CDSCO monthly lab alert

CDSCO NSQ alert, February 2020: 38 drug batches flagged

By Blacklisted editorial team· Published 20 Mar 2020· Updated 20 Sep 2026· Source: CDSCO NSQ portal

In its February 2020 alert, the Central Drugs Standard Control Organisation listed 38 drug batches that failed quality tests, 21 at central laboratories and 17 at state drug-testing laboratories, from 30 manufacturers across 31 products. The most common failure was dissolution, and the most-represented manufacturing state was Punjab. Products flagged include Pantoprazole Gastro- Resistant Tablets I.P., Pantoprazole Gastro Resistant Tablets I.P.40 mg., Albendazole 400 mg. Tablets I.P..

38
Batches flagged
21 / 17
Central / state labs
Dissolution
Top reason
30
Manufacturers

Batches per month, last 12 alerts

Mar 2019Feb 2020 · 38

Full list of NSQ batches, February 2020

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Product Batch Manufacturer Reason declared NSQ Tested by
Tymolytic AP (Aceclofenac, Paracetamol & Trypsin Chymotrypsin Capsules) LVC?6286Mfg 2018-12 · Exp 2020-11 Life Vision HealthcareHimachal Pradesh Assay of Trypsin ChymotrypsinAssay CDL KolkataCDSCO lab
Sucralfate and Oxetacaine Suspension ( SUCRACE-O SUSPENSION ) ML190359Mfg 2019-09 · Exp 2021-08 Mascot Health Series Pvt. LtdUttarakhand Assay of OxetacaineAssay RDTL ChandigarhCDSCO lab
Serratiopeptidase Tablets IP 10 mg SET8002Mfg 2017-10 · Exp 2020-09 Sai Mirra Innopharm Pvt. LtdTamil Nadu AssayAssay CDL KolkataCDSCO lab
STECLIN INJECTION Veterinary 50 mg/ml (Oxytetracycline Hydrochloride Injection I.P. 30 ml) STIR19113Mfg 2019-08 · Exp 2021-07 Zydus Animal HealthGujarat Bacterial Endotoxins TestBacterial endotoxins CDL KolkataCDSCO lab
Phenytoin Sodium Tablets I.P. 100 mg T?18909Mfg 2019-02 · Exp 2021-01 Jackson Laboratories Pvt. LtdPunjab Assay and DescriptionAssay CDL KolkataCDSCO lab
Pantoprazole Tablets I.P. (PANTA-40) OPT-48Mfg 2018-05 · Exp 2020-04 Orison Pharmaceuticals 51Haryana DissolutionDissolution RDTL GuwahatiState lab
Pantoprazole Sodium Tablets I.P. T-7105Mfg 2018-09 · Exp 2020-08 Kwality Pharmaceuticals Ltd. Nag KalanPunjab DissolutionDissolution RDTL GuwahatiState lab
Pantoprazole Gastro- Resistant Tablets I.P. T-7166Mfg 2018-10 · Exp 2020-09 Kwality Pharmaceuticals Ltd. Nag KalanPunjab DissolutionDissolution RDTL GuwahatiState lab
Pantoprazole Gastro- Resistant Tablets I.P. T-7165Mfg 2018-10 · Exp 2020-09 Kwality Pharmaceuticals Ltd. Nag KalanPunjab DissolutionDissolution RDTL GuwahatiState lab
Pantoprazole Gastro Resistant Tablets I.P.40 mg. T-7159Mfg 2018-10 · Exp 2020-09 Kwality Pharmaceuticals Ltd. Nag KalanPunjab DissolutionDissolution RDTL GuwahatiCDSCO lab
Pantoprazole Gastro Resistant Tablets I.P.40 mg. T-7156Mfg 2018-10 · Exp 2020-09 Kwality Pharmaceuticals Ltd. Nag KalanPunjab DissolutionDissolution RDTL GuwahatiState lab
Oxytetracycline Hydrochloride I.P. Y2-1904082-3Mfg 2018-04 · Exp 2022-04 Hebei Shengxue Dacheng Pharmaceuticals Co. Ltd Water ContentWater content CDL KolkataCDSCO lab
Oxytetracycline Hydrochloride (VET) IP/EP/USP Y51806089WMfg 2018-06 · Exp 2022-05 Hebei Jainmin Starch Glucose Co. Ltd Water ContentWater content CDL KolkataCDSCO lab
Ondansetron Tablet I.P. (ONDEM-4) 19440988Mfg 2019-05 · Exp 2021-04 Alkem Health Sciences Unit-2Sikkim DissolutionDissolution RDTL GuwahatiState lab
Ondansetron Injection I.P. 2 mg/ml, 2 ml ONI1923Mfg 2019-06 · Exp 2021-05 Modern LaboratoriesMadhya Pradesh Description and Particulate MatterDescription CDL KolkataCDSCO lab
Metronidazole Tablets I.P. 400mg. (NEUZOL- 400) NZL-19002Mfg 2019-05 · Exp 2022-04 Neutec Healthcare Pvt. Ltd. E-698Delhi DissolutionDissolution RDTL GuwahatiState lab
Mefenamic Acid and Dicyclomine Hydrochloride Tablets IP ( KOLISPAS TABLETS) ABM29010Mfg 2019-07 · Exp 2022-06 Psychotropics India LtdUttarakhand DescriptionDescription RDTL ChandigarhCDSCO lab
Lactulose Solution TL-19109Mfg 2019-06 · Exp 2021-05 Terrace Pharmaceuticals (P) Ltd. 3-B (a) Assay of LactuloseAssay RDTL ChandigarhCDSCO lab
Glyjack ? 1 (Glimepiride Tablets I.P.) T?19598Mfg 2019-05 · Exp 2021-04 Jackson Laboratories Pvt. LtdPunjab DissolutionDissolution CDL KolkataCDSCO lab
Fexodil 120 mg (Fexofenadine Hydrochloride Tablets) T?18839Mfg 2019-02 · Exp 2021-01 Jackson Laboratories Pvt. LtdPunjab DissolutionDissolution CDL KolkataCDSCO lab
Ferrous Sulphate and Folic Acid Tablets I.P. ELB-1901Mfg 2019-07 · Exp 2021-06 HLL Lifecare Ltd. 11/A-1 & 12/C-1Madhya Pradesh DisintegrationDisintegration RDTL GuwahatiState lab
Everolimus 201812021Mfg 2018-12 · Exp 2023-12 Zhejiang Medicines & Health Products Import & Export Co. Ltd Assay, Water and Chromatographic PurityAssay CDL KolkataCDSCO lab
Erythromycin Stearate Tablets Ip 250 Mg GT18390Mfg 2018-09 · Exp 2021-08 Globela Pharma Pvt. Ltd. 357Gujarat DissolutionDissolution RDTL ChandigarhCDSCO lab
Enzitec Digestive Enzyme Syrup UBL19005Mfg 2019-01 · Exp 2020-06 Unibiotech Formulations Delta DivisionHimachal Pradesh Identification of Diastase and Assay of PepsinAssay RDTL ChandigarhState lab
Domperidone Suspension (Dom-H) 1801Mfg 2018-03 · Exp 2020-02 Harsh Healthcare 100Madhya Pradesh AssayAssay RDTL GuwahatiState lab
Cyanocobalamin Inj. I.P. 1 ml CY2902Mfg 2019-01 · Exp 2020-12 Nandini Medical Laboratories Pvt LtdMadhya Pradesh Particulate Matter and DescriptionDescription CDL KolkataCDSCO lab
Compound Sodium Lactate Injection IP (Ringers Lactate Solution for Injection) 2194Mfg 2019-01 · Exp 2021-12 Hindustan Antibiotics Ltd PimpriMaharashtra SterilitySterility CDTL ChennaiCDSCO lab
Clindamycin Phosphate Gel Usp 1% w/w) O8073Mfg 2018-06 · Exp 2020-05 Rhydburg Pharmaceuticals Ltd. C-2 & 3Uttarakhand Assay of Clindamycin PhosphateAssay RDTL ChandigarhCDSCO lab
Cecon ? XT Tablets (Ferrous Ascorbate, Folic Acid, Vitamin B12 & Zinc Tablets) SRDT ? 1207Mfg 2019-05 · Exp 2020-10 Spas RemediseHimachal Pradesh Assay/Content of ?Folic Acid, Elemental Iron and Elemental ZincAssay CDL KolkataCDSCO lab
Biodipin 5 (Amlodipine Tablets IP) ZD19769Mfg 2019-09 · Exp 2021-08 Skymap Pharmaceuticals Pvt. LtdUttarakhand Related SubstancesRelated substances CDTL MumbaiCDSCO lab
Amoxycillin and Potassium Clavulanate Tablets IP (Angiclave- 625 Tablets) SSB-1658Mfg 2019-11 · Exp 2021-04 Shri Sai Balaji Pharmatech Pvt. Ltd. 20 Ext. HPSIDCHimachal Pradesh Identification of Clavulanic AcidIdentification RDTL ChandigarhCDSCO lab
Amoxycillin Capsules I.P. (Amoxytor-250) HCB709LMfg 2017-11 · Exp 2020-10 Himalaya Medical Pvt. LtdUttarakhand AssayAssay RDTL GuwahatiState lab
Ambroxol Hydrochloride IP AMB E18001 1219Mfg 2019-12 · Exp 2022-11 Anuh Pharma LtdMaharashtra Assay & Related SubstancesAssay CDTL MumbaiState lab
Albendazole Tablets I.P. 400mg. (Zenebend) GLL18001Mfg 2018-01 · Exp 2020-12 IBN HerbalsHimachal Pradesh DissolutionDissolution RDTL GuwahatiState lab
Albendazole Tablets I.P. 400 mg. ABT18042Mfg 2018-12 · Exp 2020-11 Vivek Pharmachem (India) Ltd. NG-8Rajasthan DissolutionDissolution RDTL GuwahatiState lab
Albendazole 400mg. Tablets I.P. BBT19329AMfg 2019-08 · Exp 2021-07 Biomax Biotechnics (P) Ltd. 261Haryana DissolutionDissolution RDTL GuwahatiState lab
Albendazole 400 mg. Tablets I.P. BBT19326AMfg 2019-08 · Exp 2021-07 Biomax Biotechnics (P) Ltd. 261Haryana DissolutionDissolution RDTL GuwahatiState lab
Albendazole 400 mg. Tablets I.P. BBT19331AMfg 2019-08 · Exp 2021-07 Biomax Biotechnics (P) Ltd. 261Haryana DissolutionDissolution RDTL GuwahatiState lab

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Changelog

  • 20 Sep 2026: table generated from the CDSCO NSQ portal export (38 rows). Revised CDSCO lists are diffed on each monthly rebuild.