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    • Dr Reddys, Cipla arm...

    Dr Reddys, Cipla arm recall drugs in US; includes 7.8 lakh vials of Testosterone Cypionate injection

    Farhat NasimWritten by Farhat Nasim Published On 2019-04-29T09:45:31+05:30  |  Updated On 29 April 2019 9:45 AM IST
    Dr Reddys, Cipla arm recall drugs in US; includes 7.8 lakh vials of Testosterone Cypionate injection

    Besides, InvaGen Pharmaceuticals Inc, a subsidiary of Mumbai-based drug maker Cipla, is recalling over 7.8 lakh vials of Testosterone Cypionate injection, used to treat low testosterone levels in men.


    New Delhi: Drug major Dr Reddy's Laboratories is recalling 33,958 bottles of Divalproex Sodium Extended-Release tablets, used to treat seizure disorders, from the American market, as per a report by the US health regulator.


    Besides, InvaGen Pharmaceuticals Inc, a subsidiary of Mumbai-based drug maker Cipla, is recalling over 7.8 lakh vials of Testosterone Cypionate injection, used to treat low testosterone levels in men.


    Read Also: After 11 years, Dr Reddys Lab gets Chinese regulator nod for generic Clopidogrel


    Dr Reddy's Laboratories Inc, a subsidiary of the Hyderabad-based Dr Reddy's Laboratories, is voluntarily recalling the affected lot of bottles on account of certain deviations from the Current Good Manufacturing Practice (CGMP) regulations.


    As per the latest enforcement report by the US Food and Drug Administration (USFDA), the firm is recalling the product as it has been exposed to above 50 per cent relative humidity levels during packaging operations.


    The product was supplied to major distributors and retailers who may have further distributed the product throughout the US, the report added.


    Read Also: Dr Reddy’s expands injectable portfolio with the acquisition of 42 ANDAs in US


    Meanwhile, InvaGen Pharmaceuticals Inc is recalling its product in various strengths due to the "presence of particulate matter", the report said.


    The vials were manufactured by Cipla at its Verna facility in Goa for Cipla USA Inc.


    The USFDA has classified both the recalls as a Class-II recall, which 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: Dr Reddy’s arm sells US rights for Sernivo, Promises, Trianex to Encore Dermatology

    cGMPCiplaCipla USA Inccurrent good manufacturing practiceDivalproex Sodium TabletsDr ReddyDr Reddy'sDr Reddy's LabsDrug major Dr Reddys Laboratoriesdrug maker CipladrugsInvagen pharmaceuticalsInvaGen Pharmaceuticals Inclow testosterone levelNew Delhiseizure disorderstestosteroneTestosterone Cypionate injectiontreatUS Food and Drug AdministrationUS healthUS marketUSFDA
    Source : PTI

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    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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