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    • Lupin, Glenmark recall...

    Lupin, Glenmark recall hypertension, fungal infection drugs from US market

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2019-08-26T09:45:25+05:30  |  Updated On 16 Aug 2021 5:12 PM IST

    New Delhi: Pharma major Glenmark is recalling over 31,000 tubes of anti-fungal Clotrimazole and Betamethasone Dipropionate cream from the US market, as per a report by the American health regulator. The company's US-based arm is recalling the lots.


    According to the latest Enforcement Report by the US Food and Drug Administration (USFDA), Glenmark Pharmaceuticals Inc USA is recalling 31,224 tubes of Clotrimazole and Betamethasone Dipropionate cream USP, 1 per cent/0.05 per cent, 15 gram tubes, manufactured by in Himachal Pradesh.


    The ongoing voluntary class III recall is on account of "Temperature Abuse: complaints received of liquidy texture," it added.


    The recall is nationwide within the United States, the USFDA said.


    Clotrimazole and Betamethasone Dipropionate Cream is used on the skin to treat fungal infections of the feet, genitals, inner thighs and buttocks, arms and legs and other body parts.


    As per USFDA, a class III recall is initiated in a situation "in which use of or exposure to a violative product is not likely to cause adverse health consequences".


    Lupin's arm, Lupin Pharmaceuticals Inc, is also recalling 39,216 bottles of Lisinopril and Hydrochlorothiazide tablets USP, 10 mg/12.5 mg, 100 tablet bottle manufactured at its Pithampur facility from the US market, the report said.


    The reason for the recall is "the presence of foreign substance; product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles," it added.


    The current voluntary class II recall is for the product that was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States, the report said.


    The tablets are used for the treatment of hypertension.


    As per USFDA, a class II recall is initiated in a situation, "in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote".


    Read Also: Glenmark gets USFDA nod for generic of Loestrin tablets to prevent pregnancy

    anti-fungalBetamethasone Dipropionate CreamClass 2 recallClass 3 recallClotrimazoleDrug Recallfungal infection drugGlenmarkhealth regulatorHydrochlorothiazidehypertension drugLisinoprilLupinnationwide drug recallpharmapharma companypharma newspharma news indiaPithampur facilityUS marketUSFDA
    Source : PTI

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    Medical Dialogues Bureau
    Medical Dialogues Bureau

      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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      Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription.Use of this site is subject to our terms of use, privacy policy, advertisement policy. You can check out disclaimers here. © 2025 Minerva Medical Treatment Pvt Ltd

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