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2018

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  • Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication

    Friday, October 12, 2018

    The U.S. Food and Drug Administration (FDA) is issuing this safety communication to alert you that Medtronic is issuing a software update to address a safety risk caused by cybersecurity vulnerabilities associated with the internet connection between the Carelink 2090 and Carelink Encore 29901 Programmers used to download software from the Medtronic SDN. This update is a correction (voluntary recall) by the manufacturer to address the safety risk caused by the cybersecurity vulnerability.

    For the purposes of this safety communication, cybersecurity focuses on protecting patients' medical devices and their associated computers, networks, programs, and data from unintended or unauthorized threats.

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  • Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs

    Tuesday, September 11, 2018

    Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile.  These concerns arose following a routine inspection of the pharmacy by FDA.

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  • Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

    Thursday, August 30, 2018

    Accord Healthcare Inc. is voluntarily recalling One lot (Lot PW05264 – 46632 Bottles, NDC 16729-182-01) of Hydrochlorothiazide Tablets USP, 12.5 mg, to the consumer level.

    A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market. Based on findings of both preliminary and interim investigations carried out at the manufacturing site, Accord believes that no other lots of Hydrochlorothiazide Tablets are involved in this mix-up. Accord became aware of this finding through a product complaint reported from a pharmacy.

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  • SGLT2 Inhibitors for Diabetes: Rare Occurrences of a Serious Infection of the Genital Area

    Thursday, August 30, 2018

    FDA is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. We are requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide.

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  • Class 2 Device Recall AMIA Automated PD Cycler

    Tuesday, August 21, 2018

    Baxter Healthcare Corporation has issued a recall for the following power cords:

    • AMIA Automated PD Cycler, Product Code: 5C9320
    • Kaguya PD System, Product Code: T5C8500 

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  • Vyaire Medical, Inc. Recalls AirLife Resuscitation Devices Due to Manufacturing Error Preventing Oxygen Delivery

    Friday, August 10, 2018

    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(s): AirLife Resuscitation Devices
    • Product Codes: 2K8004, 2K8035C2, 2K8017, 2K8005, 2K8018, 2K8008, 2K8036, 2K8001, RE1DK5445D,2K8035M,2K8039,2K8004C2
    • Manufacturing Dates: February 5, 2018 to February 28, 2018
    • Distribution Dates: February 2, 2018 to April 20, 2018
    • Devices Recalled in the U.S.: 15,714 units nationwide

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  • FDA updates on valsartan recalls

    Friday, August 10, 2018

    Investigation ongoing – statement to be updated as more information is available

    FDA updates recalled valsartan-containing product information

    Update [8/9/2018] FDA has updated the list of valsartan products under recall and the list of valsartan products notunder recall to incorporate recalls of valsartan-containing products manufactured by Hetero Labs Limited, in India, labeled as Camber Pharmaceuticals Inc. Not all Camber valsartan products distributed in the U.S. are being recalled.

    Camber Pharmaceuticals is recalling certain valsartan tablets because they contain the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API). Hetero Labs manufactures the API for the Camber products using a process similar to Zhejiang Huahai Pharmaceuticals.

    Test results from Hetero Labs show the amount of NDMA found in its valsartan API exceeds acceptable levels; although it is generally lower than the amount discovered in the API manufactured by Zhejiang.

    FDA is testing samples of valsartan API and finished products to confirm the extent and amount of NDMA and help inform the ongoing investigation. The agency has also contacted other manufacturers of valsartan API to determine if their manufacturing processes are at risk for the formation of NDMA, and is working with them to ensure NDMA is not present in future valsartan API.

    Valsartan is an angiotensin II receptor blocker (ARB), and FDA is investigating whether other types of ARBs are at risk for the presence of NDMA.

    Recalled valsartan products labeled as Camber may be repackaged by other companies. FDA will provide updates as more information becomes available.

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  • Hepatitis Updates

    Friday, August 10, 2018

    The FDA recently approved revisions to the MAVYRET™ (glecaprevir and pibrentasvir) tablets label to include safety and efficacy data from the HCV/HIV-1 coinfection study (M14-730) and from the liver and renal transplant study (M13-596). A summary of the major revisions is provided.

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  • Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant

    Friday, August 3, 2018

    The antibiotic Zithromax, Zmax (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. We are reviewing additional data and will communicate our conclusions and recommendations when our review is complete.

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  • FDA updates on valsartan recalls

    Friday, August 3, 2018

    FDA updates recalled valsartan-containing product information and reminds API manufacturers to evaluate processes for unsafe impurities

    Update [8/2/2018] FDA continues to evaluate valsartan-containing products and has updated the list of products included in the recall and the list of products not included in the recall. In addition to updating the lists, FDA revised information related to A-S Medication on the list of products included in the recall. The agency will continue to provide information when it becomes available.

    FDA is working with drug manufacturers to ensure future valsartan active pharmaceutical ingredients (APIs) are not at risk of NDMA formation. The agency reminds manufacturers to thoroughly evaluate their API manufacturing processes, and changes to those processes, to detect any unsafe impurities. If a manufacturer detects new or higher levels of impurity, they should take action to prevent changes to the product’s safety profile. 

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