CDSCO monthly lab alert

CDSCO NSQ alert, July 2019: 18 drug batches flagged

By Blacklisted editorial team· Published 20 Aug 2019· Updated 20 Sep 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 CHT019001Mfg 2019-02 · Exp 2022-01 Sai Tech Pharmaceuticals Pvt. LtdMaharashtra Test for Piperidine HydrochlorideOther CDTL MumbaiCDSCO lab
Regunac� - 50 (Diclofenac Gastro- Resistant Tablets I.P. 50 mg) FZ57F801Mfg 2018-06 · Exp 2021-05 Zim Laboratories LimitedMaharashtra DescriptionDescription CDL KolkataCDSCO lab
Prednisolone Acetate and Moxifloxacin Ophthalmic Suspension(M- Floxin-P Eye Drops) O-066Mfg 2018-04 · Exp 2020-03 Oscar Remedies Pvt. LtdHaryana Particle size and Assay of Predisolone AcetateAssay RDTL ChandigarhState lab
Phenytoin Oral Suspension I.P. 8L03129Mfg 2018-04 · Exp 2020-03 Ciron Drugs & Pharmaceuticals Pvt. LtdMaharashtra AssayAssay CDL KolkataCDSCO lab
Parazim 650 (Paracetamol Tablets I.P. 650 mg) FAX8A801Mfg 2018-01 · Exp 2020-12 Zim Laboratories LimitedMaharashtra DissolutionDissolution CDL KolkataCDSCO lab
Paracetamol Tablets I.P. 500 mg PR1902Mfg 2019-01 · Exp 2020-12 Danish Health Care (P) Ltd DissolutionDissolution RDTL GuwahatiState lab
Pantoprazole Gastro Resistant Tablets I.P. 40 mg T-7164Mfg 2018-10 · Exp 2020-09 Kwality Pharmaceuticals LtdPunjab Dissolution (Both Acid Stage & Buffer Stage)Dissolution RDTL GuwahatiState lab
Multivitamin Tablets with minerals and Trace Elements (Supradyn Tablets) MH3080Mfg 2019-02 · Exp 2020-10 Piramal Enterprises LtdMaharashtra Assay of CyanocobalaminAssay RDTL ChandigarhCDSCO lab
Fexofendine Tablets I.P. 180 mg JDT-3617Mfg 2018-09 · Exp 2020-08 Jpee DrugsUttarakhand DissolutionDissolution CDL KolkataCDSCO lab
Ewit-DSR Capsules (Esomeprazole- 40mg (E.C) & Domperidone 30 mg (SR) Capsules) C-6601Mfg 2018-08 · Exp 2020-07 A.S. LifesciencesHaryana Dissolution for EsomeprazoleDissolution CDTL MumbaiCDSCO lab
Diclofenac Sodium Tablets I.P. 50 mg 1511917Mfg 2017-10 · Exp 2019-09 Karnataka Antibiotics & Pharmaceuticals LtdKarnataka Disintegration & Related SubstancesDisintegration CDL KolkataCDSCO lab
Diclofenac Sodium Tablets I.P. 50 mg 1508318Mfg 2018-05 · Exp 2020-04 Karnataka Antibiotics & Pharmaceuticals LtdKarnataka Related SubstancesRelated substances CDL KolkataCDSCO lab
Diclofenac Sodium Tablets I.P. 50 mg 1512117Mfg 2017-11 · Exp 2019-10 Karnataka Antibiotics & Pharmaceuticals LtdKarnataka Disintegration & Related SubstancesDisintegration CDL KolkataCDSCO lab
Diclofenac Sodium Injection I.P. I-17507Mfg 2018-07 · Exp 2020-06 Jackson Laboratories Pvt. LtdPunjab Description & Particulate MatterDescription CDL KolkataCDSCO lab
Ciprofloxacin Tablets IP (P-CIP 500 Tabelets) R-21119Mfg 2018-12 · Exp 2020-11 Pansun PharmaceuticalsUttarakhand Identification and AssayAssay RDTL ChandigarhState lab
Calcium and Vitamin D3 Tablets IP (500 mg + 250 IU) CWTV-56Mfg 2018-09 · Exp 2020-08 Nestor Pharmaceuticals LimitedHaryana Assay of Vitamin D3Assay CDTL MumbaiCDSCO lab
Albendazole Tablets I.P. 400 mg ABT18032Mfg 2018-08 · Exp 2020-07 Vivek Pharmachem (India) LtdRajasthan DissolutionDissolution RDTL GuwahatiState lab
(Cefotaxime Injection IP) B028004AMfg 2018-07 · Exp 2020-06 ANG Lifesciences India LtdHimachal Pradesh Related SubstancesRelated substances RDTL ChandigarhCDSCO lab

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Changelog

  • 20 Sep 2026: table generated from the CDSCO NSQ portal export (18 rows). Revised CDSCO lists are diffed on each monthly rebuild.