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Date: 2024-07-19 Category: Not Applicable State: Union Government Country: India

NSQ ALERT FOR THE MONTH OF JUNE 2024

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 is a 'Not of Standard Quality' (NSQ) alert for drugs and products identified in June 2024. It lists specific drugs/products, their manufacturers, batch numbers, and the reasons for being declared NSQ, as determined by CDSCO (Central Drugs Standard Control Organisation) laboratories and Regional Drugs Testing Laboratories (RDTL).

Key Changes

  • A total of 31 products are listed as Not of Standard Quality (NSQ).
  • The products include various drugs like Propylene Glycol, Compound Sodium Lactate Injection, Esomeprazole Tablets, Gentamicin Sulphate Injection, Frusemide Injection, Ceftriaxone for Injection, Amoxycillin & Potassium Clavulanate Injection, Cefixime & Ofloxacin Tablets, Ranitidine Hydrochloride Tablets, Glipizide and Metformin Tablets, Dextromethorphan Hydrobromide combination cough syrup, Etamsylate Tablets, Tranexamic Acid Tablets, Iron & Folic Acid Syrup, Prednisolone Tablets, Fexofenadine Hydrochloride Tablets, Norfloxacin Oral Suspension, Albendazole Tablets, Pantoprazole Gastro-Resistant Tablets, Co-trimoxazole Tablets, Montelukast Sodium and Levocetirizine Hydrochloride Tablets, Levocetirizine Dihydrochloride and Montelukast Sodium Tablets, Iron and Folic Acid Syrup, Etoricoxib Tablets, and Mannitol Injection.
  • Also included are products like Aloevera, Glycerin and Vitamin-E Soap, and Propylene Glycol USP.
  • The reasons for NSQ include issues such as Relative Density, Bacterial Endotoxins, Dissolution, Description & Particulate matter, pH, Clarity of Solution, Assay of Potassium Clavulanate, Assay of Cefixime Trihydrate & Ofloxacin, Specific Gravity, Description, Dissolution of Glipizide, pH, Related Substances, Assay of Phenylephrine Hydrochloride, Assay of Folic Acid, Assay of Prednisolone, Matter insoluble in alcohol, Dissolution (In 10 minutes) and (in 30 minutes), Description and Total Fungal Count, Test for Sterility.
  • The products were tested by various CDSCO laboratories including CDL Kolkata, CDTL Mumbai, CDTL Hyderabad, RDTL Chandigarh, and RDTL Guwahati.

Impact Analysis

Manufacturers

  • Action Item: Conduct a thorough investigation into the root cause of the quality defects. Implement corrective and preventive actions (CAPA) to prevent recurrence. Engage with CDSCO to address their concerns and demonstrate commitment to quality.

Distributors/Suppliers

  • Action Item: Review inventory and quarantine affected batches. Communicate with retailers and healthcare providers about the recall. Strengthen quality control processes for incoming goods.

Retailers/Pharmacies

  • Action Item: Remove affected products from sale. Display recall notices prominently. Provide refunds or replacements to customers who return the products.

Consumers/Patients

  • Action Item: If consumers have any of the listed products, they should consult with a healthcare professional and return the product to the pharmacy. Report any adverse events to the appropriate regulatory authority.

Regulatory Authorities (CDSCO)

  • Action Item: Conduct follow-up inspections of the manufacturing facilities. Impose penalties on non-compliant manufacturers. Enhance collaboration with state drug control authorities.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. CDL, Kolkata: Central Drugs Laboratory, Kolkata, a CDSCO laboratory. CDTL, Mumbai: Central Drugs Testing Laboratory, Mumbai, a CDSCO laboratory. RDTL Chandigarh: Regional Drugs Testing Laboratory, Chandigarh. RDTL, Guwahati: Regional Drugs Testing Laboratory, Guwahati. IP: Indian Pharmacopoeia USP: United States Pharmacopeia
Official Source Record View Original Source →
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NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF JUNE – 2024. A. CDSCO/Central Laboratories S.No Product/Drug Batch No. Manufacturing Expiry Manufactured By NSQ Result Reported by Name Date Date CDSCO Laboratory 1. Propylene PG- 11/2023 10/2028 M/s. Manali Relative CDL, Kolkata Glycol I.P. IP/2023- Petrochemicals Ltd., Density 24/2355 Manali, Chennai- 600068, India 2. Propylene BT1205B0 07/2023 07/2024 M/s. Balaji Amines Relative CDL, Kolkata Glycol USP/IP 4072023 Limited, Plot No. F- Density 104, Chinchoili M.I.D.C., Tq. Mohol, Distt. Solapur - 413 255, Maharastra 3. Compound P2401050 01/2024 12/2025 M/s. Vision Parenteral Bacterial CDL, Kolkata Sodium Lactate 08 Pvt. Ltd., A-2-44, 45, endotoxins Injection I.P., Sector-15, GIDA 500 ml (Ringer Industrial Area, Lactate Solution Gorakhpur -273209 for Injection) (U.P.), India 4. Esomeprazole GD23083 07/2023 06/2025 M/s. GlenSmith Labs Dissolution CDL, Kolkata Gastro- Private Limited, Mfg. Resistant by: Skymap Tablets IP 40 Pharmaceuticals Pvt. mg (Esomedge- Ltd., B-3, Dev Bhoomi 40) Industrial Estate, Puhana Iqbalpur Road, Roorkee 247 667.5. Gentamicin 323-216 03/2023 02/2025 M/s. Zee Laboratories Description & CDL, Kolkata Sulphate Ltd., Behind 47, Indl. Particulate Injection I.P. 2 Area, Paonta Sahib - matter ml 173025 6. Frusemide FRA12347 12/2023 11/2025 M/s. Nandani Medical pH CDL, Kolkata Injection IP 2 ml Laboratories Pvt. Ltd., (FRUSEMIDE) 221/5, Bicholi Hapsi, Kanadia Road, Indore 7. Ceftriaxone for DC30119 10/2023 09/2025 M/s. Captab Biotec Particulate CDL, Kolkata Injection I.P. 1 Unit-II, Plot No-125, matter gm E.P.I.P Road, Mauja Jharmajri, Baddi, Distt.-Solan H.P. 8. Amoxycillin & 23AP04 05/2023 04/2025 M/s. Sai Parenterals Clarity of CDL, Kolkata Potassium Limited, D1 & D4, Solution and Clavulanate Survey No. 280, Assay of Injection IP 1.2 Phase- V, IDA, Potassium gm Jeedimetla, Clavulanate Hyderabad-500 055, TS. 9. Cefixime & DB230057 02/2023 01/2025 M/s. Daxin Assay of CDL, Kolkata Ofloxacin Pharmaceuticals Pvt. Cefixime Tablets Ltd., Plot No-121-122, Trihydrate & (CEFIKAM OF EPIP, Jharmajri Assay 200) Phase-1, Teh. Baddi, Ofloxacin Distt. Solan (H.P.) 174 103. 10. Propylene 97220141 11/2023 10/2028 M/s. Shell Eastern Specific CDL, Kolkata Glycol USP 13 Chemicals, The Gravity Metropolis Tower, 1, 9 North Buona, VislaDrive 07 01 Singapore 138588 11. Ranitidine GTDE3019 05/2023 04/2025 M/s. Francis Remdies Description CDL, Kolkata Hydrochloride (India) Pvt.Ltd., Vill- Tablets Mandawali, Roorkee, (Ranylaj-150) Distt. Haridwar (U.K.) 247670 12. Glipizide and 04010026 11/2023 04/2025 M/s. USV Private Dissolution of CDL, Kolkata Metformin Limited, At: B-249/B- Glipizide Tablets IP 250, II Stage, Peenya (Glynase-MF) Industrial Estate, Bangalore-560058 13. Exo Cheri L/040618 04/2024 01/2026 Exotic Pharma, 91/1, pH CDTL-Mumbai (Dextromethorp G.I.D.C., GODHRA han Dist.- Panchmahal, Hydrobromide Gujarat- 389001 Chlorpheniramin e Maleate Pheylephrine Hydrochloride Cough Syrup) 14. Etamsylat ELT1104 02/2024 07/2024 Unicure India Ltd., C- Description CDTL-Mumbai Tablets 500 mg 21, 22 & 23, Sector-3, Noida-201 301, Distt. Gautam Budh Nagar (U.P) 15. Tranexamic GT31022 01/2024 12/2025 OMEGA PHARMA Related CDTL-Mumbai Acid Tablets I.P. KhasraNo.-482, substances 500 mg Village-Saliyar, Roorkee-247667, Distt.-Haridwar (Uttarakhand)16. Extuss-D 2402168 02/2024 01/2026 Brij Healthcare Pvt. Assay of CDTL-Mumbai (Dextromethorp Ltd., 51/10, G.I.D.C Phenylephrin han HBR, Estate, Motipura, e Chlorpheniramin Himatnagar, Gujarat Hydrochloride e Maleate & 383001 Phenylephrine HCL Syrup) 17. IRON & FOLIC RIFS-209 04/2024 09/2026 M/s. Revat pH and CDTL, Hyderabad ACID SYRUP IP Laboratories Pvt. Ltd., Assay of Works at : 12-321, Folic Acid Opp. I.D.A, Kurnool Road, Pernamitta, Ongole-523002 18. Prednisolone PRDT- 11/2024 10/2024 WINGS BIOTECH Assay of RDTL Chandigarh Tablets IP 10 1007 LLP, 43 & 44, Prednisolone mg HPSIDC, Industrial Area, Baddi-173205 (H.P.) 19. Aloevera, COS-130 03/2024 02/2026 Samanyu Skin Care, Matter RDTL Chandigarh Glycerin and Plot No. 191, HPSIDC, insoluble in Vitamin-E Soap Baddi, Distt. Solan alochol (D-Soft Soap) (H.P.)-1732025 20. Aloevera, COS-132 03/2024 02/2026 Samanyu Skin Care, Matter RDTL Chandigarh Glycerin, Plot No. 191, HPSIDC, insoluble in Vitamin-E and Baddi, Distt. Solan alochol Jojoba oil (H.P.)-1732025 (Synmoist Soap) 21. Aloevera+Glyce COS-131 03/2024 02/2026 Samanyu Skin Care, Matter RDTL Chandigarh rin+Almond Oil Plot No. 191, HPSIDC, insoluble in and Vitamin-E Baddi, Distt. Solan alochol (H.P.)-1732025Soap (Aqualux Soap) 22. Fexofenadine CT232407 08/2023 07/2025 CMG BIOTECH PVT. Dissolution RDTL Chandigarh Hydrochloride 15A LTD., (Unit-II) Plot No. (In 10 Tablets IP 58, Phase III, Industrial minutes) and (MANOFEX-180 Area, Sansarpur (in 30 TABLETS) Terrac HP-176501 minutes) 23. Norfloxacin Oral RL230022 03/2023 02/2025 RIDLEY LIFE Description RDTL Chandigarh Suspension SCIENCE PVT. LTD., and Total (Ridnor Unit II : D-1566 Fungal Count Suspension) DSIDC, Ind. Complex, Narela, Delhi-110040 24. Albendazole MS1AO22 07/2022 06/2025 MAXTAR BIO- Dissolution RDTL Chandigarh Tablets IP 01 GENICS, Khasra No. 705, Vill. Malku Majra, Nalagarh Road, Baddi, Distt.Solan-173205 (H.P.)-India 25. Pantoprazole PGR-07 01/2024 12/2025 Agron Remedies Pvt. Dissolution RDTL, Guwahati Gastro- Ltd., Sarverkhera, Resistant Moradabad Road, Tablets IP 40 Kashipur-244713 mg. (Uttarakhand) 26. Co-trimoxazole ST-223 06/2023 05/2025 High Tech Pharma, 49, Dissolution RDTL, Guwahati Tablets IP (S- Khandelwal (Trimethopri tron Tablets SS) compound, Palda, m and Indore (MP) Sulphametho xazole) 27. Montelukast ST23- 05/2023 04/2025 M/s Symbiosis Dissolution of RDTL, Guwahati Sodium and 384D Pharmaceuticals Pvt. Montelukast Levocetirizine Ltd.,, Suketi Road, Levocetirizine Hydrochloride Kala Amb Distt. hydrochlorideTablets IP Sirmour, Himachal (Levmont) Pradesh - 173030 28. Levocetirizine 23112701 03/2023 02/2025 MERCURY Dissolution of RDTL, Guwahati Dihydrochloride LABORATORIES Montelukast and Montelukast LIMITED., Unit No.2, Sodium Tablets Halol Baroda Road, IP Village: Jarod. Tal: Waghodia, Dist: Vadodara- 391510 29. Iron and Folic IFIS23015 08/2023 01/2025 Galpha Laboratories Assay of RDTL, Guwahati Acid Syrup IP Limited, Village- Folic Acid Thana, Baddi, Himachal Pradesh- 173205 30. Etoricoxib ECX-2304 08/2023 07/2025 Apple Formulations Dissolution RDTL, Guwahati Tablets I.P. 90 Private Limited, Plot mg. No. 208, Kishanpur, Roorkee - 247667 (U.K.) 31. Mannitol M1M30038 07/2023 06/2025 Kunal Remedies Pvt. Test for RDTL, Guwahati Injection I.P. Ltd., Khasra 284, Vill. Sterility (20% w/v) Anaura Kala Faizabad Road, Lucknow 226028, (UP), India

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