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Date: 2017-07-05 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of June 2017

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

Gazette Notification Overview

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for the month of June 2017.
  • The list includes the name of the product, batch number, manufacturing and expiry dates, manufacturer details, reason for failure, and the name of the office that drew the sample.

Key Changes

  • Amlodipine Tablets IP (Lopin-5 Tablets), Batch No.: MNT-152913, manufactured by M/s. Terrace Pharmaceuticals (P) Ltd., failed due to related substances.
  • Calcium, Phosphorous, Magnesium, Zinc With Vitamin D3 Tablets (Calibon Tablets), Batch No.: 53055, manufactured by M/s. Swastik Formulations Pvt. Ltd., failed due to assay of vitamin D3.
  • Prednisolone Tablets IP 10 mg (Actaslone-10 Tablets), Batch No.: NHT-133, NHT-118 and Prednisolone Tablets IP 5 mg (Actaslone-5 Tablets), Batch No.: NHT-140, manufactured by M/s. Neutec Healthcare Pvt. Ltd., failed due to related substances and/or dissolution/assay of Prednisolone.
  • Ofloxacin and Ornidazole Tablets (OFSTAN-OZ Tablets), Batch No.: MT170442, manufactured by M/s. Medox Lifescience, failed due to assay of Ofloxacin and Ornidazole.
  • Cefixime, Dicloxacillin and Lactic Acid Bacillus Tablets (Cefiwok-XL 200 Tablets), Batch No.:WML6003, manufactured by M/s. Malik Lifesciences Pvt. Ltd., failed due to disintegration.
  • Paracetamol Tablets IP 650 mg (PACIPIK-650 Tablets), Batch No.:AA-246 , manufactured by M/s. AARPIK Pharmaceutical Pvt. Ltd., failed due to dissolution (Paracetamol).
  • Lactulose solution (Loozsun solution), Batch No.:STL-16468 , manufactured by M/s. Terrace Pharmaceuticals (P) Ltd., failed due to assay of Lactulose.
  • Germicide Gargle Povidone Iodine 1% W/V, Batch No.:EPM6001AL , manufactured by M/s. Hindustan Laboratories, failed due to assay of Povidone Iodine Calculated as Available Iodine.
  • Aciloc only (Ranitidine Oral Liquid), Batch No.:16010, manufactured by M/s. Cadila Pharmaceutical Limited, failed Test for Assay.
  • Rocap-20 (Piroxicam Capsules), Batch No.:298114 and 298113, manufactured by M/s. Lesanto Laboratories, failed Test for Water.
  • Kalcical-500 (Tablet of Vitamin D3 with Elemental Calcium), Batch No.:1508, manufactured by M/s. Vintochem Pharmaceuticals, failed Assay of Calcium & Vitamin D3.
  • Lecetzy (Levocetirizine Dihydrochloride Tablets I.P. 5 mg), Batch No.:416-136 , manufactured by M/s. Zee Laboratories Ltd., failed Test for Dissolution.
  • Thyrotop-100 (Thyroxine Sodium Tablets IP), Batch No.:TRHY0023, manufactured by M/s. Micro Labs Limited Unit-III, failed Assay.
  • Diethyl Carbamazine Citrate Tablets I.P. 50 mg, Batch No.:287, manufactured by M/s. Infinitive Pharmaceutical Industries, failed Description & Assay.
  • Gentamicin Sulphate Injection I.P. 2 ml, Batch No.:GS672, GS630 and GS651 , manufactured by M/s. Tamman Titoe Pharma Pvt. Ltd., failed Description & Particulate Matter.
  • Amikacin Sulphate Injection I.P. 100 mg - 2 ml, Batch No.:AK1663, manufactured by M/s. Nandani Medical Laboratories Pvt. Ltd., failed Description, Particulate Matter & Sterility.
  • Amitrust-250 (Amikacin Injection I.P.), Batch No.:ZCVAB17001, manufactured by M/s. Yeluri Formulation Pvt. Ltd., failed Description & Particulate Matter.
  • Absorbent Cotton Wool I.P., Batch No.:2489, manufactured by M/s. SJD Surgicot Pvt. Ltd., failed Surface-active Substances and water soluble substances.
  • Systocillin Injection (Oxytocin Injection I.P.-1), Batch No.:SY-1605, manufactured by M/s. Systochem Laboratories Ltd., failed Assay.
  • Tramajack (Tramadol HCl Injection), Batch No.: I-12259, manufactured by M/s. Jackson Laboratories Pvt. Ltd., failed Assay.
  • Forcecef 1gm (Ceftrixone Injection I.P.), Batch No.:10116054 , manufactured by M/s. Zeiss Pharmaceutical Pvt. Ltd., failed Particulate Matter.
  • DFZ-6 (Deflazacort Oral Suspension), Batch No.:HSL-836, manufactured by M/s. Himsagar Laboratories Limited, failed Assay.
  • Artcef-250 (Cefuroxime Axetil Tablets I.P.), Batch No.: DT-0199, manufactured by M/s. Ethix Healthcare, failed Dissolution.
  • Erythromycin Stearate Tablets I.P.500 mg, Batch No.: OB 04, manufactured by M/s. Gluconate Health Limited, failed Dissolution.
  • Absorbent Cotton Wool I.P., Batch No.:C4/12/14, manufactured by M/s. Shanti Surgicals Pvt. Ltd., failed Surface-active substances & Sulphated-Ash.
  • Vomidan-2 ml (Ondansetron Injection I.P.), Batch No.:67ONA181, manufactured by M/s. SPM Drugs (P) Ltd., failed Assay, Particulate Matter & Related Substances.
  • Paracetamol Tablets IP 500 mg, Batch No.: 2506714, manufactured by M/s. Karnataka Antibiotics & Pharmaceuticals Ltd., failed Dissolution.
  • Ferforte Tablets (Ferrous Ascorbate, Cyanocobalamin, Folic Acid with Zinc Tablets), Batch No.: CNL-026, manufactured by M/s. Coronet Labs Pvt. Ltd., failed Description.
  • Agni (Extra Strong Bleaching Powder), Batch No.: Nil, manufactured by M/s. Packed by: A.M. Enterprise, Guwahati, Assam, is Misbranded Drugs and failed Assay.
  • Bromol Plus Cough Expectorant, Batch No.: BT-169, manufactured by M/s. Angel Laboratories Pvt. Ltd., failed Assay.
  • Vominil Tablets, Batch No.:T-8304 , manufactured by M/s. Jackson Laboratories Pvt. Ltd, failed Dissolution.
  • Cadfen Tablets, Batch No.:CRT-150205, manufactured by M/s. Civron Pharmaceuticals, failed Uniformity of Weight and Assay.

Impact Analysis

Manufacturers

  • Action Item: Conduct a thorough internal investigation to identify the root cause of the quality failures and implement corrective and preventive actions (CAPA).

Consumers

  • Action Item: Healthcare providers should be informed to identify and manage patients who may have been affected by these substandard products. Issue a public advisory.

Distributors and Retailers

  • Action Item: Establish a system for promptly identifying and removing substandard products from the supply chain. Work with manufacturers on the recall process.

Regulatory Authorities

  • Action Item: Increase the frequency and rigor of inspections of manufacturing facilities. Enhance collaboration between central and state drug control authorities.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory authority for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratory, a laboratory that tests drugs for quality. CDL: Central Drugs Laboratory, the national statutory apex laboratory for quality control of drugs and pharmaceuticals in India. IP: Indian Pharmacopoeia
Official Source Record View Original Source →
See Full Document Text
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, For the Month of June, 2017 Sl. Name of Batch No./Date of Reason for Drawn By From No. Drugs/medical Manufacture/Date of failure device/cosmetics Expiry/Manufactured By 1. Amlodipine B. No.: MNT-152913 , Related CDSCO, RDTL, Tablets IP (Lopin-5 Mfg dt: 03/2016, Substances Sub- Zone, Chandigarh Tablets) Exp dt: 02/2018, Baddi Mfd by: M/s. Terrace Pharmaceuticals (P) Ltd., 3-B (a), Phase-III, Industrial Area, Sansar Terrace-176501. 2. Calcium, B. No.: 53055, Assay of CDSCO, RDTL, Phosphorous, Mfg dt: 07/2016, vitamin D3 Sub- Zone, Chandigarh Magnesium, Zinc Exp dt: 06/2018, Jammu With Vitamin D3 Mfd by: M/s. Swastik Tablets (Calibon Formulations Pvt. Ltd., G.T. Tablets) Road, Dulhipur, Chandauli- 232101. 3. Prednisolone B. No.: NHT-133, Related N.C.T. Delhi RDTL, Tablets IP 10 mg Mfg dt: 09/2014, Substances Chandigarh (Actaslone-10 Exp dt: 08/2017, Tablets) Mfd by: M/s. Neutec Healthcare Pvt. Ltd., E-698, DSIDC Narela Industrial Area, Delhi-110040. 4. Prednisolone B. No.: NHT-118, Related N.C.T. Delhi RDTL, Tablets IP 10 mg Mfg dt: 07/2014, Substances and Chandigarh (Actaslone-10 Exp dt: 06/2017, Dissolution Tablets) Mfd by: M/s. Neutec Healthcare (Prednisolone) Pvt. Ltd., E-698, DSIDC Narela Industrial Area, Delhi-110040. 5. Prednisolone B. No.: NHT-140, Related N.C.T. Delhi RDTL, Tablets IP 5 mg Mfg dt: 09/2014, Substances and Chandigarh (Actaslone-5 Exp dt: 08/2017, Assay of Tablets) Mfd by: M/s. Neutec Healthcare Prednisolone Pvt. Ltd., E-698, DSIDC Narela Industrial Area, Delhi-110040. 6. Ofloxacin and B. No.: MT170442, Assay of CDSCO, RDTL, Ornidazole Tablets Mfg dt: 04/2017, Ofloxacin and Sub-Zone, Chandigarh (OFSTAN-OZ Exp dt: 03/2019 Ornidazole Baddi Tablets) Mfd by: M/s. Medox Lifescience, Plot no. 222-223, Phase-III, Ind-Area, Sansarpur- Terrace (H.P). 7. Cefixime, B. No.:WML6003, Disintegration State Jammu RDTL, Dicloxacillin and Mfg dt: 03/2016, Chandigarh Lactic Acid Exp dt: 02/2018, Bacillus Tablets Mfd by: M/s. Malik Lifesciences (Cefiwok-XL 200 Pvt. Ltd., Plot No. 16, Vardhman Tablets) Indl. Estate, N.H. 58, Haridwar- 247667 (Uttarakhand). 8. Paracetamol B. No.:AA-246 , Dissolution CDSCO, RDTL, Tablets IP 650 mg Mfg dt: 02/2015, (Paracetamol) Sub-Zone, Chandigarh (PACIPIK-650 Exp dt: 01/2018, JammuTablets) Mfd by: M/s. AARPIK Pharmaceutical Pvt. Ltd., C1/306/5, Kerala G.I.D.C., Kerala Ta Bavla Road, Distt. Ahmedabad. 9. Lactulose solution B. No.:STL-16468 , Assay of CDSCO, RDTL, (Loozsun solution) Mfg dt: 01/2017, Lactulose Sub-Zone, Chandigarh Exp dt: 12/2018, Baddi Mfd by: M/s. Terrace Pharmaceuticals (P) Ltd., 3-B (a), Phase-III, Industrial Area, Sansarpur Terrace-176501. 10. Germicide Gargle B. No.:EPM6001AL , Assay of CDSCO, RDTL, Povidone Iodine Mfg dt: 06/2016, Povidone North Zone, Chandigarh 1% W/V Exp dt: 11/2017, Iodine Ghaziabad Mfd by: M/s. Hindustan Calculated as Laboratories, Plot No. 5-9, Available Survay No.:38/2, Aliyali Iodine Pallghar-(W) Distt. Palgarh, 401404 (M.S.). 11. Aciloc only B. No.:16010, Test for Assay CDSCO, CDTL, (Ranitidine Oral Mfg dt: 10/2016, West Zone, Mumbai Liquid) Exp dt: 09/2018, Mumbai Mfd by: M/s. Cadila Pharmaceutical Limited, 1389, Dholka-387810, Dist, Ahmedabad. 12. Rocap-20 B. No.:298114, Test for Water CDSCO, CDTL, (Piroxicam Mfg dt: 02/2017, West Zone, Mumbai Capsules) Exp dt: 01/2021, Mumbai Mfd by: M/s. Lesanto Laboratories, Plot No. 9, 10, 11 & 20, Survey No. 53, Manor Road, Palghar (E), Dist Thane, Maharashtra. 13. Rocap-20 B. No.:298113, Test for Water CDSCO, CDTL, (Piroxicam Mfg dt: 02/2017, West Zone, Mumbai Capsules) Exp dt: 01/2021, Mumbai Mfd by: M/s. Lesanto Laboratories, Plot No. 9, 10, 11 & 20, Survey No. 53, Manor Road, Palghar (E), Dist Thane, Maharashtra. 14. Kalcical-500 B. No.:1508, Assay of CDSCO, CDTL, (Tablet of Vitamin Mfg dt: 01/2016, Calcium & Sub-Zone, Mumbai D3 with Elemental Exp dt: 06/2017, Vitamin D3 Indore Calcium) Mfd by: M/s. Vintochem Pharmaceuticals, At: Industrial Area, Maxi Road, Ujjain (M.P.). 15. Lecetzy B. No.:416-136 , Test for CDSCO, CDTL, (Levocetirizine Mfg dt: 01/2016, Dissolution West Zone, Mumbai Dihydrochloride Exp dt: 12/2018, Mumbai Tablets I.P. 5 mg) Mfd by: M/s. Zee Laboratories Ltd., Behind 47, Industrial Area, Paonta Sahib-173025.16. Thyrotop-100 B. No.:TRHY0023, Assay CDSCO, CDTL, (Thyroxine Sodium Mfg dt: 09/2015, West Zone, Mumbai Tablets IP) Exp dt: 08/2017, Mumbai Mfd by: M/s. Micro Labs Limited Unit-III, R.S. No. 63/3 & 4, Thiruvandar Koil, Puducherry-605102. 17. Diethyl B. No.:287, Description & CDSCO, CDL, Carbamazine Mfg dt: 07/2015, Assay Ahmedabad Kolkata Citrate Tablets I.P. Exp dt: 06/2017, Zonal Office 50 mg Mfd by: M/s. Infinitive Pharmaceutical Industries, Plot No. 63, G.I.D.C., Industrial Estate, Disa-385535, Gujarat. 18. Gentamicin B. No.:GS672, Description & CDSCO, CDL, Sulphate Injection Mfg dt: 11/2016, Particulate South Zone, Kolkata I.P. 2 ml Exp dt: 10/2018, Matter Chennai Mfd by: M/s. Tamman Titoe Pharma Pvt. Ltd., 56-57, SIDCO Pharmaceutical Complex, Alathur-603110, Tamil Nadu. 19. Amikacin Sulphate B. No.:AK1663, Description, CDSCO, CDL, Injection I.P. 100 Mfg dt: 12/2016, Particulate South Zone, Kolkata mg - 2 ml Exp dt: 11/2018, Matter & Chennai Mfd by: M/s. Nandani Medical Sterility Laboratories Pvt. Ltd., 221/5, Bicholi Hapsi, Kanadla Road, Indore. 20. Gentamicin B. No.:GS630, Description & CDSCO, CDL, Sulphate Injection Mfg dt: 08/2016, Particulate South Zone, Kolkata I.P. 2 ml Exp dt: 07/2018, Matter Chennai Mfd by: M/s. Tamman Titoe Pharma Pvt. Ltd., 56-57, SIDCO Pharmaceutical Complex, Alathur-603110, Tamil Nadu. 21. Amitrust-250 B. No.:ZCVAB17001, Description & CDSCO, CDL, (Amikacin Mfg dt: 01/2017, Particulate South Zone, Kolkata Injection I.P.) Exp dt: 12/2018, Matter Chennai Mfd by: M/s. Yeluri Formulation Pvt. Ltd., Sy No. 296/7/6, IDA., Bollaram, Hyderabad 502325. 22. Gentamicin B. No.:GS651 , Description & CDSCO, CDL, Sulphate Injection Mfg dt: 09/2016, Particulate South Zone, Kolkata I.P. 2 ml Exp dt: 08/2018, Matter Chennai Mfd by: M/s. Tamman Titoe Pharma Pvt. Ltd., 56-57, SIDCO Pharmaceutical Complex, Alathur 603110, Tamil Nadu. 23. Absorbent Cotton B. No.:2489, Surface-active CDSCO, CDL, Wool I.P. Mfg dt: 09/2016, Substances and Sub-Zone, Kolkata Exp dt: 08/2019, water soluble Baddi Mfd by: M/s. SJD Surgicot Pvt. substances Ltd., Bhiwani Road, Jind 126103 (H.R).24. Systocillin B. No.:SY-1605, Assay CDSCO, CDL, Injection (Oxytocin Mfg dt: 02/2016, Sub-Zone, Kolkata Injection I.P.-1) Exp dt: 01/2018, Baddi Mfd by: M/s. Systochem Laboratories Ltd., B-75, Roop Nagar Ind. Area, Loni-201102. 25. Tramajack B. No.: I-12259, Assay CDSCO, CDL, (Tramadol HCl Mfg dt: 09/2016, Sub-Zone, Kolkata Injection) Exp dt: 08/2018, Baddi Mfd by: M/s. Jackson Laboratories Pvt. Ltd., Bye Pass, Majitha Road, Khanna Nagar P.O., Amritsar-143001. 26. Forcecef 1gm (For Powder) Particulate CDSCO, CDL, (Ceftrixone Matter Sub-Zone, Kolkata Injection I.P.) B. No.:10116054 , Chandigarh Mfg dt: 07/2016, Exp dt: 06/2018, Mfd by: M/s. Zeiss Pharmaceutical Pvt. Ltd., 72, EPIP, Phase-1, Jharmajri, Baddi, Solan, H.P., (For Sterile water for injection) B. No.: WB6F21, Mfg dt: 06/2016, Exp dt: 05/2019, Mfd by: M/s. Auraya Healthcare, Plot No. 80E, EPIP, Phase-I, Jharmajri, Baddi, H.P., India for sterile water for injection). 27. DFZ-6 B. No.:HSL-836, Assay CDSCO, CDL, (Deflazacort Oral Mfg dt: 12/2016, Sub-Zone, Kolkata Suspension) Exp dt: 11/2018, Baddi Mfd by: M/s. Himsagar Laboratories Limited, Kheri, Trilokpur Road, Kala Amb, Sirmour, (HP). 28. Artcef-250 B. No.: DT-0199, Dissolution CDSCO, CDL, (Cefuroxime Axetil Mfg dt: 06/2016, Hyderabad Kolkata Tablets I.P.) Exp dt: 05/2018, Zonal office Mfd by: M/s. Ethix Healthcare, 82/33, Kalka-Shimla Highway, Deonghat, Saproon, Solan, HP- 173211. 29. Erythromycin B. No.: OB 04, Dissolution CDSCO, CDL, Stearate Tablets Mfg dt: 02/2016, Hyderabad Kolkata I.P.500 mg Exp dt: 01/2018, Zonal office Mfd by: M/s. Gluconate Health Limited, 1, Health Institute Road, Kolkata-700065. 30. Absorbent Cotton B. No.:C4/12/14, Surface-active CDSCO, CDL, Wool I.P. Mfg dt: 12/2014, substances & East Zone, Kolkata Exp dt: 11/2019, Sulphated-Ash KolkataMfd by: M/s. Shanti Surgicals Pvt. Ltd. G-28, Panki Indl. Area, Site-1, Kanpur-208022. 31. Vomidan-2 ml B. No.:67ONA181, Assay, CDSCO, CDL, (Ondansetron Mfg dt: 09/2016, Particulate Sub-Zone, Kolkata Injection I.P.) Exp dt: 08/2018, Matter & Bangalore Mfd by: M/s. SPM Drugs (P) Related Ltd., SF 52/1, Main Road, K.R. Substances Palayam, Bhavani-638301 (TN). 32. Paracetamol B. No.: 2506714, Dissolution CDSCO, CDTL, Tablets IP 500 mg Mfg dt: 07/2014, Sub-Zone, Chennai Exp dt: 06/2017, Bangalore Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Ltd., Plot No. 14 II Phase, Peenya, Bangalore-560058. 33. Ferforte Tablets B. No.: CNL-026, Description CDSCO, CDTL, (Ferrous Ascorbate, Mfg dt: 11/2016, South Zone, Chennai Cyanocobalamin, Exp dt: 04/2018, Chennai Folic Acid with Mfd by: M/s. Coronet Labs Pvt. Zinc Tablets) Ltd., 176, Mauza Ogli, Nahan Road, Kala-Amb, Distt. Sirmour (HP)-173030. 34. Agni (Extra Strong B. No.: Nil, Misbranded Drugs RDTL, Bleaching Powder) Mfg dt: 08/2016, and Control Guwahati Exp dt: 01/2018, Assay Department, Mfd by: M/s. Packed by: A.M. Arunachal Enterprise, Guwahati, Assam. Pradesh 35. Bromol Plus Cough B. No.: BT-169, Assay Drugs RDTL, Expectorant Mfg dt: 09/2016, Control Guwahati Exp dt: 08/2018, Department, Mfd by: M/s. Angel Laboratories Meghalaya Pvt. Ltd., Dakshin Jagaddal, Kolkata, West Bengal. 36. Vominil Tablets B. No.:T-8304 , Dissolution Drugs RDTL, Mfg dt: 01/2016, Control Guwahati Exp dt: 12/2017, Department, Mfd by: M/s. Jackson Assam Laboratories Pvt. Ltd, Plot No. 56 & 61, Industrial Area, Phase- III, Sansarpur Terrace, Dist- Kangra, H.P.-176501. 37. Cadfen Tablets B. No.:CRT-150205, Uniformity of Drugs RDTL, Mfg dt: 02/2016, Weight and Control Guwahati Exp dt: 01/2018, Assay Department, Mfd by: M/s. Civron Assam Pharmaceuticals (A GMP Certified Company), 13, Industrial Area, Phase-III, Sansarpur, Terrace, Dist-Kangra, H.P.

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