CDSCO monthly lab alert

CDSCO NSQ alert, May 2021: 19 drug batches flagged

By Blacklisted editorial team· Published 20 Jun 2021· Updated 3 Nov 2026· Source: CDSCO NSQ portal

In its May 2021 alert, the Central Drugs Standard Control Organisation listed 19 drug batches that failed quality tests, 18 at central laboratories and 1 at state drug-testing laboratories, from 18 manufacturers across 19 products. The most common failure was dissolution, and the most-represented manufacturing state was Himachal Pradesh. Products flagged include Telmisartan 40 mg and Amlodipine 5 mg Tablets IP (TELMA-AM TABLETS), Sertraline Tablets IP 50 mg, Rosuvas� F-5 (Rosuvastatin and Fenofibrate Tablets I.P.).

19
Batches flagged
18 / 1
Central / state labs
Dissolution
Top reason
18
Manufacturers

Batches per month, last 12 alerts

Jun 2020May 2021 · 19

Full list of NSQ batches, May 2021

Download CSV
Product Batch Manufacturer Reason declared NSQ Tested by
Telmisartan 40 mg and Amlodipine 5 mg Tablets IP (TELMA-AM TABLETS) Batch 5201874Mfg Oct 2020 · Exp Sep 2023 Glenmark Pharmaceuticals LtdHimachal Pradesh Dissolution of AmlodipineDissolution RDTL ChandigarhState lab
Sertraline Tablets IP 50 mg Batch GM19030Mfg Sep 2019 · Exp Aug 2021 Skymap Pharmaceuticals Pvt. LtdUttarakhand DissolutionDissolution CDTL MumbaiCDSCO lab
Rosuvas� F-5 (Rosuvastatin and Fenofibrate Tablets I.P.) Batch EMU2687Mfg Sep 2019 · Exp Feb 2022 Sun Pharma Laboratories LtdSikkim Dissolution of FenofibrateDissolution CDL KolkataCDSCO lab
Rosuvas 20 (Rosuvastatin Tablets I.P.) Batch EMX0685Mfg Mar 2020 · Exp Aug 2023 Sun Pharma Laboratories LtdSikkim Dissolution & AssayAssay CDL KolkataCDSCO lab
Ramipril Tablets I.P. 2.5 mg Batch RMP-23Mfg Aug 2020 · Exp Jul 2022 C.I. LaboratoriesWest Bengal AssayAssay CDL KolkataCDSCO lab
Primaquine Phosphate I.P. 2.5 mg Batch T-22109Mfg Apr 2020 · Exp Mar 2022 Jackson Laboratories Pvt. LtdPunjab Dissolution and Assay TestAssay RDTL GuwahatiCDSCO lab
Piclin (Sodium Picosulfate Tablets 10 mg) Batch NT00061Mfg Mar 2020 · Exp Feb 2022 Medicamen Biotech LtdRajasthan Diameter, Thickness and HardnessOther CDTL MumbaiCDSCO lab
Paracetamol Tablets IP 500 mg Batch 999Mfg Mar 2019 · Exp Feb 2022 Hindustan Antibiotics LtdMaharashtra DissolutionDissolution CDTL ChennaiCDSCO lab
Pantoprazole Tablets I.P. 40 mg Batch PP22Mfg Sep 2020 · Exp Feb 2022 Suzikem Drugs Pvt. LtdTelangana DissolutionDissolution CDL KolkataCDSCO lab
Nofloxacin Tablets I.P. 400 mg Batch NT801Mfg Jul 2020 · Exp Jun 2022 Unicure India LtdUttar Pradesh DissolutionDissolution RDTL GuwahatiCDSCO lab
Nitrazepam Tablets I.P. 5 mg Batch DNIT2001Mfg Feb 2020 · Exp Jan 2022 Sunrise International Labs LtdTelangana DissolutionDissolution CDL KolkataCDSCO lab
LEDOVANC (Vancomycin Hydrochloride for Intravenous Infusion I.P. 500 mg) Batch VNI20335ACMfg Oct 2020 · Exp Sep 2022 Celon Laboratories Pvt. LtdTelangana Clarity of Solution & Appearance of SolutionOther CDL KolkataCDSCO lab
Inmecin R (Indomethacin Sustained Release Capsules U.S.P.) Batch PC-111958Mfg Nov 2019 · Exp Apr 2022 Primus PharmaceuticalsHimachal Pradesh DissolutionDissolution CDL KolkataCDSCO lab
FEXOFENADINE HYDROCHLORIDE TABLETS IP Batch FXNT-1009Mfg Nov 2020 · Exp Oct 2022 Wings Biotech LLPHimachal Pradesh DissolutionDissolution RDTL ChandigarhCDSCO lab
Diclofenac Sodium Tablets IP 50 mg Batch T2224Mfg Oct 2019 · Exp Sep 2021 Quest Laboratories Pvt. LtdMadhya Pradesh DisintegrationDisintegration CDTL MumbaiCDSCO lab
DIPHENHYDRAMINE HYDROCHLORIDE, AMMONIUM CHLORIDE, SODIUM CITRATE AND MENTHOL SRYUP Batch LX-5435Mfg Jan 2021 · Exp Jun 2022 Legen HealthcareHimachal Pradesh Assay of MentholAssay RDTL ChandigarhCDSCO lab
Clopidogrel & Aspirin Tablets Batch TACB-011Mfg Jul 2019 · Exp Jun 2021 Medipol Pharmaceutical India Pvt. LtdHimachal Pradesh Disintegration, free salicylic acid & Assay of AspirinAssay CDTL MumbaiCDSCO lab
CARDINOL-50 (Atenolol Tablets I.P. 50 mg) Batch 1091-05Mfg Feb 2020 · Exp Jan 2023 Hab Pharmaceuticals & Research LimitedUttarakhand DisintegrationDisintegration CDL KolkataCDSCO lab
Amlodipine Tablets IP (LOPIN-5 TABLETS) Batch STN-200968Mfg Jan 2021 · Exp Dec 2022 Terrace Pharmaceuticals (P) LtdHimachal Pradesh DissolutionDissolution RDTL ChandigarhCDSCO lab

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Sources

Changelog

  • 3 Nov 2026: table generated from the CDSCO NSQ portal export (19 rows). Revised CDSCO lists are diffed on each monthly rebuild.