CDSCO monthly lab alert

CDSCO NSQ alert, May 2019: 33 drug batches flagged

By Blacklisted editorial team· Published 20 Jun 2019· Updated 20 Sep 2026· Source: CDSCO NSQ portal

In its May 2019 alert, the Central Drugs Standard Control Organisation listed 33 drug batches that failed quality tests, 23 at central laboratories and 10 at state drug-testing laboratories, from 28 manufacturers across 30 products. The most common failure was dissolution, and the most-represented manufacturing state was Himachal Pradesh. Products flagged include Hyaluronidase Injection IP (Ovine) (HYNIDASE INJECTION), Erythromycin Stearate Tablets I.P. 250mg, Valate 200 (Sodium Valproate Gastro- Resistant Tablets I.P. 200 mg).

33
Batches flagged
23 / 10
Central / state labs
Dissolution
Top reason
28
Manufacturers

Batches per month, last 12 alerts

Jan 2019May 2019 · 33

Full list of NSQ batches, May 2019

Download CSV
Product Batch Manufacturer Reason declared NSQ Tested by
Valate 200 (Sodium Valproate Gastro- Resistant Tablets I.P. 200 mg) ACJ28001Mfg 2018-06 · Exp 2020-05 Psychotropics India LtdUttarakhand Related substancesRelated substances CDL KolkataCDSCO lab
Telmisartan Tablets I.P. 20 mg. (Ezisartan 20) VT17-4089Mfg 2017-11 · Exp 2019-10 Athens Life SciencesHimachal Pradesh DissolutionDissolution RDTL GuwahatiState lab
Serratiopeptidase Tablets I.P. 10 mg EST13Mfg 2017-07 · Exp 2019-06 Elegant Drugs Pvt. LtdKarnataka Assay & DisintegrationAssay CDL KolkataCDSCO lab
Ramipril Tablets IP 2.5 mg (RAMIZIM- 2.5 TABLETS) EH97F801Mfg 2018-06 · Exp 2020-05 Zim Laboratories LimitedMaharashtra AssayAssay RDTL ChandigarhCDSCO lab
Parazim-20 (Omeprazole Gastro-Resistant Capsules IP 20 mg) FZ04B802Mfg 2018-02 · Exp 2021-01 Zim Laboratories LimitedMaharashtra DissolutionDissolution CDTL MumbaiCDSCO lab
Paracetamol Tablets I.P. 500 mg. CT70154Mfg 2017-06 · Exp 2019-05 Omega Biotech LtdUttarakhand DissolutionDissolution RDTL GuwahatiState lab
PRIMAQUINE PHOSPHATE TABLETS IP 2.5 MG) T-17648Mfg 2018-08 · Exp 2020-07 Jackson Laboratories Pvt. LtdPunjab DissolutionDissolution RDTL ChandigarhState lab
Ofloxacin Tablets I.P. (DRFLOX-200) DRB-009Mfg 2017-07 · Exp 2019-06 Park PharmaceuticalsHimachal Pradesh DissolutionDissolution RDTL GuwahatiState lab
Nitrofurantoin Capsules USP 100mg (URIFAST CAPSULES) BA82286Mfg 2018-07 · Exp 2020-06 Cipla LtdHimachal Pradesh DissolutionDissolution RDTL ChandigarhCDSCO lab
NORSHOT (Sterile Noradrenaline Concentrate I.P. 2 mg/ml, 2ml) 17200Mfg 2017-11 · Exp 2019-10 Swiss Parenterals LtdGujarat Description & Particulate MatterDescription CDL KolkataCDSCO lab
Misoprostol Tablets I.P. 200 mcg MST 18SGET035Mfg 2018-05 · Exp 2020-04 Synokem Pharmaceuticals LtdUttarakhand AssayAssay CDL KolkataCDSCO lab
Menadione Sodium Bisulphate Injection IP (1966) 10mg/ml (VITAMIN K3 INJECTION) I-17549Mfg 2018-08 · Exp 2020-07 Jackson Laboratories Pvt. LtdPunjab Particulate matterParticulate matter RDTL ChandigarhCDSCO lab
MARIAGO (Methylergometrine Maleate Injection I.P.) P7274Mfg 2017-06 · Exp 2019-05 Bharat Parenterals LtdGujarat AssayAssay CDL KolkataCDSCO lab
Loperamide Hydrochloride Tablets IP (LOPSOL TABLETS) BT-391Mfg 2018-08 · Exp 2020-07 Boffin Biotech Pvt. LtdHimachal Pradesh DissolutionDissolution RDTL ChandigarhState lab
Hyaluronidase Injection IP (Ovine) (HYNIDASE INJECTION) SA1812060Mfg 2018-06 · Exp 2021-05 Shreya Life Sciences Pvt. Ltd Particulate matterParticulate matter RDTL ChandigarhState lab
Hyaluronidase Injection IP (Ovine) (HYNIDASE INJECTION) SA1812059Mfg 2018-06 · Exp 2021-05 Shreya Life Sciences Pvt. Ltd Particulate matterParticulate matter RDTL ChandigarhState lab
Hyaluronidase Injection IP (Ovine) (HYNIDASE INJECTION) SA1812059Mfg 2018-06 · Exp 2021-05 Shreya Life Sciences Pvt. Ltd Particulate matterParticulate matter RDTL ChandigarhState lab
Herzovir Lyophillized Powder (Aciclovir Intravenous Infusion I.P.) GN1310AMfg 2017-11 · Exp 2019-10 MMG HealthcareHimachal Pradesh Particulate MatterParticulate matter CDL KolkataCDSCO lab
Frusemide Tablets I.P. 40 mg 7127Mfg 2017-06 · Exp 2020-05 Ramson RemediesPunjab DissolutionDissolution RDTL GuwahatiState lab
Fluconazole Tablets IP (FLUTIS-150 TABLETS) SDS874Mfg 2018-05 · Exp 2020-04 Scott-Edil Pharmacia LtdHimachal Pradesh DissolutionDissolution RDTL ChandigarhCDSCO lab
FURAZOLIDONE ORAL SUSPENSION IP 1803Mfg 2018-06 · Exp 2020-05 Deepin Pharmaceuticals Pvt. Ltd AssayAssay CDTL ChennaiCDSCO lab
Erythromycin Stearate Tablets I.P. 250mg GPT005Mfg 2018-10 · Exp 2020-09 Omega PharmaUttarakhand DissolutionDissolution CDL KolkataCDSCO lab
Erythromycin Stearate Tablets I.P. 250mg GPT003Mfg 2018-10 · Exp 2020-09 Omega PharmaUttarakhand DissolutionDissolution CDL KolkataCDSCO lab
Clopican* A (Clopidogrel Bisulphate and Aspirin Tablets) CCAT-018Mfg 2018-10 · Exp 2020-09 IOSIS Remedies Pvt LtdHimachal Pradesh Free Salicylic Acid TestOther CDL KolkataCDSCO lab
Chlorpheniramine Maleate Tablets IP 4 mg (CPM) 12-1904Mfg 2018-11 · Exp 2020-10 Vintochem Pharmaceuticals Related SubstancesRelated substances CDTL MumbaiCDSCO lab
Chloramphenicol and Dexamethasone Sodium Eye Drops (POLYMICIN EYE DROPS) POLY-07Mfg 2018-07 · Exp 2020-06 VADSP PharmaceuticalsHimachal Pradesh Assay of Chloramphenicol, and Dexamethasone Sodium PhosphateAssay RDTL ChandigarhCDSCO lab
Calcium and Vitamin D3 Tablets I.P. KTB8010ALMfg 2018-07 · Exp 2020-06 Karnataka Antibiotics & Pharmaceuticals LtdKarnataka Assay of ?Vitamin D3?Assay CDL KolkataCDSCO lab
COMBit (Tablets of Botin, Iron, Lysine, N-Acetyl Cysteine, Vitamin B12 & Minerals) 1801820Mfg 2018-06 · Exp 2019-11 Phoenix LaboratoriesAssam Assay of ?N- Acetyl Cysteine? and ?Zinc Sulphate Monohydrate?Assay CDL KolkataCDSCO lab
Betahistine Tablets I.P. 16 mg 767-02Mfg 2017-07 · Exp 2019-12 Hab Pharmaceuticals & Research LimitedUttarakhand Assay & Uniformity of ContentAssay CDL KolkataCDSCO lab
Atriflam (Aceclofenac, Paracetamol & Serratiopeptidase Tablets) SAMT1803Mfg 2018-10 · Exp 2020-09 Goodman PharmaceuticalsPuducherry Assay of SerratiopeptidaseAssay CDL KolkataCDSCO lab
Atorvastatin Tablets IP (LIPVEN-20 TABLETS) VT-17230Mfg 2017-12 · Exp 2019-11 Sunlife SciencesUttarakhand Dissolution (Atorvastatin Calcium calculated as Atorvastatin)Dissolution RDTL ChandigarhCDSCO lab
Artesunate Injection (Neosunate) 115825Mfg 2018-06 · Exp 2020-05 Neon Laboratories LtdMaharashtra Particulate ContaminationParticulate matter RDTL GuwahatiState lab
Amlodipine Tablets IP 10 mg (AMLOSAFE 10 TABLETS) M129L018Mfg 2018-11 · Exp 2020-10 Aristo Pharmaceuticals Pvt. Ltd DissolutionDissolution RDTL ChandigarhCDSCO lab

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Changelog

  • 20 Sep 2026: table generated from the CDSCO NSQ portal export (33 rows). Revised CDSCO lists are diffed on each monthly rebuild.