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  • FDA updates on angiotensin II receptor blocker (ARB) recalls including valsartan, losartan and irbesartan

    Monday, March 4, 2019

    Three new MedWatch Safety Alert recall medical products have been added to the FDA Recalls webpage. 

    • Losartan Potassium Tablets by Camber Pharmaceuticals: Recall—Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid Impurity found in the Active Pharmaceutical Ingredient (API)
    • Valsartan and Amlodipine and Valsartan Tablets by Aurobindo and Acetris: Recall—Due to the Detection of N-Nitroso N-Methyl 4-amino butyric acid Impurity found in the API

    FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall.

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  • Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators (IPGs) Due to Possible Circuit Error

    Friday, March 1, 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(s):

    • Medtronic, Inc. Dual Chamber Implantable Pulse Generators (IPGs)
    • Model Names:
      • Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, Q series
    • Manufacturing Dates: March 2, 2017, to December 18, 2018
    • Distribution Dates: March 6, 2017, to January 7, 2019
    • Devices Recalled in the U.S.: 13,440

    Device Use

    Medtronic’s Dual Chamber Implantable Pulse Generators (IPGs) are implanted cardiac pacemakers used to provide stimulation to increase heart rate in patients with a slow heart rhythm (bradycardia) or no heart rhythm. The pulse generator is the small implanted unit containing the battery and other electronic parts. The pulse generator must be used with insulated electrode wires called leads. These devices are designed to be used in addition to routine clinical monitoring by a health care professional.

    Reason for Recall

    Medtronic is recalling its dual chamber IPGs due to the possibility of a software error that can result in a lack of pacing. Patients and physicians cannot predict whether and when this software error might occur. A lack of pacing could result in patients experiencing slow heart beating, low blood pressure, and symptoms such as light headedness, fainting, and even death.

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  • Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Risk of Device "Lockup" (Freezing)

    Friday, March 1, 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(s)

    • Physio-Control, Inc. LIFEPAK15 Monitor/Defibrillator (LP15)
    • Model: LIFEPAK 15 Monitor/Defibrillators with Printed Circuit Board Assembly (PCBA) part no. 3206834-011 or 3206834-012
    • Serial/Lot Numbers:  See "Full List of Affected Devices"
    • Manufacturing Dates: March 21, 2013, to July 18, 2016
    • Distribution Dates: March 21, 2013, to July 18, 2016
    • Devices Recalled in the U.S.: 8,164

    Device Use

    Physio-Control's LIFEPAK 15 Monitor/Defibrillator is used to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Defibrillation electrodes are connected to the defibrillator to help the device analyze a patient's heart rhythm and deliver an electrical shock to restore normal heart rhythm when needed. The LIFEPAK 15 monitor displays the patient's heart rhythm so the health care provider can study the heart's electrical activity.

    The LIFEPAK 15 is designed to be used only by trained medical personnel during ground transport of a patient.

    Reason for Recall

    Physio-Control is recalling its LIFEPAK 15 Monitor/Defibrillator because the device may "lockup" (freeze) after a shock is delivered. When this occurs, the device's monitor display goes blank and there is no response from the keypad or the device although the device's LED lights remain on and indicates the device still has power.

    Once the LIFEPAK 15 freezes, it cannot provide defibrillation therapy until the device is reset by restarting the device or removing and reinserting all connected power sources. The resulting delay in delivering a shock could and has resulted in serious patient injury including death.

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  • Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide

    Friday, March 1, 2019

    Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

    Risk Statement: The impurity detected is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. Macleods is recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg that contains NDEA above the interim acceptable daily intake levels released by the FDA.

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

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

    The product subject to recall is listed below and packaged in bottles. The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.

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  • Terrific Care, LLC. / Medex Supply Dist, Inc. issues Nationwide Recall of CoaguChek Test Strips

    Thursday, December 27, 2018

    This announcement clarifies information included in Terrific Care, LLC's press release issued on 12/19/2018

    On 12/19/2018, Terrific Care, LLC. / Medex Supply Dist, Inc. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc. This recall only includes CoaguChek test strips distributed directly to U.S. consumers by Terrific Care, LLC. / Medex Supply Dist, Inc via its website/phone calls/facsimal of All Catalog/REF Numbers that DO NOT END IN 160.

    The products distributed by Terrific Care, LLC / Medex Supply Dist, Inc. have been found to inaccurately report high INR test results. Patients taking warfarin who receive inaccurate INR results above their target therapeutic range may be at risk for inappropriate therapeutic measures such as a warfarin dose reduction, interruption of warfarin use, or administration of vitamin K.

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  • Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

    Thursday, December 27, 2018

    FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta.  These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.  They can occur with fluoroquinolones for systemic use given by mouth or through an injection.

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  • Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP

    Thursday, December 27, 2018

    Torrent Pharmaceuticals Limited is voluntarily recalling 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

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  • Mylan Expands Its Voluntary Nationwide Recall

    Monday, December 10, 2018

    Mylan N.V. (NASDAQ: MYL) today (12/4/2018) announced that its U.S. based Mylan Pharmaceuticals business is expanding its consumer-level voluntary nationwide recall to include all lots of Valsartan-containing products within expiry. The 104 additional lots include 26 lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, 5mg/320mg and 10mg/320mg strengths), 51 lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg and 320 mg strengths), and 27 lots of Valsartan and Hydrochlorothiazide Tablets, USP (80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg strengths).

    Out of an abundance of caution, these products are being recalled due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Valsartan, USP, manufactured by Mylan Laboratories Limited. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according to the International Agency for Research on Cancer (IARC).

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  • Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall

    Friday, November 30, 2018

    Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes.

    Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets are used for the treatment of high blood pressure.

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  • Outbreak Alert Update: Potential Life-Threatening Vitamin K-Dependent Antagonist Coagulopathy Associated With Synthetic Cannabinoids Use

    Tuesday, November 27, 2018

    This COCA Clinical Action updates the message sent on April 5, 2018: https://content.govdelivery.com/accounts/USCDC/bulletins/1e6dac3

    Since the index case was identified on March 8, 2018 in Illinois, at least 160 people have presented to Healthcare facilities with serious unexplained bleeding. The preponderant number of patient presentations were in Illinois with other cases being reported from Florida, Indiana, Kentucky, Maryland, Missouri, Pennsylvania, Virginia, and Wisconsin. Laboratory investigation confirms brodifacoum exposure in at least 60 patients. There are at least 3 fatalities. At least 7 synthetic cannabinoids product samples related to this outbreak have tested positive for brodifacoum. At least one synthetic cannabinoids product has tested positive for both synthetic cannabinoid AB-FUBINACA and brodifacoum.

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