NSQ ALERT FOR THE MONTH OF JANUARY-2025

NOT OF STANDARD QUALITY (NSQ) ALERT FOR THE MONTH OF JANUARY-2025 As part of the continuous regulatory surveillance, drug samples are picked from sales/distribution point, analyzed and list of Not of Standard Quality (NSQ) drugs are displayed on CDSCO portal on monthly basis. The purpose of displaying the NSQ list is to make stakeholders aware about the NSQ batches identified in the market. A. CDSCO/Central Laboratories S.No Product/Drug Batch No. Manufacturing Expiry Manufactured By NSQ Result Reported by Name Date Date CDSCO Laboratory 1. Monopropylene 9971702044 04/2024 04/2026 M/s. Shell Eastern Water CDL, Kolkata Glycol USP Chemicals, the Metropolis Tower 1, 9, North Buona Vista Drive#0701, Singapore-138588 2. Ticagrelor MT230087 11/2023 10/2026 M/s. MONIQUE Dissolution CDL, Kolkata Tablets IP 90 PHARMACEUTICAL mg (Tigamon S PVT. LTD., Plot 90) No-676, Sector-69, IMT, Faridabad, Haryana-121004 3. Calcium EZF-1989 07/2024 12/2026 M/s. Overseas Assay/content CDL, Kolkata Aspartate, Healthcare Pvt. Ltd., of 'Calcitriol' and Calcium 335 Km Milestone, 'Zinc' Orotate, National Highway Calcitriol, No.1, P.O. Box-25, Minerals And Phillaur-144410 (Pb) Vitamins Tablets 4. Diclofenac SNDA23801 08/2023 07/2025 M/s. Srinija pH CDL, Kolkata Sodium Parenterals, D.No. Injection I.P 283, Doctors Estate, (DEPAIN-75) Perecherla 522 0095. Iron Sucrose 24RS04 01/2024 12/2025 M/s. SAI Parenterals pH CDL, Kolkata Injection USP Limited, D1 & D4, 100mg/5ml Survey No.280, Phase-V, IDA, Jeedimetla, Hyderabad- 500055.TS 6. Iron Sucrose 24RS08 02/2024 01/2026 M/s. SAI Parenterals pH CDL, Kolkata Injection USP Limited, D1 &D4, 100mg/5ml Survey No.280, Phase-V, IDA, Jeedimetla, Hyderabad- 500055.TS 7. Tramadol RP-04 07/2023 06/2025 M/s. Bio Medica 'Acidity or CDL, Kolkata Hydrochloride Laboratories Pvt. Alkalinity' and Injection 50 Ltd., 254, Sector-F, 'Assay of mg/ml Sanwer Road, Tramadol' (Tramacop ) Industrial Area, Indore-452015 8. Metformin C21D93400 06/2024 05/2027 M/s. Concept Dissolution CDL, Kolkata Hydrochloride 3 Pharmaceuticals Ltd., Sustained A-28/3, MIDC, Release Tablets Chikalthana, I.P. 500mg Aurangabad-431006 (Conmet SR- 500) 9. Cefuroxime 4617001 05/2024 04/2026 M/s. Bengal Dissolution CDL, Kolkata Axetil Tablets IP Chemicals and 500 mg Pharmaceuticals Ltd., 164, Maniktala Main Road, Kolkata-700 054 10. Cefixime & CT5853A 03/2024 02/2026 M/s. Assay of CDL, Kolkata Ofloxacin J.M.LABORATORIES Cefixime Tablets Village-Bhanat, P.O.- Ghatti, Subathu(CEPHAFLU- Road, Solan (HP)- 400) 173211 11. Ambroxol HCL, HBD 2403 04/2024 03/2026 M/s. HIPPO LABS Description CDL, Kolkata Levosalbutamol PVT. LTD, Plot No- sulphate and 17, R. G. Nagar, Guaiphenesin IDA, Prashanthi Drops (Breath- Nagar, Kukatpally, LS Drops ) Hyderabad-72 12. Ofloxacin ED4648 11/2024 10/2026 M/s. Captab Biotec, Assay of CDL, Kolkata Ophthanmic Unit-II, Plot No. 125, Ofloxacin Solution IP E.P.I.P. Road, Mauja, (Ocuex Eye Jharmajri, Baddi, Drops) Dist. Solan (H.P.)- 173205 13. Gentamicin GM-19 04/2024 03/2026 M/s. New Lab SPURIOUS C D L , K o l k a t a Injection I.P. 30 Industry, Ramnagar, Particulate ml Kurthoul, Patna Matter, Extractable Volume, Composition of Gentamicin Sulphate, Identification and Assay of Gentamicin Sulphate and Description 14. Non-Sterile Not BT229 07/2024 06/2025 M/s. Bio Tech Appearance of CDL, Kolkata for Intravenous Formulation, Block A- solution, assay Administration 10, Plot No-136, of sodium, Concentrated D.No. 17-65, potassium, Acidic Solution Penamaluru Mandal, calcium, New Autonagar, magnesium and Kanuru, Vijayawada- total chloride. 520007 Particulate contamination and description15. Clobazam TPT-012058 01/2024 12/2026 M/s. Tanpal Dissolution CDL, Kolkata Tablets IP 5 mg Pharmaceuticals, D- 12-13, Focal Point, Nabha-147 201 16. Vitamin B- 1724-226 05/2024 10/2025 M/s. ZEE Assay of CDL, Kolkata Complex with LABORATORIES 'Cyanocobalami Vitamin C and LTD., Behind 47, n' and 'Calcium Zinc Capsules Industrial Area, Pantothenate' (Nutribest-Plus ) Paonta Sahib-173025 17. Metoclopramide 4EC038092 08/2024 07/2027 M/s. Ciron Drugs & Description and CDL, Kolkata Injection BP Pharmaceuticals Pvt. Particulate Ltd., N-118/119, Contamination M.I.D.C., Tarapur, Boisar, Dist-Palghar- 401506 18. Sodium ACF24159 11/2024 10/2026 M/s. Safe Parenterals Description, CDL, Kolkata Chloride and Pvt. Ltd. Gollapadu Appearance of Glycerine Sterile 522408, Palnadu solution and Diluent for fowl Dist, Andhra Particulate pox vaccine and Pradesh, India matter its combinations for wing web application 19. Rabeprazole MD23H13 08/2023 07/2025 M/s. Martin & Brown pH, Water, CDL, Kolkata Sodium Bio-Sciences Pvt. Clarity of Injection I.P. Ltd., K. No. 918/419, Solution, Malkumajra, Particulate Nalagarh Road, matter and Baddi, Dist- Solan Assay of (H.P.)-173205 Rabeprazole Sodium 20. Ofloxacin & SCZAG230 06/2023 11/2025 M/s. Sano-Cito Dissolution CDL, Kolkata Ornidazole 07 Therapeutics Inc., Tablets IP Vill. Loharan, P.O. (Zeof-O) Ghatti, Solan-173211 (H.P.)21. Calcium CG-386 03/2024 02/2026 M/s. Rathi pH, Particulate CDL, Kolkata Gluconate Laboratories(Hindust matter, Sterility Injection I.P. an) Pvt. Ltd., and Description 10% w/v Industrial Area, (REOCAL) Patna-800013 22. Dexamethasone DX-18 04/2024 03/2026 M/s. New Lab SPURIOUS CDL, Kolkata Sodium Industry, Ramnagar, pH, Extractable Phosphate Kurthoul, Patna volume, Injection Particulate (Dexamethason matter, Sterility, e 30ml) Identification and Assay of Dexamethasone Sodium Phosphate and Description 23. Dmex 4D077301 09/2023 08/2026 M/s. 4Care Assay of CDL, Kolkata Colecalciferol Lifescience Pvt. Ltd. Cholecalciferol (Vitamin D3) Survey No. 23/3P & Tablets B.P. 24, Opp. Jeans Factory, Daduram Vistar, Village- Bagdol, Tal. Kathlal, Dist. Kheda-387630, Gujarat, India 24. Rabeprazole LC-6943 01/2024 12/2025 Lifevision Healthcare, Dissolution RDTL, Guwahati Sodium 20mg Plot No. 140-141, (EC) & E.P.I.P., Phase-1, Domperidone Jharmajri, Baddi, 10mg (IR), Distt. Solan (H.P.) Domperidone 174 103 20mg (SR) Capsules (Rebast-ARD) 25. Montelukast & VLB-GT- 09/2023 08/2025 Vee Laboratories,, Dissolution RDTL, Guwahati Levocetirizine 2219 Village-Kalier, Hydrochloride Subathu, Road-Tablets IP Saproon (Post Office) (SOLIKAST-L) Solan-173211, Himachal Pradesh 26. Zinc Sulphate LMT240811 07/2024 06/2026 Life Max Cancer Uniformity of RDTL, Guwahati Dispersible Laboratories, Plot No. dispersion & Tablets IP 20 106 & 106 A, Disintegration mg Sector6A, IIE, SIDCUL, Haridwar249403 (U.K) 27. Nimesulide & T-24004 04/2024 03/2026 Kshipra Drugs Pvt. Disintegration RDTL, Guwahati Paracetamol Ltd., 40- 41/22-B, Tablets Industrial Area, No. 1, (SOMOO) Dewas (M.P.)- 455001 28. Fexofenadine UGT231163 08/2023 07/2025 Unimarck Healthcare Dissolution RDTL, Guwahati Hydrochloride Ltd., Plot No.: 24, 25 Tablets I.P. 120 & 37 Sector 6A, mg. SIDCUL, Haridwar - 249403 (Uttarakhand) 29. HYPODERMIC 2407154 07/2024 06/2029 NUBENO Sterility RDTL, Guwahati SYRINGE WITH HEALTHCARE NEEDLE PRIVATE LIMITED, (Nusafe 2ml) Plot No. 10A, Sector23, Mihan Nagpur- 441108 30. Rabeprazole RTD.23010 08/2023 07/2025 M/s Cartel Assay of RDTL, Guwahati Sodium (as 5 Laboratories, 10/A, Rabeprazole enteric coated) 11/A, Chengicherla, Sodium & Domperidone Medchal-Malkajgiri (As Sustained (Dist.), Hyderabad-92 Release) Capsules (Rabito-DSR) 31. Losartan LMT240826 07/2024 06/2026 Life Max Cancer Dissolution RDTL, Guwahati Tablets IP 50 Laboratories, Plot No. mg 106 & 106 A, Sector6A, IIE, SIDCUL, Haridwar249403 (U.K) 32. Albendazole T-3159 01/2024 12/2025 Jackson Laboratories Dissolution RDTL, Guwahati Tablets IP 400 Pvt.Ltd, 22-24, mg Majitha Road, Bye (Albendazole Pass, Amritsar-143 400) 001(India) 33. Itraconazole CTA-01 02/2024 01/2026 Agron Remedies Pvt. Dissolution RDTL, Guwahati Capsules IP 100 Ltd., Sarverkhera, mg Moradabad Road, Kashipur-244713 (Uttarakhand) 34. Diclofenac A-1694 02/2024 01/2026 ALCHEMIST pH , Sterility, RDTL, Guwahati Sodium REMEDIES PVT. Particulate Injection IP (AL- LTD., 133-139, Matter, and DICLO) Industrial Estate, Assay At13, Road, Dewas 35. Calcium 500 mg LMT240431 04/2024 03/2026 Life Max Cancer Identification RDTL, Guwahati with Vitamin D3 Laboratories, Plot No. and Assay of 250 IU Tablets 106 & 106 A, Vitamin D3 and IP Sector6A, IIE, Dissolution of SIDCUL, Calcium Haridwar249403 (U.K) 36. Levocetirizine ZT23547C 11/2024 10/2025 M/s Zenon Dissolution of RDTL, Guwahati Hydrochloride & Lifesciences Pvt. Ltd., Montelukast Montelukast Survey-no. 343/P, Sodium Tablets Bavla Sanand IP (Montura-L) Highway, Modasar, Ahmedabad, Gujarat, INDIA 382220 37. Paracetamol ZA23019 07/2023 06/2026 Brussels Laboratories Assay of CDTL-Mumbai Oral Pvt. Ltd., 33, Paracetamol Suspension BP Changodar Ind. (100 ml) 120 Estate, Sarkhej Bavla mg/ 5 ml Road, ChangodarAhmedabad - 382 210, (Gujarat) 38. Amlodipine CT062 08/2024 07/2026 Ryzer Related CDTL-Mumbai Tablets IP 5 mg Pharmaceutical Pvt. substances (Systogan-5) Ltd., Plot No. 901, Dholakuva, Mansa, Gandhinagar, Gujarat- 382845. 39. Lorazepam 06P23T03 08/2023 04/2027 Shine Assay CDTL-Mumbai Tablets IP 1 mg Pharmaceuticals (PROLINE - 1) Limited., Plot No. 132, Karjan-Vermardi Road, Juni Jitherdi, Ta. Karjan- 391240, Dist : Vadodara, (Gujarat) 40. Itraconazole AFC - 102 05/2024 04/2026 APEX Dissolution CDTL-Mumbai Capsules (Trax FORMULATIONS - 200) PVT. LTD., 1276, Rajpur Ahmedabad- Mehsana Highway, Dist. Mehsana, Gujarat. 41. Enteric Coated AFC - 111 08/2024 07/2026 APEX Dissolution for CDTL-Mumbai Rabeprazole FORMULATIONS Domperidone Sodium And PVT. LTD., 1276, Domperidone Rajpur Ahmedabad- Sustained Mehsana Highway, Release Dist. Mehsana, Capsules Gujarat. (Dorab SR Capsules) 42. Aceclofenac T042304 11/2023 04/2025 Bengal Chemicals & Related CDTL-Mumbai Tablets IP 100 Pharmaceuticals Ltd., substances and mg (A Govt. of India Assay of Enterprise) at 11, AceclofenacW.E.A. Faridabad - 121001 (Haryana) 43. Montelukast 18RT2401 04/2024 09/2026 Adnova Healthcare Description and CDTL - Indore Sodium and Pvt. Ltd. 156, 157 A, Uniformity of Levocetirizine Siddhi Industrial dispersion Hydrochloride Infrastructure Park, Dispersible Waghodia, Vadodara Tablets - 391760, Gujarat (ROMILAST® L 4) 44. Metoprolol DT 2403 10/2026 09/2027 M/s. Triveni Dissolution CDTL, Hyderabad Succinate Formulations Limited, Prolonged Plot No.52, 53, 54 Release Tablets ALEAP Industrial IP 25 mg Estate, Surampalli- 521212 45. Ciprofloxacin LV4210 03/2024 02/2026 Captab Biotec, Unit- In test of Lactic RDTL, Chandigarh Injection IP II, Plot No. 125, Acid per mg of E.P.I.P.Road, Mauja, Ciprofloxacin Jharmajri, Baddi, Distt. Solan (H.P.)- 1732025 46. Ceftriaxone SRIJ240041 10/2024 09/2026 SYSTOLE Particulate RDTL, Chandigarh Injection IP REMEDIES PVT. matter (Cefiglad-1 LTD., Vill. Ogli, Kala Injection) Amb. Teh. Nahan, Distt. Sirmour (H.P.)- 173030 47. Cefixime and BT-240511 05/2024 04/2026 A.N.D. Assay of Lactic RDTL, Chandigarh Lactic Acid HEALTHCARE LTD, Acid Bacillus Bacillus Tablets Plot No. C-24, Focal (CEFIZOC-200 Point, Kurali, Mohali- LB TABLETS) 140103 48. Hyoscine PT-102441 10/2024 09/2026 Primus Assay of RDTL, Chandigarh Butylbromide Pharmaceuticals, Hyoscine Tablets IP Sadhoura Road, Butylbromide Mouza Ogli Khari Vill(BUSCOPRIME Asgarpur Majra, Kala -10 TABLETS) Amb, Dist. Sirmour- (H.P.) 173030 49. Ambroxol HCl, BALS-2005 11/2023 10/2025 Wings Novitas Assay of RDTL, Chandigarh Guaiphenesin, Healthcare LLP,, 43 Ambroxol Terbutaline & 44, HPSIDC, Hydrochloride Sulphate and Industrial Area, and Terbutaline Menthol Syrup Baddi-173205 (H.P.) Sulphate (BRONKOREX AM Syrup) 50. Ramipril Tablets TPT- 10-2024 09-2026 Tanpal Assay of RDTL, Chandigarh IP 5 mg 0102040 Pharmaceuticals, D- Ramipril 12-13, Focal Point, Nabha-147201 51. Pyridoxine TPT- 10-2024 09-2026 Tanpal Assay of RDTL, Chandigarh Tablets IP 10 0102064 Pharmaceuticals, D- Pyridoxine mg (Pyrotan-10) 12-13, Focal Point, Nabha-147201 52. Aceclofenac, NBT- 11/2024 10/2026 Soft Touch Assay of RDTL, Chandigarh Paracetamol 240624 Pharmaceuticals Aceclofenac and India Lt., Plot No. 8, and Serratiopeptidas Industrial Area, Paracetamol e Tablets (ST- Waknaghat, Distt. SP Tablets) Solan (H.P.)-173234 Not of Standard Quality (NSQ) drugs: The drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs. (Further, the term ‘standards of quality’ is defined under the Section 16 (1) (a) of Drugs & Cosmetics Act, 1940, that the ‘standards of quality’ mean that the drug complies with the standards set out in the Second Schedule of the said Act.)