Home› India› Ministry of Health and Family Welfare› Drug Alert list for month of May 2019...
Date: 2019-06-12 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of May 2019

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

Research with AI Agent Chat with Document Generate Summary Translate Helpful Share Add to Project Create Task

Executive Summary & Key Takeaways

What it means

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for May 2019.
  • A total of 821 samples were tested, with 33 samples failing to meet the required quality standards.

Key Changes

  • Out of 821 samples tested, 788 samples were declared as of Standard Quality.
  • 33 samples were declared as Not of Standard Quality/Spurious/Misbranded.
  • The notification provides a detailed list of the 33 failed samples, including the name of the drug/medical device/cosmetic, batch number, manufacturing and expiry dates, manufacturer details, reason for failure, and the testing laboratory.
  • Reasons for failure include: Assay issues, Dissolution issues, Related Substances issues, Particulate Matter issues, Description issues, Uniformity of Content issues, Free Salicylic Acid Test failure and Disintegration issues.
  • The listed manufacturers are located across various states including Madhya Pradesh, Uttarakhand, Gujarat, Himachal Pradesh, Assam, Maharashtra, Puducherry, Karnataka, Arunachal Pradesh, Tripura, Mizoram, Punjab, Jammu & Kashmir and Haryana.

Impact Analysis

Impact on Manufacturers

  • Action Item: Immediately investigate the root cause of the quality failures and implement CAPA to prevent recurrence. Engage with regulatory authorities to address concerns and demonstrate commitment to quality.

Impact on Distributors/Retailers

  • Action Item: Verify inventory against the list of substandard products and initiate recalls as necessary. Strengthen supplier quality agreements and audit processes.

Impact on Consumers

  • Action Item: Raise awareness among consumers about the listed substandard products and advise them to discontinue use. Encourage reporting of any adverse events experienced.

Impact on Regulatory Authorities

  • Action Item: Strengthen post-market surveillance and enforcement activities. Review and update quality standards and guidelines to ensure effectiveness.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. CDL: Central Drugs Laboratory RDTL: Regional Drugs Testing Laboratory Deepin Pharmaceuticals Pvt. Ltd.: Manufacturer of FURAZOLIDONE ORAL SUSPENSION IP, batch B. No.: 1803 Synokem Pharmaceuticals Ltd.: Manufacturer of Misoprostol Tablets I.P. 200 mcg MST, batch B. No.: 18SGET035 Omega Pharma: Manufacturer of Erythromycin Stearate Tablets I.P. 250mg, batches B. No.: GPT005 and GPT003 Psychotropics India Limited: Manufacturer of Valate 200 (Sodium Valproate Gastro-Resistant Tablets I.P. 200 mg), batch B. No.: ACJ28001 Swiss Parenterals Ltd.: Manufacturer of NORSHOT (Sterile Noradrenaline Concentrate I.P. 2 mg/ml, 2ml), batch B. No.: 17200 Bharat Parenterals Ltd.: Manufacturer of MARIAGO (Methylergometrine Maleate Injection I.P.), batch B. No.: P7274 MMG Healthcare: Manufacturer of Herzovir Lyophillized Powder (Aciclovir Intravenous Infusion I.P.), batch B. No.: GN1310A Phoenix Laboratories: Manufacturer of COMBit (Tablets of Botin, Iron, Lysine, N-Acetyl Cysteine, Vitamin B12 & Minerals), batch B. No.: 1801820 Karnataka Antibiotics & Pharmaceuticals Limited: Manufacturer of Calcium and Vitamin D3 Tablets I.P., batch B. No.: KTB8010AL Hab Pharmaceuticals & Research Limited: Manufacturer of Betahistine Tablets I.P. 16 mg, batch B. No.: 767-02 Iosis Remedies: Manufacturer of Clopican* A (Clopidogrel Bisulphate and Aspirin Tablets), batch B. No.: CCAT-018 Goodman Pharmaceuticals: Manufacturer of Atriflam (Aceclofenac, Paracetamol & Serratiopeptidase Tablets), batch B. No.: SAMT1803 Elegant Drugs Pvt. Ltd.: Manufacturer of Serratiopeptidase Tablets I.P. 10 mg, batch B. No.: EST13 Ramson Remedies: Manufacturer of Frusemide Tablets I.P. 40 mg, batch B. No.: 7127 Neon Laboratories Ltd.: Manufacturer of Artesunate Injection (Neosunate), batch B. No.: 115825 Omega Biotech Ltd.: Manufacturer of Paracetamol Tablets I.P. 500 mg., batch B. No.: CT70154 Athens Life sciences: Manufacturer of Telmisartan Tablets I.P. 20 mg. (Ezisartan 20), batch B. No.: VT17-4089 Park Pharmaceuticals: Manufacturer of Ofloxacin Tablets I.P. (DRFLOX-200), batch B. No.: DRB-009 Vintochem Pharmaceuticals: Manufacturer of Chlorpheniramine Maleate Tablets IP 4 mg (CPM), batch B. No.: 1809 Zim Laboratories Limited: Manufacturer of Parazim-20 (Omeprazole Gastro-Resistant Capsules IP 20 mg), batch B. No.: FZ04B802 Jackson Laboratories Pvt. Ltd: Manufacturer of Menadione Sodium Bisulphate Injection IP (1966) 10mg/ml (VITAMIN K3 INJECTION), batch B. No.: I-17549 and PRIMAQUINE PHOSPHATE TABLETS IP 2.5 MG), batch B. No.: T-17648 Sunlife Sciences: Manufacturer of Atorvastatin Tablets IP (LIPVEN-20 TABLETS), batch B. No.: VT-17230 Boffin Biotech Pvt. Ltd.: Manufacturer of Loperamide Hydrochloride Tablets IP (LOPSOL TABLETS), batch B. No.: BT-391 ZIM Laboratories Limited (Unit-II): Manufacturer of Ramipril Tablets IP 2.5 mg (RAMIZIM-2.5 TABLETS), batch B. No.: EH97F801 Scott-Edil Pharmacia Ltd.: Manufacturer of Fluconazole Tablets IP (FLUTIS-150 TABLETS), batch B. No.: SDS874 VADSP PHARMACEUTICALS: Manufacturer of Chloramphenicol and Dexamethasone Sodium Eye Drops (POLYMICIN EYE DROPS), batch B. No.: POLY-07 Shreya Life Sciences Pvt Ltd: Manufacturer of Hyaluronidase Injection IP (Ovine) (HYNIDASE INJECTION), batches B. No.: SA1812059 and SA1812060 CIPLA LTD: Manufacturer of Nitrofurantoin Capsules USP 100mg (URIFAST CAPSULES), batch B. No.: BA82286 ARISTO Pharmaceuticlas Pvt. Ltd.: Manufacturer of Amlodipine Tablets IP 10 mg (AMLOSAFE 10 TABLETS), batch B. No.: M129L018
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 May 2019 Total number of samples tested 821 Total number of samples declared as of Standard Quality 788 Total number of samples declared as Not of Standard Quality /Spurious /Misbranded (under Form-13, Form-34 and Form- MD-32) 33 S. Name of Batch No./Date of Reason for Drawn By From N. Drugs/medical Manufacture/Date of failure device/cosmetics Expiry/Manufactured By 1. FURAZOLIDONE B. No.: 1803, Assay CDSCO, S.R. CDTL, ORAL Mfg dt: 06/2018, Nagar, Chennai SUSPENSION IP Exp dt: 05/2020, Hyderabad Mfd by: M/s. Deepin Pharmaceuticals Pvt. Ltd., Village: Dharwara, Post: Kalaria – 453001, Tehsil: Depalpur (MP). 2. Misoprostol Tablets B. No.: 18SGET035, Assay CDSCO, CDL, I.P. 200 mcg MST Mfg dt: 05/2018, North Zone, Kolkata Exp dt: 04/2020, Ghaziabad Mfd by: M/s. Synokem Pharmaceuticals Ltd., Plot No. 35-36, Sector-6A, Integrated Industrial Estate (SIDCUL), Ranipur (BHEL), Haridwar 249403, Uttarakhand. 3. Erythromycin B. No.: GPT005, Dissolution CDSCO, CDL, Stearate Tablets I.P. Mfg dt: 10/2018, North Zone, Kolkata Exp dt: 09/2020, 250mg Ghaziabad Mfd by: M/s. Omega Pharma, Khasra No. 482, Village-Saliyar, Roorkee- 247667, Distt. Haridwar, Uttarakhand. 4. Erythromycin B. No.: GPT003, Dissolution CDSCO, CDL, Stearate Tablets I.P. Mfg dt: 10/2018, North Zone, Kolkata Exp dt: 09/2020, 250mg Ghaziabad Mfd by: M/s. Omega Pharma, Khasra No. 482, Village-Saliyar, Roorkee- 247667, Distt. Haridwar, Uttarakhand. 5. Valate 200 (Sodium B. No.: ACJ28001, Related CDSCO, Sub- CDL, Valproate Gastro- Mfg dt: 06/2018, substances Zone, Kolkata Exp dt: 05/2020, Resistant Tablets Hyderabad Mfd by: M/s. Psychotropics I.P. 200 mg) India Limited, Plot No. 46 & 49, Sector-6A, IIE Sidcul,Ranipur, Haridwar - 249403, Uttarakhand. 6. NORSHOT (Sterile B. No.: 17200, Description & CDSCO, Sub- CDL, Noradrenaline Mfg dt: 11/2017, Particulate Zone, Kolkata Exp dt: 10/2019, Concentrate I.P. 2 Matter Hyderabad Mfd by: M/s. Swiss mg/ml, 2ml) Parenterals Ltd., 809, Kerala G.I.D.C., Nr. Bavla Dist. Ahmedabad-382220, Gujarat. 7. MARIAGO B. No.: P7274, Assay CDSCO, Sub- CDL, (Methylergometrine Mfg dt: 06/2017, Zone, Kolkata Exp dt: 05/2019, Maleate Injection Hyderabad Mfd by: M/s. Bharat I.P.) Parenterals Ltd., Vill. Haripura, Ta. Savli, Dist. Vadodara -391520, Gujarat. 8. Herzovir Lyophillized B. No.: GN1310A, Particulate CDSCO, Sub CDL, Powder (Aciclovir Mfg dt: 11/2017, Matter Zone, Baddi Kolkata Exp dt: 10/2019, Intravenous Infusion Mfd by: M/s. MMG I.P.) Healthcare, Trilokpur Road, Kala Amb, Distt. Sirmour, 173030, Himachal Pradesh. 9. COMBit (Tablets of B. No.: 1801820, Assay of ‘N- CDSCO, East CDL, Botin, Iron, Lysine, Mfg dt: 06/2018, Acetyl Cysteine’ Zone, Kolkata Kolkata Exp dt: 11/2019, N-Acetyl Cysteine, and ‘Zinc Mfd by: M/s. Phoenix Vitamin B12 & Sulphate Laboratories, Vill. Minerals) Monohydrate’ Narayanpur, 105 No. Kochpara Gaon Panchyat, Dist.- Kamrup, Mirza, Assam -781125. 10. Calcium and Vitamin B. No.: KTB8010AL, Assay of CDSCO, East CDL, D3 Tablets I.P. Mfg dt: 07/2018, ‘Vitamin D3’ Zone, Kolkata Kolkata Exp dt: 06/2020, Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, At: Plot No-5-9, Survey No.38/2, Aliyali Palghar (W), Dist. Palghar 401 404, Maharashtra. 11. Betahistine Tablets B. No.: 767-02, Assay & CDSCO, East CDL, I.P. 16 mg Mfg dt: 07/2017, Uniformity of Zone, Kolkata Kolkata Exp dt: 12/2019, Content Mfd by: M/s. Hab Pharmaceuticals & Research Limited, 10, Pharmacity, SIDCUL, Selaqui, Dehradun- 248197, Uttarakhand.12. Clopican* A B. No.: CCAT-018, Free Salicylic CDSCO, East CDL, (Clopidogrel Mfg dt: 10/2018, Acid Test Zone, Kolkata Kolkata Exp dt: 09/2020, Bisulphate and Mfd by: M/s. Iosis Aspirin Tablets) Remedies, Rajpura Road, ViII. Khera Nihla, Teh. Nalagarh, Dist. Solan, H.P. 174 101. 13. Atriflam B. No.: SAMT1803, Assay of CDSCO, CDL, (Aceclofenac, Mfg dt: 10/2018, Serratiopeptidase South Zone, Kolkata Exp dt: 09/2020, Paracetamol & Chennai Mfd by: M/s. Goodman Serratiopeptidase Pharmaceuticals, Plot No. Tablets) B3-B8, PIPDIC Electronic Park, Thirubhuvanai, Puducherry 605107. 14. Serratiopeptidase B. No.: EST13, Assay & CDSCO, Sub CDL, Tablets I.P. 10 mg Mfg dt: 07/2017, Disintegration Zone, Kolkata Exp dt: 06/2019, Bangalore Mfd by: M/s. Elegant Drugs Pvt. Ltd., R.S. No. 59/3A, Chalmatti -581196 Dist. Dharwad State, Karnataka. 15. Frusemide Tablets B. No.: 7127, Dissolution Drugs Control RDTL, I.P. 40 mg Mfg dt: 06/2017, Department Guwahati Exp dt: 05/2020, Arunachal Mfd by: M/s. Ramson Pradesh Remedies 186-187, Industrial Focal Points, Amritsar, A.O., 2G Floor, Baktawar, Malbar Hill, Mumbai-6. 16. Artesunate Injection B. No.: 115825, Particulate Drugs Control RDTL, (Neosunate) Mfg dt: 06/2018, Contamination Department Guwahati Exp dt: 05/2020, Tripura Mfd by: M/s.Neon Laboratories Ltd., 28, Mahal Ind. Est. M. Caves RD. Andheri (East), Mumbai-400093. 17. Paracetamol Tablets B. No.: CT70154, Dissolution Drugs Control RDTL, I.P. 500 mg. Mfg dt: 06/2017, Department Guwahati Exp dt: 05/2019, Assam Mfd by: M/s. Omega Biotech Ltd. 7th Mile Stone, Dehradun Road, Roorkee, Uttrakhand-247667. 18. Telmisartan Tablets B. No.: VT17-4089, Dissolution Drugs Control RDTL, I.P. 20 mg. Mfg dt: 11/2017, Department Guwahati Exp dt: 10/2019, (Ezisartan 20) Mizoram Mfd by: M/s. Athens Life sciences Mauza, Rampur Jattan, Nahan Road, Kala- Amb, Dist. Sirmour, H.P.-173030 19. Ofloxacin Tablets B. No.: DRB-009, Dissolution Drugs Control RDTL, I.P. (DRFLOX-200) Mfg dt: 07/2017, Department Guwahati Exp dt: 06/2019, Mizoram Mfd by: M/s. Park Pharmaceuticals Vill- Kalujhanda, Near Nanakpur, Teh. Baddi, Dist. Solan, (H.P.)-174103. 20. Chlorpheniramine B. No.: 1809, Related CDSCO, CDTL, Maleate Tablets IP 4 Mfg dt: 11/2018, Substances West Zone, Mumbai Exp dt: 10/2020, mg (CPM) Mumbai Mfd by: M/s.Vintochem Pharmaceuticals, Industrial Area, Maxo Road, Ujjain, 456010 (M.P.). 21. Parazim-20 B. No.: FZ04B802, Dissolution CDSCO, CDTL, (Omeprazole Mfg dt: 02/2018, West Zone, Mumbai Exp dt: 01/2021, Gastro-Resistant Mumbai Mfd by: M/s.Zim Capsules IP 20 mg) Laboratories Limited, B- 21/22, MIDC Area, Kalmeshwar-441501, Dist. Nagpur, Maharashtra. 22. Menadione Sodium B. No.: I-17549, Particulate CDSCO, RDTL, Bisulphate Injection Mfg dt: 08/2018, matter South.Zone, Chandigarh Exp dt: 07/2020, Baddi IP (1966) 10mg/ml Mfd by: M/s.Jackson (VITAMIN K3 Laboratories Pvt. Ltd, INJECTION) Majitha Road, Bye Pass, Amritsar-143001, Punjab. 23. Atorvastatin Tablets B. No.: VT-17230, Dissolution CDSCO, RDTL, IP (LIPVEN-20 Mfg dt: 12/2017, (Atorvastatin North Zone, Chandigarh Exp dt: 11/2019, TABLETS) Calcium Ghaziabad Mfd by: M/s. Sunlife calculated as Sciences 130, Kurdi, Atorvastatin) Jhabrera Road, Manglour, Roorkee, Distt. Haridwar (U.K.). 24. PRIMAQUINE B. No.: T-17648, Dissolution Drug RDTL, PHOSPHATE Mfg dt: 08/2018, Controller Chandigarh Exp dt: 07/2020, TABLETS IP 2.5 Jammu & Mfd by: M/s. Jackson MG) Kashmir Laboratories Pvt. Ltd. Majitha Road, Bye Pass, Amritsar-143001(India). 25. Loperamide B. No.: BT-391, Dissolution H.P. State RDTL, Hydrochloride Mfg dt: 08/2018, Chandigarh Exp dt: 07/2020, Tablets IP Mfd by: M/s. Boffin Biotech (LOPSOL TABLETS) Pvt. Ltd., Vill. Behral, Paonta Sahib, Distt. Sirmour-173025 (H.P.).26. Ramipril Tablets IP B. No.: EH97F801, Assay CDSCO, RDTL, 2.5 mg (RAMIZIM- Mfg dt: 06/2018, North Zone, Chandigarh Exp dt: 05/2020, 2.5 TABLETS) Ghaziabad Mfd by: M/s. ZIM Laboratories Limited (Unit- II) A-8/14, MIDC Area, Kalmeshwar-441501, Dist. Nagpur, Maharashtra. 27. Fluconazole Tablets B. No.: SDS874, Dissolution CDSCO, RDTL, IP (FLUTIS-150 Mfg dt: 05/2018, North Zone, Chandigarh Exp dt: 04/2020, TABLETS) Ghaziabad Mfd by: M/s. Scott-Edil Pharmacia Ltd. 56, E.P.I.P., Phase-1, Jharmajri, Baddi, Distt. Solan-173205 (H.P.) INDIA. 28. Chloramphenicol B. No.: POLY-07, Assay of CDSCO, Sub- RDTL, and Dexamethasone Mfg dt: 07/2018, Chloramphenicol, Zone, Baddi Chandigarh Sodium Eye Drops Exp dt: 06/2020, and Mfd by: M/s. VADSP (POLYMICIN EYE Dexamethasone PHARMACEUTICALS Plot Sodium DROPS) No.: 124, E.P.I.P. Ind. Phosphate Area, Phase-1, Jharmajri, Baddi (H.P.). 29. Hyaluronidase B. No.: SA1812059, Particulate State RDTL, Injection IP (Ovine) Mfg dt: 06/2018, matter Haryana Chandigarh Exp dt: 05/2021, (HYNIDASE Mfd by: M/s. Shreya Life INJECTION) Sciences Pvt Ltd, B-9/2, M.I.D.C. Waluj- 431136 (Dist.- Aurangabad), Maharashtra. 30. Hyaluronidase B. No.: SA1812060, Particulate State RDTL, Injection IP (Ovine) Mfg dt: 06/2018, matter Haryana Chandigarh Exp dt: 05/2021, (HYNIDASE Mfd by: M/s. Shreya Life INJECTION) Sciences Pvt. Ltd, B-9/2, M.I.D.C. Waluj- 431136 (Dist.-Aurangabad), Maharashtra. 31. Hyaluronidase B. No.: SA1812059, Particulate State RDTL, Injection IP (Ovine) Mfg dt: 06/2018, matter Haryana Chandigarh Exp dt: 05/2021, (HYNIDASE Mfd by: M/s. Shreya Life INJECTION) Sciences Pvt Ltd, B-9/2, M.I.D.C. Waluj- 431136 (Dist.- Aurangabad), Maharashtra. 32. Nitrofurantoin B. No.: BA82286, Dissolution CDSCO, RDTL, Capsules USP Mfg dt: 07/2018, North Zone, Chandigarh Exp dt: 06/2020, 100mg (URIFAST Ghaziabad Mfd by: M/s. CIPLA LTD CAPSULES) Malpur, Distt. Solan 173205 INDIA, Himachal Pradesh.33. Amlodipine Tablets B. No.: M129L018, Dissolution C DSCO, RDTL, IP 10 mg Mfg dt: 11/2018, North Zone, Chandigarh Exp dt: 10/2020, (AMLOSAFE 10 Ghaziabad Mfd by: M/s. ARISTO TABLETS) Pharmaceuticlas Pvt. Ltd. Plot No. 208, New Industrial Area No.2, Mandideep, Distt.: Raisen (M.P.) At: Plot No. 209, New Industrial Area No. 2, Mandideep, Distt. Raisen (M.P.).

Continue your research

Related Documents from Ministry of Health and Family Welfare