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    Aurobindo Pharma USA recalls heartburn drug Ranitidine over cancer causing impurities

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-11-10T09:45:12+05:30  |  Updated On 16 Aug 2021 5:10 AM GMT

    Aurobindo Pharma is second city-based drug company that has initiated the voluntary recall after the FDA announced an investigation into the reported carcinogenic impurity in the drug at low levels.


    Hyderabad: Aurobindo Pharma USA, Inc. is conducting a voluntary recall of Ranitidine tablets 150 mg Ranitidine capsules 150mg, 300 mg and syrup due to the detection of carcinogenic impurities, the company informed the USA Food and Drug Administration.


    This is the second city-based drug company that has initiated the voluntary recall after the FDA announced an investigation into the reported carcinogenic impurity in the drug at low levels.


    Earlier, Dr Reddys Laboratories had said it initiated the recall of Ranitidine due to suspected impurities.


    It said it suspended worldwide supplies of the drug owing to the FDA investigation.


    "To date, Aurobindo Pharma USA, Inc. has not received any report of adverse events related to this recall," Aurobindo said in a letter to the US regulator.


    NDMA (nitrosodimethylamine) 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.


    Read Also: Aurobindo Pharma gets 8 USFDA observations for 2 facilities in Hyderabad


    Ranitidine is used to decrease the amount of acid created by the stomach and relieves heartburn associated with acid indigestion and sore stomach.


    The FDA, in a statement issued on September 13, had said it is working with international regulators and industry partners to determine the source of this impurity in Ranitidine and examining levels of NDMA in Ranitidine and evaluating any possible risk to patients.


    Read Also: Aurobindo Pharma wins USFDA nod for a generic version of Mucinex Tablets

    Aurobindo Pharma cancer carcinogenic impurities Dr Reddy's Laboratories Dr Reddy's Labs IARC International Agency for Research on Cancer NDMA Nitrosodimethylamine pharma ranitidine recall USFDA 
    Source : PTI

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    Medical Dialogues Bureau
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      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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