CDSCO monthly lab alert
CDSCO NSQ alert, May 2021: 19 drug batches flagged
By Blacklisted editorial team· Published 20 Jun 2021· Updated 20 Sep 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) | 5201874Mfg 2020-10 · Exp 2023-09 | Glenmark Pharmaceuticals LtdHimachal Pradesh | Dissolution of AmlodipineDissolution | RDTL ChandigarhState lab |
| Sertraline Tablets IP 50 mg | GM19030Mfg 2019-09 · Exp 2021-08 | Skymap Pharmaceuticals Pvt. LtdUttarakhand | DissolutionDissolution | CDTL MumbaiCDSCO lab |
| Rosuvas� F-5 (Rosuvastatin and Fenofibrate Tablets I.P.) | EMU2687Mfg 2019-09 · Exp 2022-02 | Sun Pharma Laboratories LtdSikkim | Dissolution of FenofibrateDissolution | CDL KolkataCDSCO lab |
| Rosuvas 20 (Rosuvastatin Tablets I.P.) | EMX0685Mfg 2020-03 · Exp 2023-08 | Sun Pharma Laboratories LtdSikkim | Dissolution & AssayAssay | CDL KolkataCDSCO lab |
| Ramipril Tablets I.P. 2.5 mg | RMP-23Mfg 2020-08 · Exp 2022-07 | C.I. LaboratoriesWest Bengal | AssayAssay | CDL KolkataCDSCO lab |
| Primaquine Phosphate I.P. 2.5 mg | T-22109Mfg 2020-04 · Exp 2022-03 | Jackson Laboratories Pvt. LtdPunjab | Dissolution and Assay TestAssay | RDTL GuwahatiCDSCO lab |
| Piclin (Sodium Picosulfate Tablets 10 mg) | NT00061Mfg 2020-03 · Exp 2022-02 | Medicamen Biotech LtdRajasthan | Diameter, Thickness and HardnessOther | CDTL MumbaiCDSCO lab |
| Paracetamol Tablets IP 500 mg | 999Mfg 2019-03 · Exp 2022-02 | Hindustan Antibiotics LtdMaharashtra | DissolutionDissolution | CDTL ChennaiCDSCO lab |
| Pantoprazole Tablets I.P. 40 mg | PP22Mfg 2020-09 · Exp 2022-02 | Suzikem Drugs Pvt. LtdTelangana | DissolutionDissolution | CDL KolkataCDSCO lab |
| Nofloxacin Tablets I.P. 400 mg | NT801Mfg 2020-07 · Exp 2022-06 | Unicure India LtdUttar Pradesh | DissolutionDissolution | RDTL GuwahatiCDSCO lab |
| Nitrazepam Tablets I.P. 5 mg | DNIT2001Mfg 2020-02 · Exp 2022-01 | Sunrise International Labs LtdTelangana | DissolutionDissolution | CDL KolkataCDSCO lab |
| LEDOVANC (Vancomycin Hydrochloride for Intravenous Infusion I.P. 500 mg) | VNI20335ACMfg 2020-10 · Exp 2022-09 | Celon Laboratories Pvt. LtdTelangana | Clarity of Solution & Appearance of SolutionOther | CDL KolkataCDSCO lab |
| Inmecin R (Indomethacin Sustained Release Capsules U.S.P.) | PC-111958Mfg 2019-11 · Exp 2022-04 | Primus PharmaceuticalsHimachal Pradesh | DissolutionDissolution | CDL KolkataCDSCO lab |
| FEXOFENADINE HYDROCHLORIDE TABLETS IP | FXNT-1009Mfg 2020-11 · Exp 2022-10 | Wings Biotech LLPHimachal Pradesh | DissolutionDissolution | RDTL ChandigarhCDSCO lab |
| Diclofenac Sodium Tablets IP 50 mg | T2224Mfg 2019-10 · Exp 2021-09 | Quest Laboratories Pvt. LtdMadhya Pradesh | DisintegrationDisintegration | CDTL MumbaiCDSCO lab |
| DIPHENHYDRAMINE HYDROCHLORIDE, AMMONIUM CHLORIDE, SODIUM CITRATE AND MENTHOL SRYUP | LX-5435Mfg 2021-01 · Exp 2022-06 | Legen HealthcareHimachal Pradesh | Assay of MentholAssay | RDTL ChandigarhCDSCO lab |
| Clopidogrel & Aspirin Tablets | TACB-011Mfg 2019-07 · Exp 2021-06 | Medipol Pharmaceutical India Pvt. LtdHimachal Pradesh | Disintegration, free salicylic acid & Assay of AspirinAssay | CDTL MumbaiCDSCO lab |
| CARDINOL-50 (Atenolol Tablets I.P. 50 mg) | 1091-05Mfg 2020-02 · Exp 2023-01 | Hab Pharmaceuticals & Research LimitedUttarakhand | DisintegrationDisintegration | CDL KolkataCDSCO lab |
| Amlodipine Tablets IP (LOPIN-5 TABLETS) | STN-200968Mfg 2021-01 · Exp 2022-12 | Terrace Pharmaceuticals (P) LtdHimachal Pradesh | DissolutionDissolution | RDTL ChandigarhCDSCO lab |
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Official sources and primary records
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Changelog
- 20 Sep 2026: table generated from the CDSCO NSQ portal export (19 rows). Revised CDSCO lists are diffed on each monthly rebuild.