CDSCO monthly lab alert
CDSCO NSQ alert, July 2019: 18 drug batches flagged
By Blacklisted editorial team· Published 20 Aug 2019· Updated 3 Nov 2026· Source: CDSCO NSQ portal
In its July 2019 alert, the Central Drugs Standard Control Organisation listed 18 drug batches that failed quality tests, 13 at central laboratories and 5 at state drug-testing laboratories, from 15 manufacturers across 15 products. The most common failure was dissolution, and the most-represented manufacturing state was Maharashtra. Products flagged include Diclofenac Sodium Tablets I.P. 50 mg, Tolperison Hydrochloride IP, Regunac� - 50 (Diclofenac Gastro- Resistant Tablets I.P. 50 mg).
18
Batches flagged
13 / 5
Central / state labs
Dissolution
Top reason
15
Manufacturers
Batches per month, last 12 alerts
Jan 2019Jul 2019 · 18
Full list of NSQ batches, July 2019
Download CSV| Product | Batch | Manufacturer | Reason declared NSQ | Tested by |
|---|---|---|---|---|
| Tolperison Hydrochloride IP | Batch CHT019001Mfg Feb 2019 · Exp Jan 2022 | Sai Tech Pharmaceuticals Pvt. LtdMaharashtra | Test for Piperidine HydrochlorideOther | CDTL MumbaiCDSCO lab |
| Regunac� - 50 (Diclofenac Gastro- Resistant Tablets I.P. 50 mg) | Batch FZ57F801Mfg Jun 2018 · Exp May 2021 | Zim Laboratories LimitedMaharashtra | DescriptionDescription | CDL KolkataCDSCO lab |
| Prednisolone Acetate and Moxifloxacin Ophthalmic Suspension(M- Floxin-P Eye Drops) | Batch O-066Mfg Apr 2018 · Exp Mar 2020 | Oscar Remedies Pvt. LtdHaryana | Particle size and Assay of Predisolone AcetateAssay | RDTL ChandigarhState lab |
| Phenytoin Oral Suspension I.P. | Batch 8L03129Mfg Apr 2018 · Exp Mar 2020 | Ciron Drugs & Pharmaceuticals Pvt. LtdMaharashtra | AssayAssay | CDL KolkataCDSCO lab |
| Parazim 650 (Paracetamol Tablets I.P. 650 mg) | Batch FAX8A801Mfg Jan 2018 · Exp Dec 2020 | Zim Laboratories LimitedMaharashtra | DissolutionDissolution | CDL KolkataCDSCO lab |
| Paracetamol Tablets I.P. 500 mg | Batch PR1902Mfg Jan 2019 · Exp Dec 2020 | Danish Health Care (P) Ltd | DissolutionDissolution | RDTL GuwahatiState lab |
| Pantoprazole Gastro Resistant Tablets I.P. 40 mg | Batch T-7164Mfg Oct 2018 · Exp Sep 2020 | Kwality Pharmaceuticals LtdPunjab | Dissolution (Both Acid Stage & Buffer Stage)Dissolution | RDTL GuwahatiState lab |
| Multivitamin Tablets with minerals and Trace Elements (Supradyn Tablets) | Batch MH3080Mfg Feb 2019 · Exp Oct 2020 | Piramal Enterprises LtdMaharashtra | Assay of CyanocobalaminAssay | RDTL ChandigarhCDSCO lab |
| Fexofendine Tablets I.P. 180 mg | Batch JDT-3617Mfg Sep 2018 · Exp Aug 2020 | Jpee DrugsUttarakhand | DissolutionDissolution | CDL KolkataCDSCO lab |
| Ewit-DSR Capsules (Esomeprazole- 40mg (E.C) & Domperidone 30 mg (SR) Capsules) | Batch C-6601Mfg Aug 2018 · Exp Jul 2020 | A.S. LifesciencesHaryana | Dissolution for EsomeprazoleDissolution | CDTL MumbaiCDSCO lab |
| Diclofenac Sodium Tablets I.P. 50 mg | Batch 1511917Mfg Oct 2017 · Exp Sep 2019 | Karnataka Antibiotics & Pharmaceuticals LtdKarnataka | Disintegration & Related SubstancesDisintegration | CDL KolkataCDSCO lab |
| Diclofenac Sodium Tablets I.P. 50 mg | Batch 1508318Mfg May 2018 · Exp Apr 2020 | Karnataka Antibiotics & Pharmaceuticals LtdKarnataka | Related SubstancesRelated substances | CDL KolkataCDSCO lab |
| Diclofenac Sodium Tablets I.P. 50 mg | Batch 1512117Mfg Nov 2017 · Exp Oct 2019 | Karnataka Antibiotics & Pharmaceuticals LtdKarnataka | Disintegration & Related SubstancesDisintegration | CDL KolkataCDSCO lab |
| Diclofenac Sodium Injection I.P. | Batch I-17507Mfg Jul 2018 · Exp Jun 2020 | Jackson Laboratories Pvt. LtdPunjab | Description & Particulate MatterDescription | CDL KolkataCDSCO lab |
| Ciprofloxacin Tablets IP (P-CIP 500 Tabelets) | Batch R-21119Mfg Dec 2018 · Exp Nov 2020 | Pansun PharmaceuticalsUttarakhand | Identification and AssayAssay | RDTL ChandigarhState lab |
| Calcium and Vitamin D3 Tablets IP (500 mg + 250 IU) | Batch CWTV-56Mfg Sep 2018 · Exp Aug 2020 | Nestor Pharmaceuticals LimitedHaryana | Assay of Vitamin D3Assay | CDTL MumbaiCDSCO lab |
| Albendazole Tablets I.P. 400 mg | Batch ABT18032Mfg Aug 2018 · Exp Jul 2020 | Vivek Pharmachem (India) LtdRajasthan | DissolutionDissolution | RDTL GuwahatiState lab |
| (Cefotaxime Injection IP) | Batch B028004AMfg Jul 2018 · Exp Jun 2020 | ANG Lifesciences India LtdHimachal Pradesh | Related SubstancesRelated substances | RDTL ChandigarhCDSCO lab |
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Sources
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Changelog
- 3 Nov 2026: table generated from the CDSCO NSQ portal export (18 rows). Revised CDSCO lists are diffed on each monthly rebuild.