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HSAG ESRD Alerts, Recalls, and Notices

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  • URGENT/11 Cybersecurity Vulnerabilities in a Widely-Used Third-Party Software Component May Introduce Risks During Use of Certain Medical Devices:

    Wednesday, October 2, 2019

    The U.S. Food and Drug Administration (FDA) is informing patients, health care providers and facility staff, and manufacturers about cybersecurity vulnerabilities that may introduce risks for certain medical devices and hospital networks. The FDA is not aware of any confirmed adverse events related to these vulnerabilities. However, software to exploit these vulnerabilities is already publicly available.

    A security firm has identified 11 vulnerabilities, named "URGENT/11." These vulnerabilities may allow anyone to remotely take control of the medical device and change its function, cause denial of service, or cause information leaks or logical flaws, which may prevent device function.

    These vulnerabilities exist in IPnet, a third-party software component that supports network communications between computers. Though the IPnet software may no longer be supported by the original software vendor, some manufacturers have a license that allows them to continue to use it without support. Therefore, the software may be incorporated into other software applications, equipment, and systems which may be used in a variety of medical and industrial devices that are still in use today.

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  • Apotex Corp. Issues Voluntary Nationwide Recall of Ranitidine Tablets 75mg and 150mg

    Monday, September 30, 2019

    Apotex Corp. is voluntarily, on a precautionary basis, recalling Ranitidine Tablets 75mg and 150mg (All pack sizes and Formats) to the Retail level. Apotex has learned from the U.S. Food and Drug Administration and other Global regulators that some ranitidine medicines including brand and generic formulations of ranitidine regardless of the manufacturer, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. To date, Apotex has not received any reports of adverse events related to use of the product.

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  • Sandoz Inc. Issues Voluntary Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg

    Friday, September 27, 2019

    Sandoz Inc. is voluntarily recalling all quantities and lots within expiryof Ranitidine Hydrochloride Capsules in the US to the consumer level because of confirmed contamination with N-Nitrosodimethylamine (NDMA) above levels established by the FDA in batches of Sandoz Ranitidine Hydrochloride Capsules. To date, Sandoz has not received any reports of adverse events related to use of the product as part of this recall.

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  • Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets

    Friday, September 27, 2019

    Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity while testing the below finished product batches manufactured utilizing active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited using the old Route of Synthesis. The recall is expanded to include an additional 3 lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP.

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  • New PZantac (ranitidine): Safety Information - NDMA Found in Samples of Some Ranitidine Medicinesage

    Tuesday, September 17, 2019
    The FDA has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based...

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  • Hospira Issues Voluntary Nationwide Recall for One Lot of BACTERIOSTATIC WATER

    Wednesday, September 11, 2019
    Hospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level. Hospira initiated this recall due to lack of confirmation of sterilization for some vials from this lot. In the event that impacted...

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  • Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension

    Tuesday, September 10, 2019
    Lawrence, KS, Plastikon Healthcare, LLC is voluntarily recalling Milk of Magnesia 2400 mg/30 mL Oral Suspension, lots 19027D and 19027E, to the patient level. Plastikon Healthcare initiated this recall because these product lots did not meet Plastikon’s in-house microbiological specification...

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  • The Metrix Company of Dubuque, Iowa is Recalling Specific Lots of the Empty IV Flexible Containers

    Tuesday, September 10, 2019
    The Metrix Company of Dubuque, Iowa is recalling specific lots of the empty IV flexible containers (bag) marketed under the Metrix Secure EVA Dual Chamber and Baxter ExactaMix names, due to the potential for leaking of the IV bag at the chamber divider rod, which could result in a serious infection...

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  • FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease

    Thursday, August 29, 2019
    Safety Announcement[08-28-2019] The Food and Drug Administration (FDA) has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. All...

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  • Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library

    Wednesday, August 14, 2019

    The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death.

    Recalled Product

    • Volumat MC Agilia Infusion System and Vigilant Drug Library
    • Models
      • Volumat MC Agilia Z021135, Software Versions 1.7 and 1.9a
      • Vigilant Drug Library Z073476, Software Versions 1.0 and 1.1
    • Lot Numbers: All
    • Manufacturing Dates: All
    • Distribution Dates: All
    • Devices Recalled in the U.S.:
      • Volumat MC Agilia - 9,461
      • Vigilant Drug Library - 83
    • Date Initiated by Firm: June 21, 2019

    Reason for Recall
    When enabled, the "Keep Vein Open (KVO), End of Infusion" alarm triggers when the infusion is complete. This results in the therapeutic rate of a medication changing to a non-therapeutic rate, as defined by the KVO rate. KVO alarms should be high priority. If a health care provider fails to respond to a "KVO, End of Infusion" alarm for a critical medication, a delay in care and/or under-infusion of medication can take place, which may lead to death or serious injury because the patient will be receiving a non-therapeutic rate of medication.

    Fresenius Kabi will change their  "Keep Vein Open (KVO), End of Infusion" alarm from a "low priority" to a "high priority" alarm to ensure the health care provider knows the infusion has completed.  There has been one death reported outside of the United States related to a norepinephrine infusion where a health care provider did not adjust the "Volume to be Infused" after changing the drug bag and then did not notice the pump's "low priority" "KVO, End of Infusion" alarm. No other injuries have been reported in the rest of the world or in the United States.

    Fresenius has also identified four software errors occurring with both the Volumat MC Agilia Infusion System and Vigilant Drug Library that may cause over-infusion or under-infusion of fluids/medications. These software errors could cause serious patient harm or death. There have been zero injuries and 14 complaints reported related to these software errors.  

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