CDSCO monthly lab alert

CDSCO NSQ alert, February 2019: 37 drug batches flagged

By Blacklisted editorial team· Published 20 Mar 2019· Updated 20 Sep 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) 18AA004Mfg 2018-01 · Exp 2019-06 Pharmafabrikon pHpH CDSCO, HyderabadState lab
Sodium Chloride (0.45%) & Dextrose (5.0%) Inj. I.P 5 D � NS) P8220003Mfg 2018-02 · Exp 2021-01 Albert David LtdUttar Pradesh Assay of DextroseAssay CDSCO, HyderabadState lab
Ranitac 150 (Ranitidine Hydrochloride Tablets I.P. 150mg) M-9805Mfg 2018-07 · Exp 2020-06 Herb Edge Healthcare Pvt. Ltd Description & AssayAssay CDSCO, AhmedabadState lab
Ramipril Tablets IP 5 mg (RIMPRIL-5 TABLETS) KT/262Mfg 2018-01 · Exp 2019-12 Magbro Healthcare Pvt. LtdHimachal Pradesh Assay of RamiprilAssay RDTL ChandigarhCDSCO lab
Primaquine Tablets IP 7.5 mg ( P- QUINE TABLETS ) KTQ1342Mfg 2017-12 · Exp 2019-11 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) E-10Mfg 2017-08 · Exp 2019-07 Lark Laboratories (India) LtdRajasthan DissolutionDissolution Drugs Control Department, MizoramCDSCO lab
Pantoprazole Injection PZD-046Mfg 2018-07 · Exp 2020-06 Daffodills Pharmaceuticals Ltd Particulate ContaminationParticulate matter Drugs Control Department, AssamCDSCO lab
PHENOBARBITAL ORAL SOLUTION USP SY-17200Mfg 2018-06 · Exp 2020-05 Jackson Laboratories Pvt. LtdPunjab Alcohol Determination.Other Drug Control Jammu & KashmirCDSCO lab
Omeprazole Capsules I.P. 20 mg. (OMEP) UOME1801Mfg 2018-02 · Exp 2020-01 Bal Pharma LimitedUttarakhand DissolutionDissolution Drugs Control Department, TripuraCDSCO lab
Nitroglycerin Injection USP (GLICIN INJECTION) BIO-17441Mfg 2017-05 · Exp 2019-04 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, 18SGCT012Mfg 2018-03 · Exp 2020-02 Synokem Pharmaceuticals LtdUttarakhand AssayAssay CDSCO, East Zone, KolkataState lab
Menadione Sodium Bisulphite Injection 1 ml 51Mfg 2018-02 · Exp 2020-01 Hindustan Medicines Pvt. Ltd Description and Particulate MatterDescription CDSCO, South Zone, ChennaiState lab
MAANZEN CR 400 Tablets (Carbamazepine Controlled Release Tablets 400 mg) CCT/6005Mfg 2016-10 · Exp 2019-09 Maan Pharmaceuticals LtdGujarat DissolutionDissolution CDSCO, Sub zone, BangaloreState lab
Leucovorin Calcium Injection I.P. 887YY042Mfg 2017-12 · Exp 2019-11 Fresenius Kabi Oncology LtdHimachal Pradesh Description and Particulate MatterDescription CDSCO, Sub Zone, BaddiState lab
Letrozole Tablets USP 2.5 mg (BREXOL-2.5 TABLETS) EN1804140TMfg 2018-04 · Exp 2020-03 Enrico PharmaceuticalsHimachal Pradesh Dissolution (Letrozole).Dissolution RDTL ChandigarhCDSCO lab
Ketorolac Tromethamine Injection I.P. 1 ml, I-4754Mfg 2017-03 · Exp 2019-02 Jackson Laboratories Pvt. Ltd Description and Particulate MatterDescription CDSCO, East Zone, KolkataState lab
Fexofenadine Hydrochloride Tablets IP (FEXOFINE-180 TABLETS) AT/3083Mfg 2018-07 · Exp 2020-06 Apple BiotechPunjab Dissolution (After 10 Min), (After 30 min).Dissolution RDTL ChandigarhCDSCO lab
Esopen ? 20 (Esomeprazole Tablets I.P.) NT-171147Mfg 2017-11 · Exp 2019-10 Gracure Pharmaceuticals LtdHimachal Pradesh DissolutionDissolution CDSCO, South Zone, ChennaiState lab
Doxycycline and Lactic Acid Bacillus Capsules (DOXYGUARD CAPSULES ) SOC-615FMfg 2018-01 · Exp 2019-12 Symbiosis Pharmaceuticals Pvt. LtdHimachal Pradesh Assay of Lactic Acid BacillusAssay RDTL ChandigarhCDSCO lab
Dobutamine Injection USP (CARDIOTONIC INJECTION) N-10085Mfg 2017-09 · Exp 2019-08 Kwality Pharmaceuticals LtdPunjab Particulate matterParticulate matter RDTL ChandigarhCDSCO lab
Dexamethasone Tablets I.P. 0.5 mg GSM-17332Mfg 2017-05 · Exp 2019-04 Max Chem Pharmaceuticals Pvt. LtdUttarakhand Related SubstancesRelated substances CDSCO, South Zone, ChennaiState lab
Clopidogrel and Aspirin Tablets (CLOPIJACK-A TABLETS) T-16413Mfg 2018-03 · Exp 2020-02 Jackson Laboratories Pvt. LtdPunjab Salicylic acid and Assay of Clopidogrel Bisulphate calculated as Clopidogrel, AspirinAssay RDTL ChandigarhCDSCO lab
Chloroquine Phosphate Tablets IP 250 mg 170819Mfg 2017-08 · Exp 2020-07 Modi AntibioticsGujarat Dissolution (Chloroquine Phosphate).Dissolution CDSCO, North Zone, GZBCDSCO lab
Ceftriaxone & Tazobactam For Injection (VEGACEF-TZ) CFTN17008FMfg 2017-04 · Exp 2019-03 Theon Pharmaceuticals LtdHimachal Pradesh Particulate ContaminationParticulate matter Drugs Control Department, MizoramCDSCO lab
Ceftazidime & Tazobactam For Injection (Cefazid-T) CT-1801Mfg 2018-04 · Exp 2020-03 Systochem Laboratories Ltd Particulate ContaminationParticulate matter Drugs Control Department, Arunachal PradeshCDSCO lab
Cefpodoxime Proxetil Tablets IP (EUROPOD-200 TABLETS) FCFT-206Mfg 2018-01 · Exp 2019-06 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) 17J-BD502Mfg 2018-01 · Exp 2019-06 Orison Pharma International AssayAssay Drugs Control Department, Arunachal PradeshCDSCO lab
Cefixime And Lactic Acid Bacillus Dispersible Tablets ( EUROX-200 LB TABLETS ) T180064FMfg 2018-04 · Exp 2020-03 Polestar Power Industries (Pharma Division)Himachal Pradesh Assay of Lactic Acid BacillusAssay RDTL ChandigarhCDSCO lab
Cefixime & Lactic Acid Bacillus Tablets (Tixi-200 LB) FSP17159AMfg 2017-10 · Exp 2019-09 Salus PharmaceuticalsHimachal Pradesh Uniformity of WeightUniformity of weight/content Drugs Control Department, MizoramCDSCO lab
Azithromycin Oral Suspension IP (AZM-200 SUSPENSION) 17SGDL002Mfg 2017-04 · Exp 2019-03 Synokem Pharmaceuticals LtdUttarakhand Related substances and the Assay of Azithromycin calculated as Anhydrous AzithromycinAssay RDTL ChandigarhState lab
Amoxycillin Capsules IP (Amoxytor-250) HCB709LMfg 2017-11 · Exp 2020-10 Himalaya Meditek Pvt. LtdUttarakhand AssayAssay Drugs Control Department, Arunachal PradeshCDSCO lab
Aceclofenac, Paracetamol and Serratiopeptidase Tablets (HIFEIN-SP TABLETS) AHT-6615Mfg 2018-03 · Exp 2020-02 Algen Healthcare LimitedHimachal Pradesh Disintegration Test and Assay of AceclofenacAssay RDTL ChandigarhState lab
Absorbent Gauze Sch. F(II) 83Mfg 2017-07 · Exp 2019-06 K. Ramakrishnan & SonsTamil Nadu Weight in g/m2Weight CDSCO, SubZone GoaCDSCO lab
AZTEC (Ranitidine Injection I.P. 2 ml) BATC-245Mfg 2018-01 · Exp 2019-12 Ind-Swift LtdHimachal Pradesh pHpH CDSCO, SubZone GoaState lab
(DOBUTAMINE INJECTION USP) N-10123Mfg 2017-10 · Exp 2019-09 Kwality Pharmaceuticals LtdPunjab Particulate matterParticulate matter RDTL ChandigarhCDSCO lab
(CALCIUM GLUCONATE INJECTION IP 10% W/V)?, I-17041Mfg 2018-05 · Exp 2020-04 Jackson Laboratories Pvt. LtdPunjab Particulate matterParticulate matter RDTL ChandigarhCDSCO lab
(CALCIUM GLUCONATE INJECTION IP 10% W/V) I-17933Mfg 2018-10 · Exp 2020-09 Jackson Laboratories Pvt. LtdPunjab Bacterial endotoxinsBacterial endotoxins RDTL ChandigarhCDSCO lab

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Changelog

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