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  • Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Consumer Level Recall of 38 Lots of Ranitidine

    Friday, November 8, 2019
    Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 1 lot of Ranitidine Tablets 150mg to the retail level and 37 lots of Ranitidine Capsules 150mg, Ranitidine Capsules 300mg and Ranitidine Syrup 15mg/mL to the consumer level due to the detection of NDMA (Nitrosodimethylamine) Impurity in...

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  • Medtronic Recalls MiniMed Insulin Pumps for Potential Cybersecurity Risks

    Wednesday, November 6, 2019
    Medtronic is recalling the specified insulin pumps due to potential cybersecurity risks. An unauthorized person (someone other than a patient, patient caregiver, or health care provider) could potentially record and replay the wireless communication between the remote and the MiniMed insulin pump....

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  • Lannett Issues Voluntary Nationwide Recall of Ranitidine Syrup

    Wednesday, October 30, 2019
    Lannett Company, Inc. today announced that it is voluntarily recalling all lots within expiry of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL to the consumer level due to levels of N-Nitrosodimethylamine (NDMA) above the levels recently established by the FDA for Ranitidine...

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  • Mylan Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets

    Tuesday, October 29, 2019
    Mylan Pharmaceuticals Inc. is conducting a voluntary nationwide recall of one lot (see table below) of Alprazolam Tablets, USP C-IV 0.5 mg, to the consumer/user level. This lot is being recalled due to the potential presence of foreign substance. Clinical impact from the foreign material, if...

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  • Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules

    Friday, October 25, 2019
    Novitium Pharma LLC (Novitium) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules in the US to the consumer level. Ranitidine Hydrochloride Capsules are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels...

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  • Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S.

    Wednesday, October 23, 2019
    As a precautionary measure, Sanofi on Friday, October 18, intiated a voluntary recall of all Zantac OTC (over-the-counter) in the United States. This includes Zantac 150®, Zantac 150® Cool Mint, and Zantac 75®. Zantac tablets are an oral, over-the-counter product to prevent and relieve...

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  • Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market

    Wednesday, October 23, 2019
    Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries, together referred to as “Dr. Reddy’s”) confirms it had intiatiated a voluntary nationwide recall on October 1, 2019, (at the retail level for over-the-counter products and at...

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  • Medtronic Recalls 6 French Sherpa NX Active Guide Catheters Due to Separation and Fragmentation Issue

    Thursday, October 10, 2019

    Medtronic is recalling the 6 French Sherpa NX Active Guide Catheter due to a risk of the outer material separating from the device resulting in detached fragments that could result in the underlying stainless-steel braid wires being exposed. These fragments could be left inside the patient’s bloodstream, and this or the attempts made to retrieve the fractured pieces, can cause other serious adverse health consequences such as continued blockage of blood vessels, injury to blood vessel walls, development of blood clots, embolism, heart attack or death.

    Medtronic received five customer complaints. No serious injuries or deaths were reported.

    Please note, this issue does not affect the Medtronic Launcher Coronary Guide Catheter or other Medtronic coronary stents, balloons or implantable devices.

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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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