CDSCO monthly lab alert

CDSCO NSQ alert, February 2019: 37 drug batches flagged

By Blacklisted editorial team· Published 20 Mar 2019· Updated 3 Nov 2026· Source: CDSCO NSQ portal

In its February 2019 alert, the Central Drugs Standard Control Organisation listed 37 drug batches that failed quality tests, 24 at central laboratories and 13 at state drug-testing laboratories, from 31 manufacturers across 34 products. The most common failure was assay, and the most-represented manufacturing state was Himachal Pradesh. Products flagged include THIAMIN 2ml (THIAMINE HCl Injection I.P. 100 mg/ml), Sodium Chloride (0.45%) & Dextrose (5.0%) Inj. I.P 5 D � NS), Ranitac 150 (Ranitidine Hydrochloride Tablets I.P. 150mg).

37
Batches flagged
24 / 13
Central / state labs
Assay
Top reason
31
Manufacturers

Batches per month, last 12 alerts

Jan 2019Feb 2019 · 37

Full list of NSQ batches, February 2019

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Product Batch Manufacturer Reason declared NSQ Tested by
THIAMIN 2ml (THIAMINE HCl Injection I.P. 100 mg/ml) Batch 18AA004Mfg Jan 2018 · Exp Jun 2019 Pharmafabrikon pHpH CDSCO, HyderabadState lab
Sodium Chloride (0.45%) & Dextrose (5.0%) Inj. I.P 5 D � NS) Batch P8220003Mfg Feb 2018 · Exp Jan 2021 Albert David LtdUttar Pradesh Assay of DextroseAssay CDSCO, HyderabadState lab
Ranitac 150 (Ranitidine Hydrochloride Tablets I.P. 150mg) Batch M-9805Mfg Jul 2018 · Exp Jun 2020 Herb Edge Healthcare Pvt. Ltd Description & AssayAssay CDSCO, AhmedabadState lab
Ramipril Tablets IP 5 mg (RIMPRIL-5 TABLETS) Batch KT/262Mfg Jan 2018 · Exp Dec 2019 Magbro Healthcare Pvt. LtdHimachal Pradesh Assay of RamiprilAssay RDTL ChandigarhCDSCO lab
Primaquine Tablets IP 7.5 mg (P- QUINE TABLETS) Batch KTQ1342Mfg Dec 2017 · Exp Nov 2019 Pro-pharma Care Pvt. LtdUttarakhand Dissolution (Primaquine Phosphate calculated as Primaquine) and the Assay of Primaquine Phosphate calculated as Primaquine.Assay RDTL ChandigarhCDSCO lab
Paracetamol Tablets I.P. (LARKIN) Batch E-10Mfg Aug 2017 · Exp Jul 2019 Lark Laboratories (India) LtdRajasthan DissolutionDissolution Drugs Control Department, MizoramCDSCO lab
Pantoprazole Injection Batch PZD-046Mfg Jul 2018 · Exp Jun 2020 Daffodills Pharmaceuticals Ltd Particulate ContaminationParticulate matter Drugs Control Department, AssamCDSCO lab
PHENOBARBITAL ORAL SOLUTION USP Batch SY-17200Mfg Jun 2018 · Exp May 2020 Jackson Laboratories Pvt. LtdPunjab Alcohol Determination.Other Drug Control Jammu & KashmirCDSCO lab
Omeprazole Capsules I.P. 20 mg. (OMEP) Batch UOME1801Mfg Feb 2018 · Exp Jan 2020 Bal Pharma LimitedUttarakhand DissolutionDissolution Drugs Control Department, TripuraCDSCO lab
Nitroglycerin Injection USP (GLICIN INJECTION) Batch BIO-17441Mfg May 2017 · Exp Apr 2019 Health Biotech LtdHimachal Pradesh Description, Particulate matter, Alcohol Determination and the Assay of Diluted Nitroglycerin calculated as NitroglycerinAssay RDTL ChandigarhCDSCO lab
Misoprostol Tablets I.P. 200 mcg, Batch 18SGCT012Mfg Mar 2018 · Exp Feb 2020 Synokem Pharmaceuticals LtdUttarakhand AssayAssay CDSCO, East Zone, KolkataState lab
Menadione Sodium Bisulphite Injection 1 ml Batch 51Mfg Feb 2018 · Exp Jan 2020 Hindustan Medicines Pvt. Ltd Description and Particulate MatterDescription CDSCO, South Zone, ChennaiState lab
MAANZEN CR 400 Tablets (Carbamazepine Controlled Release Tablets 400 mg) Batch CCT/6005Mfg Oct 2016 · Exp Sep 2019 Maan Pharmaceuticals LtdGujarat DissolutionDissolution CDSCO, Sub zone, BangaloreState lab
Leucovorin Calcium Injection I.P. Batch 887YY042Mfg Dec 2017 · Exp Nov 2019 Fresenius Kabi Oncology LtdHimachal Pradesh Description and Particulate MatterDescription CDSCO, Sub Zone, BaddiState lab
Letrozole Tablets USP 2.5 mg (BREXOL-2.5 TABLETS) Batch EN1804140TMfg Apr 2018 · Exp Mar 2020 Enrico PharmaceuticalsHimachal Pradesh Dissolution (Letrozole).Dissolution RDTL ChandigarhCDSCO lab
Ketorolac Tromethamine Injection I.P. 1 ml, Batch I-4754Mfg Mar 2017 · Exp Feb 2019 Jackson Laboratories Pvt. Ltd Description and Particulate MatterDescription CDSCO, East Zone, KolkataState lab
Fexofenadine Hydrochloride Tablets IP (FEXOFINE-180 TABLETS) Batch AT/3083Mfg Jul 2018 · Exp Jun 2020 Apple BiotechPunjab Dissolution (After 10 Min), (After 30 min).Dissolution RDTL ChandigarhCDSCO lab
Esopen ? 20 (Esomeprazole Tablets I.P.) Batch NT-171147Mfg Nov 2017 · Exp Oct 2019 Gracure Pharmaceuticals LtdHimachal Pradesh DissolutionDissolution CDSCO, South Zone, ChennaiState lab
Doxycycline and Lactic Acid Bacillus Capsules (DOXYGUARD CAPSULES) Batch SOC-615FMfg Jan 2018 · Exp Dec 2019 Symbiosis Pharmaceuticals Pvt. LtdHimachal Pradesh Assay of Lactic Acid BacillusAssay RDTL ChandigarhCDSCO lab
Dobutamine Injection USP (CARDIOTONIC INJECTION) Batch N-10085Mfg Sep 2017 · Exp Aug 2019 Kwality Pharmaceuticals LtdPunjab Particulate matterParticulate matter RDTL ChandigarhCDSCO lab
Dexamethasone Tablets I.P. 0.5 mg Batch GSM-17332Mfg May 2017 · Exp Apr 2019 Max Chem Pharmaceuticals Pvt. LtdUttarakhand Related SubstancesRelated substances CDSCO, South Zone, ChennaiState lab
Clopidogrel and Aspirin Tablets (CLOPIJACK-A TABLETS) Batch T-16413Mfg Mar 2018 · Exp Feb 2020 Jackson Laboratories Pvt. LtdPunjab Salicylic acid and Assay of Clopidogrel Bisulphate calculated as Clopidogrel, AspirinAssay RDTL ChandigarhCDSCO lab
Chloroquine Phosphate Tablets IP 250 mg Batch 170819Mfg Aug 2017 · Exp Jul 2020 Modi AntibioticsGujarat Dissolution (Chloroquine Phosphate).Dissolution CDSCO, North Zone, GZBCDSCO lab
Ceftriaxone & Tazobactam For Injection (VEGACEF-TZ) Batch CFTN17008FMfg Apr 2017 · Exp Mar 2019 Theon Pharmaceuticals LtdHimachal Pradesh Particulate ContaminationParticulate matter Drugs Control Department, MizoramCDSCO lab
Ceftazidime & Tazobactam For Injection (Cefazid-T) Batch CT-1801Mfg Apr 2018 · Exp Mar 2020 Systochem Laboratories Ltd Particulate ContaminationParticulate matter Drugs Control Department, Arunachal PradeshCDSCO lab
Cefpodoxime Proxetil Tablets IP (EUROPOD-200 TABLETS) Batch FCFT-206Mfg Jan 2018 · Exp Jun 2019 Crystal PharmaceuticalsHaryana Dissolution (Cefpodoxime Proxetil calculated as Cefpodoxime) and the Assay of Cefpodoxime Proxetil calculated as Cefpodoxime.Assay CDSCO, North Zone, GZBCDSCO lab
Cefpodoxime Oral Suspension I.P. (MONOPOD) Batch 17J-BD502Mfg Jan 2018 · Exp Jun 2019 Orison Pharma International AssayAssay Drugs Control Department, Arunachal PradeshCDSCO lab
Cefixime And Lactic Acid Bacillus Dispersible Tablets (EUROX-200 LB TABLETS) Batch T180064FMfg Apr 2018 · Exp Mar 2020 Polestar Power Industries (Pharma Division)Himachal Pradesh Assay of Lactic Acid BacillusAssay RDTL ChandigarhCDSCO lab
Cefixime & Lactic Acid Bacillus Tablets (Tixi-200 LB) Batch FSP17159AMfg Oct 2017 · Exp Sep 2019 Salus PharmaceuticalsHimachal Pradesh Uniformity of WeightUniformity of weight/content Drugs Control Department, MizoramCDSCO lab
Azithromycin Oral Suspension IP (AZM-200 SUSPENSION) Batch 17SGDL002Mfg Apr 2017 · Exp Mar 2019 Synokem Pharmaceuticals LtdUttarakhand Related substances and the Assay of Azithromycin calculated as Anhydrous AzithromycinAssay RDTL ChandigarhState lab
Amoxycillin Capsules IP (Amoxytor-250) Batch HCB709LMfg Nov 2017 · Exp Oct 2020 Himalaya Meditek Pvt. LtdUttarakhand AssayAssay Drugs Control Department, Arunachal PradeshCDSCO lab
Aceclofenac, Paracetamol and Serratiopeptidase Tablets (HIFEIN-SP TABLETS) Batch AHT-6615Mfg Mar 2018 · Exp Feb 2020 Algen Healthcare LimitedHimachal Pradesh Disintegration Test and Assay of AceclofenacAssay RDTL ChandigarhState lab
Absorbent Gauze Sch. F(II) Batch 83Mfg Jul 2017 · Exp Jun 2019 K. Ramakrishnan & SonsTamil Nadu Weight in g/m2Weight CDSCO, SubZone GoaCDSCO lab
AZTEC (Ranitidine Injection I.P. 2 ml) Batch BATC-245Mfg Jan 2018 · Exp Dec 2019 Ind-Swift LtdHimachal Pradesh pHpH CDSCO, SubZone GoaState lab
(DOBUTAMINE INJECTION USP) Batch N-10123Mfg Oct 2017 · Exp Sep 2019 Kwality Pharmaceuticals LtdPunjab Particulate matterParticulate matter RDTL ChandigarhCDSCO lab
(CALCIUM GLUCONATE INJECTION IP 10% W/V)?, Batch I-17041Mfg May 2018 · Exp Apr 2020 Jackson Laboratories Pvt. LtdPunjab Particulate matterParticulate matter RDTL ChandigarhCDSCO lab
(CALCIUM GLUCONATE INJECTION IP 10% W/V) Batch I-17933Mfg Oct 2018 · Exp Sep 2020 Jackson Laboratories Pvt. LtdPunjab Bacterial endotoxinsBacterial endotoxins RDTL ChandigarhCDSCO lab

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Changelog

  • 3 Nov 2026: table generated from the CDSCO NSQ portal export (37 rows). Revised CDSCO lists are diffed on each monthly rebuild.