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HSAG ESRD Alerts, Recalls, and Notices

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  • Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse

    Monday, November 2, 2020
    Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 (see specific lots below) to the consumer level. This product may be contaminated with the bacteria Burkholderia lata.

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  • Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps

    Monday, November 2, 2020
    Baxter International Inc. announced today it has issued an Urgent Device Correction to reinforce important safety information regarding cleaning practices of all Spectrum infusion pumps distributed in the United States, Canada, and the Caribbean, as deviations from the specified cleaning methods...

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  • Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing

    Wednesday, October 14, 2020
    The U.S. Food and Drug Administration (FDA) recommends that health care providers give clear, step-by-step instructions to patients who, in a health care setting, are self-collecting anterior nares (nasal) samples for SARS-CoV-2 testing. Without proper instructions, patients may not collect an...

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  • Hurricane Delta—Clinical Guidance for Carbon Monoxide (CO) Poisoning

    Sunday, October 11, 2020
    The Centers for Disease Control and Prevention (CDC) is reminding healthcare professionals seeing patients from the areas affected by Hurricane Delta to maintain a high index of suspicion for carbon monoxide (CO) poisoning. Other people who may be exposed to the same CO source may need to be...

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  • Marksans Pharma Limited Issues Expansion of Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets

    Tuesday, October 6, 2020
    Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA)...

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  • Ashtel Studios Issues Voluntary Recall of Licensed Hand Sanitizers Packaged in 0.84 Fluid Ounce Pouches Due to Misbranding Because They Resemble Food and Drink Container Pouches

    Tuesday, October 6, 2020
    Ashtel Studios has announced a voluntary recall of all lots of licensed hand sanitizer packaged in .84 oz containers resembling food and drink pouches labeled with various children’s characters listed in the table below to the consumer level. The products are being recalled because they are...

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  • Recent HIV Clusters and Outbreaks Across the United States Among People Who Inject Drugs and Considerations During the COVID-19 Pandemic

    Tuesday, October 6, 2020
    Since 2015, the Centers for Disease Control and Prevention (CDC) and health departments across the United States have identified several HIV clusters and outbreaks occurring predominantly among people who inject drugs (PWID). Long-term declining trends in HIV incidence among people who inject drugs...

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  • Becton Dickinson CareFusion 303, Inc. Recalls Alaris™ System Pump Module and Pump Module Door Assembly Replacement Kits

    Monday, October 5, 2020
    BD/CareFusion 303 is recalling the BD Alaris Pump Module and Pump Module Door Assembly Replacement Kits because the keypad may have one or more keys that become unresponsive or stuck. This may lead to an infusion delay or prevent clinicians from changing fluid or medication infusions on the...

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  • Benadryl (diphenhydramine): Drug Safety Communication - Serious Problems with High Doses of the Allergy Medicine

    Friday, September 25, 2020
    FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death. FDA is aware of news reports of teenagers ending up in emergency rooms or dying after...

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  • Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use

    Friday, September 25, 2020
    The FDA is requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions...

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