    Tuesday, September 26, 2017
    Beginning on September 6, 2017, Hurricane Irma crossed the Caribbean, followed on September 16 by Hurricane Maria. The extent of destruction across these countries and territories varies, with many areas flooded and inaccessible. Significant damage from the hurricane has caused problems with water...

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  • Class 2 Device Recall Baxter Amia Automated Peritoneal Dialysis Set with Cassette

    Friday, September 22, 2017
    The firm (Baxter) initiated the recall by letter on 09/05/2017. The patients and clinics were directed to locate and remove all affected product and to contact Baxter Healthcare Center for Service to arrange for return and credit. The Baxter Healthcare Center for Service can be reached at...

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  • Ocaliva (obeticholic acid): Drug Safety Communication - Increased Risk of Serious Liver Injury

    Friday, September 22, 2017
    FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. These patients are receiving excessive dosing, particularly a...

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  • Guidance to All Providers Regarding Provision of Services During Hurricane Irma: This Guidance Applies for Both Fee-For-Service and Managed Care Providers

    Monday, September 18, 2017
    It is imperative Florida Medicaid recipients maintain access to services during the disaster period. To this end, the Agency will ensure reimbursement for services that are provided in good faith to eligible recipients...

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