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HSAG ESRD Alerts, Recalls, and Notices

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  • Becton Dickinson (BD) Recalls Alaris Infusion Sets for the Alaris Pump Model 8100

    Saturday, July 20, 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

    • Alaris Pump Model 8100 Infusion Sets
    • Lot Numbers: See full list of affected devices in BD recall notice
    • Manufacturing Dates: May 1, 2016 to March 31, 2019
    • Distribution Dates: July 1, 2016 to April 18, 2019
    • Devices Recalled in the U.S.: 151,139,816
    • Date Initiated by Firm: May 6, 2019


    Device Use

    Becton Dickinson (BD) Alaris Infusion Sets are used with an infusion pump to deliver fluids including medications, blood, or blood products, into a patient's body in a controlled manner. The pump administers fluid via an infusion tubing set into a patient's vein or through other cleared routes of administration. The sets are comprised with components commonly found on intravascular administration sets and extension sets. The components include an Alaris Pump module silicone segment and fitments, drip chamber, check valve, one or more SmartSite needleless connectors, slide clamp, male Luer with spin lock, and tubing of different lengths. These infusion sets are intended to be used with the BD Alaris Pump Module 8100. The devices are used in hospitals and other health care facilities.

    Reason for Recall

    Becton Dickinson (BD) is recalling Alaris Infusion Sets, due to the potential for faster than expected delivery of medication (over-infusion) or an unintended delivery that occurs while the pump is not in a "running status." The firm has determined that the silicone segment of the affected administration set has non-uniform thickness. Non-uniform wall thickness can lead to non-uniform tubing collapse and can contribute to a failure to fully occlude the tubing. This device defect may cause serious adverse health consequences for patients, including death. This recall has been associated with MDR reports, several of which are associated with serious injuries.

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  • Voluntary Recall: Baxter REVACLEAR 400 Dialyzer

    Monday, July 8, 2019

    The FDA has announced a Class II recall of three lots of the Baxter Revaclear 400 Dialyzer, Product Code 114746L.

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  • Voluntary Recall: Baxter REVACLEAR 300 Dialyzer

    Monday, July 8, 2019

    The FDA has announced a Class II recall of 59 lots of the Baxter Revaclear 300 Dialyzer, Product Code 114745L. These HD dialyzers may leak blood during dialysis because there is potential for fibers in the dialyzer to rupture.

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  • Certain Medtronic MiniMed Insulin Pumps Have Potential Cybersecurity Risks: FDA Safety Communication

    Monday, July 1, 2019

    The FDA is warning patients and health care providers that certain Medtronic MiniMed™ insulin pumps have potential cybersecurity risks. Patients with diabetes using these models should switch their insulin pump to models that are better equipped to protect against these potential risks.

    Medtronic is recalling the following affected MiniMed pumps and providing alternative insulin pumps to patients.

    Pump Model                                                 Software Version
    MiniMed™ 508                                                  All versions
    MiniMed™ Paradigm™ 511                              All versions
    MiniMed™ Paradigm™ 512/712                       All versions
    MiniMed™ Paradigm™ 515/715                       All versions
    MiniMed™ Paradigm™ 522/722                       All versions
    MiniMed™ Paradigm™ 522K/722K                  All versions
    MiniMed™ Paradigm™ 523/723                       Version 2.4A or lower
    MiniMed™ Paradigm™ 523K/723K                  Version 2.4A or lower
    MiniMed™ Paradigm™ 712E*                          All versions
    MiniMed™ Paradigm™ Veo 554CM/754CM*   Version 2.7A or lower
    MiniMed™ Paradigm™ Veo 554/754*              Version 2.6A or lower

    * Available outside the United States only.

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  • Macleods Pharmaceutical Limited Issues Voluntary Nationwide Consumer Level Recall of Losartan Potassium 50mg and Losartan Potassium/Hydrochlorothiazide combination Tablets

    Thursday, June 27, 2019

    Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the patient level, of 32 lots of Losartan Potassium USP Tablets (2 lots of 50mg strength) and Losartan Potassium/Hydrochlorothiazide combination Tablets (12 lots  of  50mg/12.5mg strength, 3 lots of 100mg/12.5mg strength and 15 100mg/25mg strength) to the patient level due to the detection of trace amounts of an unexpected impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The impurity was found in 32 lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration's interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out.

    Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Patients who are on Losartan Potassium Tablets and Losartan Potassium/Hydrochlorothiazide combination Tablets, USP should continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

    To date, Macleods Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

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  • Teva Pharmaceuticals USA, Inc. Expands Voluntary Nationwide Recall of Losartan Potassium

    Thursday, June 13, 2019

    Teva Pharmaceuticals USA, Inc. has expanded its voluntary consumer-level recall originally initiated on April 25, 2019 in the United States of losartan potassium tablets. This expanded recall includes six (6) lots of bulk losartan potassium USP Tablets (two lots of 50 mg strength and four lots of 100 mg strength) due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. The source of the NMBA impurity was detected in one lot of active pharmaceutical ingredient (API), manufactured by Hetero Labs Limited, which was used in the manufacturing of the six (6) bulk lots of these drug products. Based on the available information, there is a potential risk of developing cancer in a few patients following long-term use of products containing high levels of NMBA.

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  • Heritage Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Amikacin Sulfate Injection

    Monday, June 10, 2019

    Heritage Pharmaceuticals Inc. (“Heritage”) East Brunswick, New Jersey, is initiating a voluntary recall of Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), Lot: VEAC025, Expiry Date: October 2019 and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), Lot: VPCA172, Expiry Date: April 2020, to the consumer level. These drug products are manufactured by Emcure Pharmaceuticals Ltd. (“Emcure”) and distributed by Heritage. The voluntary recall is being initiated due to microbial growth having been detected in one unreleased sublot of Lot VPCA172 and one unreleased sublot Lot VEAC025, which may indicate a lack of sterility in the other sublots.

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  • Nationwide Shortage of Tuberculin Skin Test Antigens

    Friday, June 7, 2019

    The Centers for Disease Control and Prevention (CDC) is expecting a 3 to 10 month nationwide shortage of APLISOL®, a product of Par Pharmaceuticals. APLISOL® is one of two purified-protein derivative (PPD) tuberculin antigens that are licensed by the United States Food and Drug Administration (FDA) for use in performing tuberculin skin tests. The manufacturer notified CDC that they anticipate a supply interruption of APLISOL® 5 mL (50 tests) beginning in June 2019, followed by a supply interruption of APLISOL® 1 mL (10 tests) in November 2019. The expected shortage of APLISOL® 1 mL (10 tests) could occur before November 2019, if demand increases before then. The 3-10 month timeframe for the nationwide shortage is the manufacturer’s current estimate and is subject to change.

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  • FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the U.S.

    Tuesday, May 21, 2019

    The U.S. Food and Drug Administration (FDA) is warning health care providers and people with diabetes of risks associated with use of devices for diabetes management unauthorized for sale in the U.S., whether used alone or along with other devices. These unauthorized diabetes management devices have not been reviewed by the FDA to ensure they provide a reasonable assurance of safety and effectiveness for their intended use. Use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention or death.

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  • Novartis Issues Voluntary Nationwide Recall of Promacta┬« 12.5 mg for Oral Suspension Due to Potential Peanut Contamination

    Monday, May 13, 2019

    Novartis has announced a voluntary recall of three lots of Promacta (eltrombopag) 12.5 mg for oral suspension to the consumer level. The oral suspension lots are being recalled because of a risk of potential peanut flour contamination that occurred at a third-party contract manufacturing site.

    Promacta tablets in 12.5 mg, 25 mg, 50 mg and 75 mg strengths are not impacted by this recall and are not manufactured in the same facility.

    Peanut is a known food allergen. Potential cross contamination with peanut flour, even in small traces, can lead to hypersensitivity reaction in a population of patients with an unknown or known sensitivity to peanut antigen, including a medically significant anaphylactic reaction, which can be fatal.

    To date, Novartis has not received any reports or adverse events for this recall.

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