Home› India› Ministry of Health and Family Welfare› List of Drugs, Medical Devices and Cosmetics declared as Not...
Date: 2018-06-11 Category: Not Applicable State: Union Government Country: India

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, For the Month of MAY, 2018

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

Gazette Notification

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for the month of May 2018.
  • The list includes the name of the product, batch number, manufacturing and expiry dates, manufacturer, reason for failure, and the office that drew the sample.

Key Changes

  • A total of 43 products are listed as Not of Standard Quality/Spurious/Adulterated/Misbranded.
  • Reasons for failure include: Optical Rotation, Bacterial Endotoxins, Disintegration, Related Substances, Clarity of Solution, Dissolution, Assay of Clavulanic Acid, Particulate matter, Description, Assay, Weight per sachet, Swelling of Powder, Total aerobic Microbial Count, Extractable volume, Assay/Content of Colecalciferol, Physical Parameter, Uniformity of Weight, Defect in Fabric, Identification of Valproic Acid, Water and Total Microbial Count.
  • The products were manufactured by various companies located across India, including Gujarat, Delhi, Maharashtra, Madhya Pradesh, Himachal Pradesh, Tamil Nadu, Assam, Goa, and Uttarakhand.
  • Samples were drawn by various CDSCO (Central Drugs Standard Control Organization) zonal and sub-zonal offices, as well as state Drug Control Departments and RDTLs (Regional Drugs Testing Laboratories).

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 about the list to ensure patients are not prescribed or administered these medications. Consumers who have purchased the products should be advised to discontinue use and seek medical advice if they experience any adverse effects.

Regulatory Authorities

  • Action Item: CDSCO and State Drug Controllers should strengthen surveillance and testing programs to prevent the manufacture and sale of substandard drugs. Consider increasing penalties for manufacturers of substandard drugs to deter future violations.

Distributors and Retailers

  • Action Item: Immediately remove the listed products from shelves and quarantine them for return to the manufacturer or disposal as per regulatory guidelines. Review inventory management procedures to prevent the sale of recalled or substandard products.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratory, a laboratory responsible for testing and analyzing drug samples. State Drug Control Departments: State-level regulatory bodies responsible for enforcing drug regulations within their respective states. Drugs and Cosmetics Act, 1940: The primary legislation governing the import, manufacture, distribution, and sale of drugs and cosmetics in India (Implied).
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, 2018 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. Choline Bitartrate B. No.: CBP-00711217, Optical Rotation CDSCO, CDL, NF Mfg dt: 12/2017, Zonal Office, Kolkata Exp dt: 11/2022, Ahmedabad. Mfd by: M/s. Bajaj Healthcare Limited (Unit-2), Block No. 588, Savli Karachia Road, At & Post – Gothada, Tal Savli, Distt. Vadodara, Gujarat. 2. Gentamicin B. No.: 355, Bacterial CDSCO, CDL, Sulphate Injection Mfg dt: 02/2017, Endotoxins East Zone Kolkata Exp dt: 01/2019, Kolkata. I.P. – 2 ml Mfd by: M/s. Gopish Pharma, H- 1455, DSIDC, Narela Ind. Park, Narela, Delhi – 110 040. 3. Diclofen – SR B. No.: 656, Disintegration CDSCO, CDL, (Diclofenac Mfg dt: 06/2016, Zonal Office, Kolkata Exp dt: 05/2018, Ahmedabad. Sodium Tablets Mfd by: M/s. Deep Pharma, I.P.) Khedut Sabha Building, Dholka – 382 225, Distt. Ahmedabad, Gujarat, India. 4. ONDANSETRON B. No.: ONI1612, Related CDSCO, CDL, (Ondansetron Mfg dt: 06/2016, Substances Zonal Office, Kolkata Exp dt: 05/2018, Ahmedabad. Injection I.P. 2 Mfd by: M/s. Modern mg/ml) Laboratories, 45-47, Sector D-2, Sanwer Road, Indore (M.P.) – 452 015. 5. CEFTRIAXONE B. No.: T3C441216, Clarity of CDSCO, CDL, MJ (Ceftriaxone Mfg dt: 12/2016, Solution East-Zone, Kolkata Exp dt: 11/2018, Kolkata for Injection I.P. 1 Mfd by: M/s. M.J. Biopharm g) Pvt. Ltd., L-7, MIDC Indl. Area, Taloja, Dist. Raigad, Navi Mumbai – 410 208, Maharashtra. 6. Pantoprazole B. No.: 1709012, Dissolution CDSCO, CDL, Sodium Tablets Mfg dt: 09/2017, East-Zone, Kolkata Exp dt: 02/2019 Kolkata I.P. Mfd by: M/s. Adroit Pharmaceuticals Pvt. Ltd., At.: 46, Garoba Maidan, Nagpur – 440 008.7. Licomox – 625 B. No.: SPH-057, Assay of CDSCO, CDL, Tablets Mfg dt: 02/2017, Clavulanic Acid Sub-Zone, Kolkata (Amoxycillin and Exp dt: 07/2018, and Dissolution Baddi. Potassium Mfd by: M/s. Park of Amoxycillin Clavulanate Pharmaceuticals, Vill. and Clavulanic Tablets I.P.) Kalujhanda, Near Nanakpur, Teh acid Baddi, Distt. Solan (H.P.). 8. Glanpan For Powder Particulate matter CDSCO, CDL, (Pantoprazole for B. No.: A017162D, East-Zone, Kolkata Mfg dt: 09/2017 Kolkata Injection) Exp dt: 08/2019 Mfd by: M/s. ANG Life Sciences (I) Pvt. Ltd., Vill. Kishanpura, P.O. Manpura, Tehsil Nalagarh, Distt. Solan (H.P.) – 174 101 For Sodium Chloride Injection B. No.:NB7G07, Mfg dt: 07/2017, Exp dt: 06/2020, M/s. Auraya Healthcare, Plot No. 80E, EPIP, Phase – I, Jharmajri, Baddi (HP), India 9. Oxymac (Oxytocin B. No.: OT-1642, Description and CDSCO, CDL, Inj. I.P. 5 IU) Mfg dt: 12/2016, Particulate matter Sub-Zone, Kolkata Exp dt: 11/2018, Baddi. Mfd by: M/s. Macin Remedies India Ltd., B-21, Industrial Focal Point, Moga (Pb) – 142 001. 10. Enclard – 5 B. No.: NCA-002, Assay CDSCO, CDL, (Enalapril Maleate Mfg dt: 12/2016, and East-Zone, Kolkata Exp dt: 11/2018, Dissolution of Kolkata. Tablets I.P.) Mfd by: M/s. Surien Enalapril Maleate Pharmaceuticals (P) Ltd., 108, Chekkady Street, Kovur, Chennai – 600 128. 11. Isphagula Husk B. No.: IH.6064, Weight per sachet CDSCO, CDL, Mfg dt: 08/2016, and Swelling of South-Zone, Kolkata Exp dt: 07/2018, Powder, Total Chennai. Mfd by: M/s. Vivimed Labs aerobic Microbial Limited, Plot No. 41, 44A & Count and 44B, Anrich Industrial Estate, presences of IDA, Bollaram, Medak Dist. Salmonella sp. A.P. – 502 325. 12. T-Pant 40 B. No.: 64/E4, Assay CDSCO, CDL, (Pantoprazole Mfg dt: 10/2016, Sub-Zone, Kolkata Exp dt: 09/2018, Goa. Sodium Tablets) Mfd by: M/s. Toyo Laboratories Pvt. Ltd., Ponda, Goa – 403 401, At.: 99, C & D, KIADBIndustrial Estate, Honaga, Belgaum. 13. MERIDECA B. No.: WMI16250, Extractable CDSCO, CDL, (Dexamethasone Mfg dt: 12/2016, volume (HQ), Kolkata Exp dt: 11/2018, New Delhi. Sodium Phosphate Mfd by: M/s. Micropure Injection I.P. 20 Parenterals Pvt. Ltd., 136, ml) Neharoli, Wada, Palghar – 421 312. 14. Alphadol B. No.: 30136521, Assay CDSCO, CDL, (Alfacalcidol Mfg dt: 08/2016, East-Zone, Kolkata Exp dt: 07/2018, Kolkata. Capsules 0.25 mcg) Mfd by: M/s. Panacea Biotech Ltd., Malpur, Baddi, Dist. Solan, H.P. – 173 205. 15. Phytomenadione B. No.: KPM-1602, Description and CDSCO, CDL, Injection (Vit – Mfg dt: 08/2016, Particulate Sub-Zone, Kolkata Exp dt: 07/2018, contamination Bangalore. K1) Mfd by: M/s. Systochem (Visible Laboratories Ltd., B-75, Roop Particulate) Nagar Indl. Area, Loni – 201 102. 16. Calcium and B. No.: CUTT-59, Assay/Content of CDSCO, CDL, Colecalciferol Mfg dt: 09/2016, Colecalciferol Sub-Zone, Kolkata Exp dt: 08/2018, Baddi. Tablets B.P. (500 (Vitamin D ) 3 Mfd by: M/s. Karnataka mg + 250 IU) Antibiotics & Pharmaceuticals (Calcium and Limited, at, 11, Western Vitamin D 3 Extension Area, Faridabad – 121 (Colecalciferol) 001. Tablets) 17. Brodagesic SP B. No.: KN-107, Description and CDSCO, CDL, (Diclofenac Mfg dt: 05/2017, Assay of (HQ), Kolkata Potassium, Exp dt: 04/2019, Serratiopeptidase New Delhi. Paracetamol & Mfd by: M/s. Amree Serratiopeptidase Pharmaceuticals, Plot No. 1, Tablets) Street 10, Kaithal Road, Karnal – 132 001. 18. ACEONE-SP B. No.: PT-9714, Assay/Content of CDSCO, CDL, Tablets Mfg dt: 03/2017, Aceclofenac Sub-Zone, Kolkata (Aceclofenac, Exp dt: 02/2019, Goa. Paracetamol & Mfd by: M/s. Panm Biotech Pvt. Serratiopeptidase Ltd., Village Moginand, Nahan Tablets) Road, Kala-Amb, Distt. Sirmour (H.P.) – 173 030.19. S-Amlodipine B. No.: T-5285, Assay Drugs Control RDTL, Tablets I.P. Mfg dt: 02/2017, Department, Guwahati Exp dt: 01/2019, Assam Mfd by: M/s. Kwality Pharmaceuticals Ltd., Nag Kalan, Majitha Road, Amritsar 20. Bromol Plus B. No.: BT-197, Physical Drugs Control RDTL, Cough Expectorant Mfg dt: 11/2017, Parameter Department, Guwahati Exp dt: 10/2019, Meghalaya Mfd by: M/s. Angel Laboratories (P) ltd., Dakshin Jagaddal, Kolkata-51 21. Bromol Plus B. No.: BT-199, Physical Drugs Control RDTL, Cough Expectorant Mfg dt: 11/2017, Parameter Department, Guwahati Exp dt: 10/2019, Meghalaya Mfd by: M/s. Angel Laboratories (P) ltd., Dakshin Jagaddal, Kolkata-51 22. Cefosun-200 B. No.: B-1364, Dissolution Drugs Control RDTL, Tablets Mfg dt: 09/2017, Department, Guwahati Exp dt: 08/2019, Kolkata Mfd by: M/s. Sunrise Remedies Pvt. Ltd, Block No. 2244, Opp. Shah Steel, Santej, Ta: Kalol, Gandhinagar 23. Paracetamol B. No.: 5481007, Physical Drugs Control RDTL, Tablets I.P. Mfg dt: 09/2015, Parameter & Department, Guwahati Exp dt: 08/2018, Assam Uniformity of Mfd by: M/s. Bengal Chemical Weight & Pharmaceuticals Ltd., 164, Maniktala Main Road, Kolkata- 700054 24. Paracetamol B. No.: 5481005, Physical Drugs Control RDTL, Tablets I.P. Mfg dt: 09/2015, Parameter & Department, Guwahati Exp dt: 08/2018, Assam Uniformity of Mfd by: M/s. Bengal Chemical Weight & Pharmaceuticals Ltd., 164, Maniktala Main Road, Kolkata- 700054 25. Paracetamol B. No.: 5481004, Physical Drugs Control RDTL, Tablets I.P. Mfg dt: 08/2015, Parameter Department, Guwahati Exp dt: 07/2018, & Assam Mfd by: M/s. Bengal Chemical Uniformity of & Pharmaceuticals Ltd., 164, Weight Maniktala Main Road, Kolkata- 700054 26. Diazepam Injection B. No.: DZ1704, Description CDSCO, CDTL, IP Mfg dt: 05/2017, South-Zone, Chennai Exp dt: 04/2019, Chennai Mfd by: M/s. Nandani Medical Laboratories Pvt. Ltd., 221/5,Bicholi Hapsi, Kanadia Road, Indore. 27. Ranitidine B. No.: 1027, Assay CDSCO, CDTL, Hydrochloride Mfg dt: 02/2018, Hyderabad Chennai Exp dt: 01/2020, Zonal office Tablets IP 150mg Mfd by: M/s. Seeko Biotics Krishna Nagar-522502 28. Prozol-P B. No.: 27-72, Dissolution CDSCO, CDTL, (Pantoprazole Mfg dt: 02/2017, West-Zone, Mumbai Exp dt: 07/2019, Mumbai Tablets IP) Mfd by: M/s. HAB Pharmaceuticals & Research Ltd., 10, Pharmacity, SIDCUL, Selaqui, Dehradun-248197. 29. Prohibin B. No.: 7005, Dissolution CDSCO, CDTL, (Omeprazole Mfg dt: 05/2017, West-Zone, Mumbai Exp dt: 04/2019, Mumbai Capsules IP) Mfd by: M/s. Lesanto Laboratories, Plot No. 9, 10, 11 & 20, Survey No.53, Palghar- 401404. 30. Rolled (Gauze B. No.: 86, Defect in Fabric, CDSCO, CDTL, SCH F II) Mfg dt: 03/2016, Odour, Skewness, West-Zone, Mumbai Exp dt: 03/2019, Cracks, Double Mumbai Mfd by: M/s. Sundaram Ends, Sloughing, Surgical, Chatrapatti-626102. Threads per DM (Warp & Weft), Weight in g/m2, Length and Foreign Matter 31. Rabeprazole (EC) B. No.: SOC-587, Dissolution CDSCO, RDTL, and Domperidone Mfg dt: 12/2017, (Rabeprazole Sub-Zone, Chandigarh Exp dt: 11/2019, Sodium) (In Baddi. (SR) Capsules Mfd by: M/s. Symbiosis Acidic medium), (OLEZ-DSR Pharmaceuticals Pvt. Ltd., (Unit- (In Buffer CAPSULES) III) Plant at: Trilokpur Road, Medium), Kala Amb-173030 (HP). Dissolution (Domperidone Sustained release) 32. Sodium Valproate B. No.: VCR1197D, Identification of CDSCO, RDTL, Tablets 200 mg Mfg dt: 06/2017, Valproic Acid, North-Zone, Chandigarh Exp dt: 05/2019, Ghaziabad (VAT CR 200 Assay of Sodium Mfd by: M/s. Pulse TABLETS) Valproate and Pharmaceuticals Pvt. Ltd., Valproic Acid. Khasra No.400, 407, 409, Karondi, Roorkee, Uttarakhand - 247667.33. Chlorhexidine B. No.: NLE458, Assay of CDSCO, RDTL, Gluconate, Mouth Mfg dt: 04/2017, Chlorhexidine Sub-Zone, Chandigarh wash IP (DENTO Exp dt: 03/2019, Gluconate Baddi FRESH MOUTH Mfd by: M/s. Neptune Life Solution Diluted WASH) Sciences Pvt. Ltd., 100-B, EPIP calculated as Phase-II, Thana, Baddi-173205 Chlorhexidine (H.P.) Gluconate 34. Cefotaxime B. No.: I-11820, Water Drug Control RDTL, Sodium Injection Mfg dt: 07/2016, Department, Chandigarh BP (CEFOX-125 Exp dt: 06/2018, H.P. INJECTION) Mfd by: M/s. Jackson Laboratories Pvt. Ltd., Bye Pass, Majitha Road, Amritsar-143001. 35. Clarithromycin B. No.: C-70357, Dissolution CDSCO, RDTL, Tablets IP 250 mg Mfg dt: 05/2017, (Clarithromycin) Sub-Zone, Chandigarh Exp dt: 04/2019, Baddi (KLARIM Mfd by: M/s. Morepen TABLETS) Laboratories Limited, Unit-V, Plot No.12-C, Sector-2, Parwanoo, Distt. Solan (H.P.)-173220 36. Fuor Lovely Multi B. No.: 01, Total Microbial Drugs Control RDTL, Vitam Premium Mfg dt: 01/2018, Count Department, Chandigarh Beauty Cream Exp dt: 12/2021, Delhi. Mfd by: M/s. Vidhi Cosmetics, Delhi 37. Ondansetron B. No.: Ql-2432, Related CDSCO, RDTL, Injection IP Mfg dt: 07/2016, Substances Sub-Zone, Chandigarh Exp dt: 06/2018, Baddi (ONDET Mfd by: M/s. Quixotic INJECTION) Healthcare, Unit-II, Vill. Kalujhanda, Baddi, Distt.Solan (H.P.) 38. Calcium Citrate, B. No.: UDT-7595B, Disintegration CDSCO, RDTL, Magnesium, Zinc Mfg dt: 09/2017, Test and the Sub-Zone, Chandigarh and Vitamin D3 Exp dt: 08/2019, Assay of Vitamin Baddi Tablets (CALIVE Mfd by: M/s. Ultra Drug Pvt. D3 TABLETS) Ltd., Manpura, Nalagarh, Distt. Solan (H.P.) 39. Vitamin B- B. No.: ULT-1139, Identification B CDSCO, RDTL, Complex with Mfg dt: 01/2018, and the Assay of Sub-Zone, Chandigarh Exp dt: 06/2019, Calcium Baddi Minerals Tablets Mfd by: M/s. Ultratech Pantothenate, (COMVITA-M Pharmaceuticals, Vill. Tipra, Chromium TABLETS) P.O.Barotiwala, Distt.Solan Chloride (H.P.) calculated as Elemental Chromium40. Omega 3 Fatty B. No.: D1608128, Assay CDSCO, RDTL, Acid, Mfg dt: 08/2016, of Sub-Zone, Chandigarh Methylcobalamin, Exp dt: 07/2018, Methylcobalamin Baddi Calcitriol, Calcium Mfd by: M/s. Mas Pharmachem, and Folic Acid Village Dattowal, Manali Road, Softgel Capsules Tehsil Nalagarh, Distt.Solan (HI-LIFE (H.P.) CAPSULES) 41. Paracetamol B. No.: ABSL17-265, Assay Sirmour RDTL, Suspension IP Mfg dt: 12/2017, of (Distt), H.P. Chandigarh Exp dt: 11/2019, Paracetamol (KIDMOL-250 Mfd by: M/s. ALEXIN SUSPENSION) Biosciences, Vill.-Barotiwala, Plot No.151/196, Paonta Sahib, Distt.-Sirmour, Himachal Pradesh-173025 42. Glimepiride B. No.: GL2G37, Dissolution CDSCO, RDTL, Tablets IP 2 MG Mfg dt: 02/2017, North-Zone, Chandigarh Exp dt: 01/2020, Ghaziabad Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, L-43, Verna Indl. Estate, Verna, Salcete, Goa- 403722. 43. Glimepiride B. No.: GL1G17, Dissolution CDSCO, RDTL, Tablets IP 1 MG Mfg dt: 02/2017, North-Zone, Chandigarh Exp dt: 01/2020, Ghaziabad Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, L-43, Verna Indl. Estate, Verna, Salcete, Goa- 403722.

Continue your research

Related Documents from Ministry of Health and Family Welfare