CDSCO monthly lab alert

CDSCO NSQ alert, May 2019: 33 drug batches flagged

By Blacklisted editorial team· Published 20 Jun 2019· Updated 3 Nov 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

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

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Sources

Changelog

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