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    • Drug Alert: CDSCO...

    Drug Alert: CDSCO declares 49 drug samples as Not of Standard Quality; Details

    Farhat NasimWritten by Farhat Nasim Published On 2020-01-14T14:32:36+05:30  |  Updated On 16 Aug 2021 4:31 PM IST
    Drug Alert: CDSCO declares 49 drug samples as Not of Standard Quality; Details

    New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) recently flagged 49 medicine batches for failing to qualify a random drug sample test for the month of December. These drug samples including Lorvas SR Tablets manufactured by Torrent Pharma, Udiliv 300 Tablets by Abbott and others are declared as 'Not of Standard Quality' while 1 out of the 47 drug samples has been declared as 'Spurious'.


    This came after analysis and test conducted by the CDSCO, Drugs Control Departments, on 1336 drug samples. Out of this, 1286 samples were found of Standard quality while 49 of them were declared as Not of Standard Quality (NSQ).


    Notable drugmakers including Torrent Pharma, Abbott, Akums Drugs and Pharmaceuticals Ltd., Zee Labs and others are involved in manufacturing the drugs.


    The drug samples tested failed due to the presence of Assay, Description, Particulate Matter & pH, Uniformity of Content & Dissolution, Dissolution, Related Substances, Description, pH, water content & Assay, Assay of Neomycin Sulphate, Polymixin-B Sulphate and others.


    The samples collected were tested in four laboratories namely CDTL Mumbai, RDTL Chandigarh, CDL Kolkata, RDTL Guwahati., CDL Chennai.


    List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the month of December 2019 reads;






































































































































































































































































































































































































    S.No. Name of Drugs/medical device/cosmetics Batch No./Date of Manufacture/Date of Expiry/Manufactured

    By
    Reason for failure Drawn By From
    1. Zobra Eye Ointment– 5g (Tobramycin Ophthalmic Ointment

    U.S.P. 0.3% w/w)
    B. No.: ZH17, Mfg date: 03/2019, Exp date: 02/2021,

    Mfd by: M/s. Selvok Pharmaceutical Co., 147, G.I.D.C., Antalia, Bilimora- 396321(Gujarat).
    Assay CDSCO,

    South Zone, Chennai
    CDL,

    Kolkata
    2. Diclofenac Sodium Injection I.P. B. No.: I-18165,

    Mfg date: 11/2018, Exp date: 10/2020,

    Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar 143 001 (India) Punjab.
    Description, Particulate Matter & pH , CDSCO,

    North Zone, Ghaziabad
    CDL,

    Kolkata
    3. Amoxycillin & Potassium Clavulanate Tablets I.P. 1000 mg B. No.: BT 180322,

    Mfg date: 05/2018, Exp date: 04/2020, Mfd by: M/s. Theon

    Pharmaceuticals Ltd., Village Saini Majra, Tehsil Nalagarh, Distt. Solan (H.P.).
    Uniformity of Content & Dissolution CDSCO,

    North Zone, Ghaziabad
    CDL,

    Kolkata
    4. Delisprin 75 (Aspirin Delayed-Release Tablets U.S.P. 75 mg) B. No.: M107M018,

    Mfg date: 12/2018, Exp date: 05/2020, Mfd by: M/s. Aristo

    Pharmaceuticals Pvt. Ltd., #Plot No. 208, New Industrial Area No.-2, Mandideep, Dist. Raisen (M.P.).
    Dissolution CDSCO,

    East Zone, Kolkata
    CDL,

    Kolkata
    5. Amlor - 2.5 (Amlodipine Besylate Tablets I.P.) B. No.: KN19001,

    Mfg date: 01/2019, Exp date: 12/2020, Mfd by: M/s. Ortin

    Laboratories Ltd., 275 & 278 (Part) I.D.A,

    Pashamilaram-502307, Sanga Reddy Dist, T.S., India. (Telangana).
    Related Substances CDSCO,

    East Zone, Kolkata
    CDL,

    Kolkata
    6. Enbilol (Nebivolol Hydrochloride Tablets

    I.P. 5 mg)
    B. No.: MT190877,

    Mfg date: 06/2019, Exp date: 05/2021, Mfd by: M/s. Mascot

    Health Series (P) Ltd., Plot No. 79, 80, Sec-6A,

    IIE, SIDCUL Haridwar- 249403 (Uttarakhand).
    Dissolution CDSCO,

    East Zone, Kolkata
    CDL,

    Kolkata
    7. Regunac-50 (Diclofenac Gastro Resistant Tablets I.P.

    50 mg)
    B. No.: FZ57B801,

    Mfg date: 02/2018, Exp date: 01/2021, Mfd by: M/s. Zim

    Laboratories Limited, B - 21/22, MIDC,

    Kalmeshwar – 441 501, District - Nagpur, Maharashtra.
    Description CDSCO,

    East Zone, Kolkata
    CDL,

    Kolkata
    8. CEFIXIME IP (COMPACTED) B. No.: CFEC190215,

    Mfg date: 06/2019, Exp date: 05/2022,

    Mfd by: M/s.Covalent Laboratories Pvt Ltd, Survey No. 374, Gundla Machnoor Village, Hathnoor Mandal,

    Sanga Reddy, (Dist)- 502296, Telangana.
    pH, water content & Assay CDSCO,

    Zonal Office, Hyderabad
    CDL,

    Chennai
    9. CLOXACILLIN CAPSULES IP 250 mg B. No.: MBC-18017,

    Mfg date: 04/2018, Exp date: 03/2020, Mfd by: M/s.Maxmed Lifesciences Pvt. Ltd, Plot No. 54, Sector IIDC, SIDCUL,

    Rudrapur (Uttarakhand).
    DESCRIPTION AND IDENTIFICATION CDSCO,

    South Zone Chennai
    CDL,

    Chennai
    10. Ursodeoxycholic Acid

    Tablets IP 300 mg ( UDILIV 300 TABLETS)
    B. No.: 010924D7,

    Mfg date: 01/2019, Exp date: 01/2021,

    Mfd by: M/s. Abbott India Limited, L 18/19, Verna Industrial Area, Verna, Salcette, Goa-

    403722.
    Identification Drugs

    Control Office
    RDTL,

    Chandigarh
    11. Dabigatran Etexilate Mesilate Capsules ( DABROUTE 110 MG CAPSULES) B. No.: SC-3115,

    Mfg date: 03/2019, Exp date: 02/2021, Mfd by: M/s. Sunvet Healthcare Village

    Shambhuwala, Nahan, Paonta Road, Distt.Sirmour (H.P).
    Assay CDSCO,

    Sub-Zone, Baddi, Himachal Pradesh.
    RDTL,

    Chandigarh
    12. Azithromycin Tablets IP (RZITH-250 TABLETS) B. No.: NT-18899,

    Mfg date: 02/2019, Exp date: 01/2021, Mfd by: M/s.

    H.L.Healthcare Pvt. Ltd. Plot No.25, Ind. Area, Phase-II, Gagret- 177201 (H.P.).
    Assay CDSCO,

    Sub-Zone, Baddi, Himachal Pradesh.
    RDTL,

    Chandigarh
    13. Indapamide SR Tablets 1.5 mg (LORVAS SR TABLETS) B. No.: CX23F011,

    Mfg date: 06/2019, Exp date: 05/2024,

    Mfd by: M/s. TORRENT PHARMACEUTICALS LTD. Baddi 173205,

    Dist.Solan (H.P), INDIA.


    Dissolution
    CDSCO,

    Sub-Zone, Baddi, Himachal Pradesh.
    RDTL,

    Chandigarh
    14. Domperidone Tablets IP 10 mg (DOMIDON- 10 TABLETS) B. No.: T-19066,

    Mfg date: 03/2019, Exp date: 02/2021,

    Mfd by: M/s. Jackson Laboratories Pvt. Ltd. 22-24, Majitha Road, Bye Pass, Amritsar- 143001 (Punjab) India.
    Identification A. CDSCO

    North Zone Ghaziabad
    RDTL,

    Chandigarh
    15. PRE AND PROBIOTIC CAPSULES-DS B. No.: UPPC-1808, Mfg date: 11/2018, Exp date: 04/2020,

    Mfd by: M/s. Heal (India) Laboratories Pvt. Ltd.

    No. 197/1,

    Periyapalayam Road, Manjankaranai-601102, Tamilnadu.
    Identification and Assay of Streptococcus faecalis T-110 JPC, Clostridium butyricum TO-A, Bacillus mesentericus TO- A JPC,

    Lactobacillus

    sporogenes.
    CDSCO

    North Zone, Ghaziabad
    RDTL,

    Chandigarh
    16. PRE AND PROBIOTIC CAPSULES-DS B. No.: UPPC-1907, Mfg date: 03/2019, Exp date: 08/2020,

    Mfd by: M/s. Heal (India) Laboratories Pvt. Ltd.

    No. 197/1,

    Periyapalayam Road, Manjankaranai-601102, Tamilnadu.
    Identification and Assay of Streptococcus faecalis T-110 JPC, Clostridium butyricum TO-A, Bacillus mesentericus TO- A JPC,

    Lactobacillus

    sporogenes.
    CDSCO

    North Zone Ghaziabad
    RDTL,

    Chandigarh
    17. ERYTHROMYCIN STEARATE TABLETS IP 250 MG B. No.: GPT004, Mfg date: 10/2018, Exp date: 09/2020,

    Mfd by: M/s. OMEGA PHARMA Khasra No. 482, Village Saliyar, Roorkee-247667, Distt. Haridwar, Uttrakhand.
    Dissolution CDSCO

    North Zone, Ghaziabad.
    RDTL,

    Chandigarh
    18. Calcitriol, Methylcobalamin, Folic Acid, Boron, Calcium Carbonate, Omega-3- Fatty Acids (EPA+DHA) Softgel Capsules ( 3G MAX SOFTGEL

    CAPSULES).
    B. No.: ALD9075A, Mfg date: 03/2019, Exp date: 02/2021, Mfd by: M/s. Amster

    Labs Vill. Saraj Majra Gujjran, Near Toll-Tax, Baddi-173205 (HP).
    Assay of Folic Acid. Drugs Control Office, H.P. RDTL,

    Chandigarh
    19. PANTOPRAZOLE SODIUM STERILE B. No.: APSS18004, Mfg date: 09/2018, Exp date: 08/2021,

    Mfd by: M/s. Rajasthan Antibiotics Limited, A- 619 & 630, Indl. Area. Bhiwadi-301019 (Rajasthan)-India
    Assay CDSCO,

    Sub-Zone, Baddi.
    RDTL,

    Chandigarh
    20. Fexofenadine Hydrochloride Tablets IP 180 mg (MEDROFEX-180 TABLETS) B. No.: SPT190012A,

    Mfg date: 01/2019, Exp date: 12/2020, Mfd by: M/s. SALUS

    PHARMACEUTICALS

    480/211, Harraipur, PO Gurumajra, Teh. Baddi, Distt. Solan (H.P.)- 173205.
    Dissolution CDSCO,

    Sub-Zone, Baddi.
    RDTL,

    Chandigarh
    21. NEOMYCIN SULPHATE, POLYMIXIN-B SULPHATE AND BACITRACIN ZINC POWDER B. No.: GLEP-181020,

    Mfg date: 10/2018, Exp date:,09/2020,

    Mfd by: M/s. Grampus Laboratories Johron, Industrial. Area, Kala Amb.Distt.Sirmour (H.P.). 173030.
    Assay of Neomycin Sulphate, Polymixin-B Sulphate. CDSCO

    North Zone, Ghaziabad
    RDTL,

    Chandigarh
    22. Lactulose Oral Solution USP (LACTOLOOK SOLUTION) B. No.: S-11366,

    Mfg date: 04/2019, Exp date: 03/2021, Mfd by: M/s. Montek

    Biopharma 45, Himuda Ind. Area Bhatolikalan, Baddi Dist. Solan (H.P.).
    Assay CDSCO

    North Zone, Ghaziabad
    RDTL,

    Chandigarh
    23. Ferrous Ascorbate, Folic Acid and Mecobalamin Suspension (FERIKIND-M SUSPENSION B. No.: A6APS006, Mfg date: 03/2019, Exp date: 08/2020, Mfd by: M/s. Akums Drugs &

    Pharmaceuticals Ltd. 22, Sector-6A, I.I.E.,

    SIDCUL, Haridwar- 249403 (Uttarakhand).
    Assay of Folic Acid CDSCO

    North Zone, Ghaziabad
    RDTL,

    Chandigarh
    24. Diclofenac Gel IP B. No.: 266,

    Mfg date: 01/2019, Exp date: 12/2020,

    Mfd by: M/s. Maxchem Pharmaceuticals (P) Ltd. Plot No.22, Sec-3, IIE, Pantnagar, Rudrapur, Distt. US

    Nagar-263153 (Uttarakhand).
    Related Substances CDSCO

    North Zone, Ghaziabad
    RDTL,

    Chandigarh
    25. Dried Aluminium Hydroxide, Magnesium Hydroxide and Simethicone Suspension ( DIZER MPS) B. No.: SL-383,

    Mfg date: 04/2019, Exp date: 03/2021,

    Mfd by: M/s. Sridhara Lifesciences Pvt.

    Ltd.Khasra No. 285, Sisona, Bhagwanpur,

    Roorkee, Distt. Haridwar (Uttarakhand).
    pH CDSCO,

    Sub-Zone, Baddi.
    RDTL,

    Chandigarh
    26. Isosorbide Mononitrate Tablets IP (ISO-10 TABLETS) B. No.: STN-181818,

    Mfg date: 03/2019, Exp date: 02/2021, Mfd by: M/s. Terrace Pharmaceuticals (P)

    Ltd. 3.B (a), Phase-III,

    Industrial Area, Sansarpur Terrace, Distt. Kangra (H.P)-

    176501.
    Description Drugs Control Office H.P. RDTL,

    Chandigarh
    27. Nitroglycerin Controlled-Release Tablets ( NITROMED- CR 2.6 TABLETS) B. No.: CRT-190409,

    Mfg date: 04/2019, Exp date: 03/2021, Mfd by: M/s. Civron Pharmaceuticals 13,

    Industrial Area, Phase- III, Sansarpur-Terrace, Distt. Kangra (H.P).
    Assay CDSCO,

    Sub-Zone, Baddi.
    RDTL,

    Chandigarh
    28. Nitroglycerin Controlled-Release Tablet (NITROMED- CR 6.4 TABLETS) B. No.: CRT-190618,

    Mfg date: 06/2019, Exp date: 05/2021, Mfd by: M/s. Civron Pharmaceuticals 13,

    Industrial Area, Phase- III, Sansarpur-Terrace, Distt. Kangra (H.P).
    Assay CDSCO,

    Sub-Zone, Baddi
    RDTL,

    Chandigarh
    29. Ciprofloxacin Tablets

    I.P. 500mg. (CIPJOHN-500)
    B. No.: HTN813D, Mfg date: 04/2018, Exp date: 03/2021,

    Mfd by: M/s. Himalaya Meditek Pvt. Ltd. Plot No. 35 & 36,

    Pharmacity, Selaqui, Industrial Area, Dehradun-248197

    (Uttarakhand).
    Dissolution Drugs Controller Department Arunachal Pradesh RDTL,

    Guwahati
    30. Cefadroxil Tablets I.P. 500mg. (Cedoxil-500) B. No.: T-16549,

    Mfg date: 03/2018, Exp date: 02/2020,

    Mfd by: M/s. Jackson Laboratories Pvt. Ltd., Bye Pass, Majitha Road, Amritsar-143004 (Punjab).
    Dissolution Drugs Controller Department Arunachal Pradesh RDTL,

    Guwahati
    31. Cefuroxime Axetil Tablets I.P. 500mg. (Amytum-500) B. No.: C903701T,

    Mfg date: 03/2019, Exp date: 02/2021, Mfd by: M/s. Nikvin

    Healthcare (I) Pvt. Ltd. Baddi, Barotiwala Road, Behind Govt. Timber Depot, Vill-Katha, H.P.- 173205.
    Dissolution Drugs Controller Department Tripura RDTL,

    Guwahati
    32. Zinc Sulphate

    Dispersible Tablets I.P.
    B. No.: ZN-S003, Mfg date: 04/2019,

    Exp date: 03/2021, Mfd by: M/s.Cyano

    Pharma (P) Ltd. 115-C,

    Indl. Estate, Plolo ground Indore-452015.
    Disintegration Drugs

    Controller Department Arunachal Pradesh
    RDTL, Guwahati
    33. Ondansetron Hydrochloride Tablets

    I.P. 4 mg. (Emigo 4)
    B. No.: ZLC1AQ8004, Mfg date: 08/2018,

    Exp date: 07/2021,

    Mfd by: M/s. Zuventus Healthcare Ltd., 5119, Oberoi Garden Estate, D-wing, Candivali, Andheri(E), Mumbai-

    400072.
    Dissolution Drugs Controller Department Meghalaya RDTL,

    Guwahati
    34. Calcium with Vitamin D3 Tablets B. No.: TAK8048AL, Mfg date: 04/2018, Exp date: 03/2020,

    Mfd by: M/s. Hindustan Laboratories Plot No. 5- 9, Survey No.-38/2, Aliyali, Palghar (W), Maharashtra-401404.
    Assay of Vitamin D3 Drugs Controller Department Assam RDTL,

    Guwahati
    35. Calcium with Vitamin D3 Tablets B. No.: TAK8162AL, Mfg date: 06/2018,

    Exp date: 05/2020,

    Mfd by: M/s. Hindustan Laboratories Plot No. 5- 9, Survey No.-38/2, Aliyali, Palghar (W),

    Maharashtra-401404.
    Assay of Vitamin D3 Drugs Controller Department Assam RDTL,

    Guwahati
    36. Calcium with Vitamin D3 Tablets B. No.: TAK8137AL, Mfg date: 06/2018, Exp date: 05/2020,

    Mfd by: M/s. Hindustan Laboratories Plot No. 5- 9, Survey No.- 38/2, Aliyali, Palghar (W), Maharashtra -401404.
    Assay of Vitamin D3 Drugs Controller Department Assam RDTL,

    Guwahati
    37. Azithromycin Tablets

    I.P. 500 mg (Zolid 500)
    B. No.: RAL-048, Mfg date: 06/2018, Exp date: 05/2020,

    Mfd by: M/s.Ronak Life Care Pvt. Ltd. R.S. No. 41 (Part) Vill- Rajpur, TA. & Dist- Patan - 384265, Ahmedabad.
    Dissolution Drugs Controller Department, Mizoram RDTL,

    Guwahati
    38. Rabeprazole Sodium Tablets I.P. (Rebz-20) B. No.: DVTE679B, Mfg date: 06/2018, Exp date: 05/2020,

    Mfd by: M/s. Digital Vision 176, Mauza Ogli Nahan Road, Kala-Amb, Dist-Sirmour, H.P. –

    173030.
    Dissolution Drugs Controller

    Department Assam
    RDTL,

    Guwahati
    39. Telmisartan Tablets

    I.P. 40 mg.
    B. No.: TMA1001, Mfg dt: 02/2019, Exp dt: 01/2021,

    Mfd by: M/s. Sai Mirra Innopharm Pvt. Ltd. 288 & 299, SIDCO Estate, Ambattur, Chennai- 600098.
    Dissolution Drugs Controller Department Arunachal Pradesh RDTL,

    Guwahati
    40. Paracetamol Tablets

    I.P. 500mg. (Asmol- 500)
    B. No.: T-18043,

    Mfg date: 05/2018, Exp date: 04/2020, Mfd by: M/s. Parth

    Orgichem Pvt. Ltd., Plot No.-G-365, M.G. Road,

    Industrial Area, Hapur (U.P).
    Dissolution Drugs Controller Department, Manipur RDTL,

    Guwahati
    41. Rebeprazole Sodium Tablets I.P. (YDZOLE 20) B. No.: TPT-0203,

    Mfg date: 10/2018, Exp date: 09/2020, Mfd by: M/s. Tanpal

    Pharmaceuticals D-12- 13, Focal Point Nabha- 147201 (Punjab).
    Dissolution Drugs Controller Department, Nagaland RDTL,

    Guwahati
    42. Nimesulide Tablets 100 mg B. No.: NP17016,

    Mfg date: 09/2017, Exp date: 08/2020,

    Mfd by: M/s. Navketan Pharma Pvt. Ltd. F-106, MIDC, Waluj, Aurangabad-431136 (Maharashtra).
    Disintegration Drugs Controller Department Arunachal Pradesh RDTL,

    Guwahati
    43. Etofylline & Theophylline Tablets IP B. No.: BN9002,

    Mfg date: 04/2019, Exp date:,03/2022,

    Mfd by: M/s. Halewood Laboratories Pvt. Ltd., 319, Phase-II, G.I.D.C.,

    Vatva, Ahmedabad.
    Disintegration CDSCO,

    South Zone, Chennai
    CDTL,

    Mumbai
    44. Acetaminophen 500 mg soft gelatin Capsules B. No.: M19AZ012,

    Mfg date: 06/2019, Exp date: 05/2021, Mfd by: M/s. Medgel Pvt. Ltd., 19 & 20,

    Special Economic Zone,

    Pharma Zone, Phase-II, Sector-III, Pithampur, Dist.-Dhar (M.P)-

    454775.
    Dissolution CDSCO,

    Sub Zone, Indore
    CDTL,

    Mumbai
    45. Montelukast Sudium & Levocetirizine Hydrochloride Tablets I.P. B. No.: 419-11B,

    Mfg date: 01/2018, Exp date: 12/2020, Mfd by: M/s. Zee

    Laboratories Limited, Behind 47, Industrial Area, Poanta Sahib-

    173025 (Punjab).
    Dissolution of Montelukast Sodium CDSCO,

    Sub Zone, Indore
    CDTL,

    Mumbai
    46. Norfloxacin Tablets IP 400 mg B. No.: T8422,

    Mfg date: 08/2018, Exp date: 07/2020, Mfd by: M/s. Zest

    Pharma, Plot No. 275, Sector F, Sanwer Road, Indore (M.P.) 452015.
    Dissolution CDSCO,

    Sub Zone, Indore
    CDTL,

    Mumbai
    47. Zinco (Zinc Sulphate Dispersible Tablets IP) B. No.: T-20152,

    Mfg date: 08/2019, Exp date: 07/2021,

    Mfd by: M/s. Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar- 143001.
    Disintegration CDSCO,

    West Zone, Mumbai
    CDTL,

    Mumbai

    Also Read: CDSCO declares 37 drug samples including Ibuprofen, Vitamin B-Complex as Not of Standard Quality

    Abbottakums drugcalcium tabletsCDSCOCedoxilCentral Drugs Standard Control OrganizationDrug alertdrug sample testlow quality drugsNorfloxacinParacetamolprobiotic capsulesSubstandard drugsTorrent PharmaVitamin D3 tablets

    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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