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Date: 2019-01-09 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of December 2018

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

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Executive Summary & Key Takeaways

What it means

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

Key Changes

  • A total of 28 products are listed as Not of Standard Quality/Spurious/Adulterated/Misbranded.
  • The products include injections, tablets, creams, and capsules.
  • Reasons for failure include description and particulate matter, assay issues, dissolution problems, related substances, disintegration time, identification issues and presence of 2-Chlorotitanol.
  • Multiple batches of Levocetirizine Tablets I.P. 5 mg manufactured by M/s. Karnataka Antibiotics & Pharmaceuticals Limited are listed.
  • Several products failed due to dissolution issues, including Loprin-DS, P-Zide 500, Enalapril Maleate Tablets, Levocetirizine Hydrochloride Tablets and Omeprazole Capsules.
  • Several products are manufactured in Himachal Pradesh and Uttarakhand.
  • Testing was conducted by various CDSCO zones and CDL/RDTL laboratories across India.

Impact Analysis

Manufacturers

  • Review and strengthen quality control processes, including raw material sourcing, manufacturing processes, and testing procedures.

Distributors/Retailers

  • Maintain proper records of product sourcing and batch numbers for traceability.

Consumers

  • Promote reporting of suspected substandard or spurious drugs to the relevant authorities.

Regulatory Authorities

  • Enhance collaboration between central and state drug regulatory authorities.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. CDL: Central Drugs Laboratory, a national drug testing laboratory. RDTL: Regional Drugs Testing Laboratory, a regional drug testing laboratory. IP: Indian Pharmacopoeia, the official book of standards for drugs manufactured and marketed in India.
Official Source Record View Original Source →
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, For the Month of December, 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. MIKACIN INJ. 2 ML B. No.: B02H028, Description and CDSCO, CDL, (Amikacin Sulphate Mfg dt: 08/2018, Particulate Matter Hyderabad Kolkata Injection I.P.) Exp dt: 07/2021, Mfd by: M/s. Aristo Laboratories Pvt. Ltd., Village Makhnumajra, P.O. Bhud, Baddi, Dist.Solan (H.P.) - 173205. 2. VOLTANEURON DN B. No.: VDN1018D, Assay of CDSCO, South CDL, (Benfotiamine, Mfg dt: 01/2018, Methylcobalamin Zone, Chennai Kolkata Alpha Lipoic Acid, Exp dt: 06/2019, Methylcobalamin, Mfd by: M/s. Pulse Pyridoxine Pharmaceuticals Pvt. Ltd., Hydrochloride and Khasra No 400, 407, 409 Inositol Tablets) Karondi, Roorkee, Uttarakhand 247667. 3. DEXAMETHASONE B. No.: DU16002, Assay CDSCO, South CDL, Tablets I.P. 0.5 mg Mfg dt: 03/2016, Zone, Chennai Kolkata Exp dt: 02/2019, Mfd by: M/s. Baader Schulz Laboratories, Pharma Division, Plot No. J- 6, OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman 396 210, U.T., India. 4. LOPRIN-DS (Aspirin B. No.: DLS-17002, Description, CDSCO, East CDL, Gastro-Resistant Mfg dt: 01/2017, Dissolution and Zone, Kolkata Kolkata test for Salicylic Tablets I.P.) Exp dt: 12/2018, Acid Mfd by: M/s. Kalindi Medicure Pvt. Ltd., Plot No. 25 & 26, Pharma City, Selaqui Industrial Area, Dehradun (Uttarakhand). 5. LEVOCETIRIZINE B. No.: 9700617, Related CDSCO, East CDL, Tablets I.P. 5 mg Mfg dt: 01/2017, Substances Zone, Kolkata Kolkata Exp dt: 12/2019, Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, Plot No:14, II Phase, Peenya, Bangalore 560058.6. LEVOCETIRIZINE B. No.: 9702217, Related CDSCO, East CDL, Tablets I.P. 5 mg Mfg dt: 07/2017, Substances Zone, Kolkata Kolkata Exp dt: 06/2020 Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, Plot No:14, II Phase, Peenya, Bangalore 560058. 7. LEVOCETIRIZINE B. No.: 9701816, Related CDSCO, East CDL, Tablets I.P. 5 mg Mfg dt: 08/2016, Substances Zone, Kolkata Kolkata Exp dt: 07/2019, Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, Plot No:14, II Phase, Peenya, Bangalore 560058. 8. BETNOVATE-N B. No.: EW834, Assay of CDSCO, East CDL, (Betamethasone Mfg dt: 11/2017, Neomycin Zone, Kolkata Kolkata Exp dt: 04/2019, Valerate and Sulphate Mfd by: M/s. Glaxo Neomycin Skin SmithKline Pharmaceuticals Cream) Limited, At: Plot No. C-1, Madkaim Industrial Estate, Post -Mardol, Ponda, Goa – 403 404. 9. P-ZIDE 500 B. No.: JK18003, Dissolution CDSCO, East CDL, (Pyrazinamide Mfg dt: 04/2018, Zone, Kolkata Kolkata Tablets I.P.) Exp dt: 03/2022, Mfd by: M/s. Cadila Pharmaceuticals Limited, Industrial Growth Center, Samba – 184 121 State of J & K. 10. SERATID – 10 B. No.: SMD-17K240, Assay CDSCO, CDL, TABLETS Mfg dt: 11/2017, SubZone Goa Kolkata (Serratiopeptidase Exp dt: 04/2019, Tablets I.P. 10 mg) Mfd by: M/s. SMD Chemi Pharma Pvt. Ltd., Kumarhatti, Distt. Solan-173 229 (H.P.). 11. AMLOMAX B. No.: AMLT505, Related C D S C O , W e s t CDTL, (Amlodipline Mfg dt: 11/2017, Substances Zone, Mumbai Mumbai Tablets I.P. 2.5 mg) Exp dt: 10/2019, Mfd by: M/s. Unicure India Ltd., C-21, 22 & 23, Sectore-3, Noida-201301, Distt. Gautam Budh Nagar (U.P.). 12. CANDIZOLE 15 GM B. No.: 08016, Test for 2- CDSCO, West CDTL, (Clotrimazole Cream Mfg dt: 01/2018, Chlorotitanol Zone, Mumbai Mumbai IP) Exp dt: 12/2019,Mfd by: M/s. ION healthcare Pvt. Ltd., Baddi Barotiwala Road, Baddi, Dist, Solan, H.P. 173205. 13. Paracetamol Tablets B. No.: T-1805009, Assay, CDSCO, West CDTL, I.P. 500 mg (relieve Mfg dt: 05/2018, Dissolution & Zone, Mumbai Mumbai Tablets) Exp dt: 04/2020, Uniformity of Mfd by: M/s. Jeoffrey Weight Laboratories, Village Harbanspura, G.T. Road, Sirhind, Distt. Fatehgarh Sahib (P.B.) 140406. 14. Atenolol & B. No.: 707470, Assay of CDSCO, Sub CDTL, Amlodipine Tablets Mfg dt: 10/2017, Amlodipine Zone, Indore Mumbai Exp dt: 09/2019, Mfd by: M/s. Ciron Drugs & Pharmaceuticals Pvt. Ltd., Plot No. 35 to 37, 43 to 45, CFCB, Dewan Udyog Nagar Aliyali, Palghar, Dist. Palghar-401404. 15. B-29 (Alpha Lipoic B. No.: CG18094, Disintegration CDSCO, West CDTL, Acid, Folic Acid, Mfg dt: 05/2018, Time Zone, Mumbai Mumbai Methylcobalamin Exp dt: 04/2020, Pyidoxine Mfd by: M/s. Corona Hydrochloride & Remedies Pvt. Ltd., Village Vitamin D3 Tablets) Jatoli, Post Office-Oachghat, Tehsil-Solan, Dist. Solan( HP)- 173223. 16. Enalapril Maleate B. No.: T-15884, Dissolution CDSCO, N.Z., RDTL, Tablets IP 2.5 mg Mfg dt: 01/2018, (Enalapril GZB Chandigarh (ENARIL-2.5 Exp dt: 12/2019, Maleate) and TABLETS) Mfd by: M/s. Jackson Assay of Enalapril Laboratories Pvt. Ltd., Maleate Bye Pass, Majitha Road, Amritsar-143001. 17. RAMIPRIL B. No.: HRPT17003, Assay of Ramipril CDSCO, N.Z., RDTL, TABLETS IP 5 MG Mfg dt: 08/2017, GZB Chandigarh Exp dt: 07/2019, Mfd by: M/s. RAVIAN LIFE SCIENCE PVT. LTD., Plot No.34, Sector-8A, IIE, SIDCUL, Haridwar-249403, Uttarakhand, INDIA.18. CHLORZOXAZONE, B. No.: PA0048, Disintegration NCT, RDTL, DICLOFENAC Mfg dt: 01/2018, Test Delhi, Chandigarh POTASSIUM and Exp dt: 12/2019, PARACETAMOL Mfd by: M/s. Tablets (MYOSPAZ G.S.PHARMBUTOR FORTE TABLETS) PVT.LTD., PLOT NO.58, 59, 66 & 67, SECTOR-3, I.I.E., PANTNAGAR, RUDRAPUR- 263153, DIST UDHAM SING NAGAR UTTARAKHAND, INDIA. 19. LEVOCETIRIZINE B. No.: SHT7550, Dissolution CDSCO, N.Z., RDTL, HYDROCHLORIDE Mfg dt: 12/2017, (Levocetirizine GZB Chandigarh TABLETS IP 5 MG Exp dt: 11/2020, Hydrochloride) Mfd by: M/s. SYNCOM Healthcare Limited, D -42, IIE, SIDCUL, Selaqui, Dehradun- 248197, Uttarakhand. 20. LEVOCETIRIZINE B. No.: SHT7549, Dissolution CDSCO, N.Z., RDTL, HYDROCHLORIDE Mfg dt: 12/2017, (Levocetirizine GZB Chandigarh TABLETS IP 5 MG Exp dt: 11/2020, Hydrochloride) Mfd by: M/s. SYNCOM Healthcare Limited, DD-42, IIE, Sidcul, Selaqui, Dehradun- 248197, Uttarakhand. 21. DICLOFENAC B. No.: DFT 17021, Disintegration CDSCO, N.Z., RDTL, SODIUM TABLETS Mfg dt: 11/2017, Test GZB Chandigarh IP 50 MG Exp dt: 10/2019, Mfd by: M/s. VIVEK PHARMACHEM (INDIA) LTD., NH-8, Chimanpura, Amer-303102. 22. CEFTAZIDIME B. No.: A198003A, Identification for Bemina, RDTL, INJECTION IP Mfg dt: 04/2018, Ceftazidime Srinagar. Chandigarh Exp dt: 03/2020, Mfd by: M/s. ANG Lifesciences India Ltd., Village Kishanpura, Nalagarh Road, Tehsil Baddi, Distt.Solan, H.P.174101 23. Ferrous Ascorbate, B. No.: ALC-695, Assay of Ferrous CDSCO, RDTL, Zinc and Folic Acid Mfg dt: 07/2017, Ascorbate and Sub Zone, Chandigarh Tablets (ALFEE-F Exp dt: 06/2019, Folic Acid Baddi. Mfd by: M/s. Alice Healthcare, TABLETS) 81-C/2, EPIP-I, Jharmajri, Baddi, Distt.Solan (H.P.)24. Syrup of Iron and B. No.: HXF-1801, Assay of Iron (III) H.Q., RDTL, Folic Acid in a Mfg dt: 07/2018, Hydroxide Himachal Chandigarh flavoured base Exp dt: 12/2019, Polymaltose Pradesh Mfd by: M/s. NDH (HEXX FORTE Complex Pharmaceuticals Pvt.Ltd., SYRUP) calculated as Village Kishanpura, Paonta Elemental Iron Sahib-173025 (H.P.) and Folic Acid 25. DICLOFENAC B. No.: T7051, Dissolution NCT, RDTL, PROLONGED Mfg dt: 03/2017, Delhi Chandigarh RELEASE Exp dt: 02/2019, Mfd by: M/s. Zest Pharma. TABLETS IP Plot No.275, Sector ‘F’ Sanwar Road, Indore-452015 26. OMEPRAZOLE B. No.: CML-18128, Dissolution Drugs Control RDTL, CAPSULES I.P. Mfg dt: 05/2018, Department Guwahati (Omefine-20) Exp dt: 04/2020, Tripura Mfd by: M/s. Prochem Pharmaceuticals (P) Ltd. 140- 141, Makkanpur, Bhagwanpur, Roorkee, Dist-Haridwar, Uttarakhand-247661. 27. OMEPRAZOLE B. No.: CML-18056, Dissolution Drugs Control RDTL, CAPSULES I.P. Mfg dt: 03/2018, Department Guwahati Exp dt: 02/2020, (Omefine-20) Tripura Mfd by: M/s. Prochem Pharmaceuticals (P) Ltd. 140- 141, Makkanpur, Bhagwanpur, Roorkee, Dist-Haridwar, Uttarakhand-247661. 28. Diclofenac Sodium, B. No.: PGT041562, Disintegration Drugs Control RDTL, Paracetamol & Mfg dt: 10/2015, Department Guwahati Exp dt: 09/2019, Chlorzoxazone Assam Mfd by: M/s.Acme Tablets (Powergesic) Lifesciences Village Katha, Baddi Ind. Area, Tehsil, Nalagarh, Dist-Solan, H.P.- 173205.

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