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    • Dr Reddys recalls 2770...

    Dr Reddys recalls 2770 bags of Levetiracetam Sodium Chloride injection in US market

    Farhat NasimWritten by Farhat Nasim Published On 2019-02-22T11:53:40+05:30  |  Updated On 16 Aug 2021 11:21 AM IST

    As per the latest Enforcement Report of the US Food and Drug Administration (USFDA), Dr Reddys is recalling Levetiracetam in 0.54 per cent Sodium Chloride vaccination, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags.


    Hyderabad: Hyderabad based generic drugmaker with major exposure to U.S market, Dr Reddys is recalling 2770 bags of epilepsy drug in the US market, citing labelling error while 20,78,490 bottles of Esomeprazole Magnesium delayed-release capsules used in treating certain stomach and oesophagus problems.


    Dr Reddy's Laboratories is recalling 2,770 bags (277 selling units) of epilepsy drug Levetiracetam Sodium Chloride injection in the US market, on account of a labelling error.


    According to the latest Enforcement Report of the US Food and Drug Administration (USFDA), the drug firm is recalling Levetiracetam in 0.54 per cent Sodium Chloride vaccination, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags.


    Also Read: Dr Reddy's gets four observations from USFDA for Andhra plant


    The product is being recalled by Dr Reddy's US-based subsidiary and has been manufactured by Hyderabad-based Gland Pharma.


    The reason for recall is the pre-printed text on the primary infusion bag and the national drug code (NDC) incorrectly identifies the product as Levetiracetam in 0.75 per cent Sodium Chloride (1000 mg/100 mL), however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54 per cent Sodium Chloride injection (1,500/100 mL)."


    The ongoing voluntary nationwide recall has been classified as Class-I. Such recalls are for dangerous or defective products that predictably can cause serious health problems.


    Levetiracetam injection is an anti-epileptic drug indicated for adjunct therapy in adults on certain types of seizures when oral administration is temporarily not feasible.


    Dr Reddy's is also recalling 20,78,490 bottles of Esomeprazole Magnesium delayed-release capsules, used in treating certain stomach and oesophagus problems, in the US market.


    The US health regulator is yet to decide on the classification of the recall.


    Dr Reddy's Lab was founded by Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited, of Hyderabad.


    Dr Reddy's manufactures and markets a wide range of pharmaceuticals in India and overseas. The company has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology products.


    Also Read: Dr Reddys launches Tadalafil tablets for treating erectile dysfunction

    anti-epileptic drugBSEclass 1 recallDr reddy BSE filingDr Reddy'sDr Reddy's LabsDr Reddys Labepilepsy drugEsomeprazoleEsomeprazole MagnesiumGland Pharmaindian pharma newslabelling errorLevetiracetamnational drug codeoesophagus drug recallpharma newspharma news in indiaPharmaceuticalspre printingSodium Chloride injection
    Source : with inputs

    Disclaimer: This site is primarily intended for healthcare professionals. 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. © 2020 Minerva Medical Treatment Pvt Ltd

    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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