CDSCO monthly lab alert
CDSCO NSQ alert, October 2021: 36 drug batches flagged
By Blacklisted editorial team· Published 20 Nov 2021· Updated 3 Nov 2026· Source: CDSCO NSQ portal
In its October 2021 alert, the Central Drugs Standard Control Organisation listed 36 drug batches that failed quality tests, 22 at central laboratories and 14 at state drug-testing laboratories, from 26 manufacturers across 29 products. The most common failure was sterility, and the most-represented manufacturing state was Himachal Pradesh. Products flagged include Sterile Hypodermic Syringe (2ml), Infusion Set, Ambrolite D+ (Chlorpheniramine, Phenylephrine and Dextromethorphan Syrup).
36
Batches flagged
22 / 14
Central / state labs
Sterility
Top reason
26
Manufacturers
Batches per month, last 12 alerts
Nov 2020Oct 2021 · 36
Full list of NSQ batches, October 2021
Download CSV| Product | Batch | Manufacturer | Reason declared NSQ | Tested by |
|---|---|---|---|---|
| Tramadol Hydrochloride and Acetaminophen Tablets USP (DOLOSAFE D TABLETS) | Batch NDSD-02102Mfg Apr 2021 · Exp Mar 2024 | Tidal Laboratories Pvt. LtdHimachal Pradesh | DissolutionDissolution | RDTL ChandigarhState lab |
| Sterile Hypodermic Syringe 5 ml | Batch 19719Mfg Dec 2019 · Exp Nov 2021 | Gurumangalam InternationalGujarat | SterilitySterility | RDTL GuwahatiState lab |
| Sterile Hypodermic Syringe 05 ML/CC | Batch 19718Mfg Dec 2019 · Exp Nov 2021 | Gurumangalam InternationalGujarat | Sterility & Bacterial EndotoxinSterility | RDTL GuwahatiState lab |
| Sterile Hypodermic Syringe (2ml) | Batch 19502Mfg Dec 2019 · Exp Nov 2021 | Gurumangalam InternationalGujarat | SterilitySterility | RDTL GuwahatiState lab |
| Sterile Hypodermic Syringe (2ml) | Batch 19507Mfg Dec 2019 · Exp Nov 2021 | Gurumangalam InternationalGujarat | SterilitySterility | RDTL GuwahatiState lab |
| Sterile Hypodermic Syringe (2ml) | Batch 19532Mfg Mar 2020 · Exp Feb 2022 | Gurumangalam InternationalGujarat | SterilitySterility | RDTL GuwahatiState lab |
| Ranitidine Tablets IP 150 mg | Batch NSTY-05Mfg Jun 2021 · Exp May 2023 | Hindustan Antibiotics LtdHaryana | Uniformity of weightUniformity of weight/content | CDTL MumbaiCDSCO lab |
| Ranitidine HCl Injection IP 50 mg/2 ml-2ml | Batch SI-727Mfg Mar 2020 · Exp Feb 2022 | Shivam Enterprises (Pharma Division)Himachal Pradesh | Related SubstancesRelated substances | CDL KolkataCDSCO lab |
| Rabeprazole Sodium & Itopride (Sustained Release) Capsules | Batch I4200001Mfg Feb 2020 · Exp Jan 2022 | Innova Captab LtdHimachal Pradesh | AssayAssay | RDTL GuwahatiCDSCO lab |
| Rabeprazole Injection IP 20 mg | Batch PE3AA11Mfg Oct 2019 · Exp Sep 2021 | Pure & Cure Healthcare Pvt. LtdUttarakhand | Clarity of Solution & Particulate MatterParticulate matter | CDL KolkataCDSCO lab |
| RL (Compound Sodium Lactate Injection I.P. 500 ml) (Ringer Lactate Solution for Injection I.P.) | Batch 9068Mfg Sep 2020 · Exp Aug 2022 | Ives Drugs (India) Pvt. LtdMadhya Pradesh | Bacterial Endotoxins Test & SterilitySterility | CDL KolkataCDSCO lab |
| Pregabalin Capsules IP 75 mg | Batch T21003Mfg Jan 2021 · Exp Dec 2022 | Trugen Pharmaceuticals Pvt. LtdUttarakhand | DissolutionDissolution | RDTL GuwahatiState lab |
| Pregabalin Capsules IP | Batch GC210322Mfg May 2021 · Exp Apr 2023 | Theon Pharmaceuticals LtdHimachal Pradesh | Related SubstancesRelated substances | CDTL MumbaiCDSCO lab |
| Pantoprazole Gastro Resistant Tablets I.P. (P-40) | Batch PFT21002MBMfg Feb 2021 · Exp Jan 2023 | Sri Ram Healthcare Pvt. LtdHimachal Pradesh | DissolutionDissolution | RDTL GuwahatiState lab |
| Pancreatin, Bile Constituents and Activated Dimethicone Tablets (ENZOX PLUS TABLETS) | Batch ENZP-02105-02Mfg May 2021 · Exp Apr 2024 | Tidal Laboratories Pvt. LtdHimachal Pradesh | Assay of Activated DimethiconeAssay | RDTL ChandigarhState lab |
| PARACETAMOL TABLETS IP 500 MG | Batch 2518021Mfg Aug 2021 · Exp Jul 2024 | Karnataka Antibiotics & Pharmaceuticals LtdKarnataka | DissolutionDissolution | RDTL ChandigarhCDSCO lab |
| Ofloxacin and Ornidazole Tablets I.P. | Batch TI0005AMfg Sep 2020 · Exp Aug 2022 | Navkar LifesciencesHimachal Pradesh | DissolutionDissolution | RDTL GuwahatiState lab |
| NORFLOXACIN TABLETS IP 400 MG | Batch NT802Mfg Oct 2020 · Exp Sep 2022 | Unicure India LtdUttar Pradesh | DissolutionDissolution | RDTL ChandigarhCDSCO lab |
| Multivitamins, Minerals and L-Lysine Hydrochloride Syrup (BETHADOXIN- 12M SYRUP) | Batch D1105520Mfg Oct 2020 · Exp Mar 2022 | Biological E. LimitedUttarakhand | Identification of Selenium and Assay of Pyridoxine HydrochlorideAssay | RDTL ChandigarhCDSCO lab |
| Methylcobalamin, Vitamin C, Vitamin E, Beta Carotene, Zinc Sulphate, Sodium Selenite, Chromium Picolinate, Lutein and Lycopene Capsules (OCTOXID CAPSULES) | Batch OTXC-02102Mfg Jun 2021 · Exp Nov 2022 | Tidal Laboratories Pvt. LtdHimachal Pradesh | Identification of Methylcobalamin, Vitamin EIdentification | RDTL ChandigarhState lab |
| Meropenem Injection IP 500 mg (MEROMAX 500 MG INJECTION) | Batch DP1013Mfg May 2021 · Exp Apr 2023 | Scott-Edil Pharmacia LtdHimachal Pradesh | Particulate matterParticulate matter | RDTL ChandigarhCDSCO lab |
| Levetiracetam IP | Batch LEV/10/21Mfg Apr 2021 · Exp Mar 2024 | Pranshav Health CareGujarat | Related SubstancesRelated substances | RDTL ChandigarhCDSCO lab |
| KYCOLD-PLUS Suspension- 60 ml (Paracetamol, Phenylephrine HCl, Chlorpheniramine Maleate, Sodium Citrate & Menthol Suspension) | Batch DL5184Mfg Sep 2019 · Exp Aug 2021 | Digital VisionHimachal Pradesh | Assay of Phenylephrine Hydrochloride Negative for Diethylene Glycol (DEG)Assay | CDL KolkataCDSCO lab |
| Infusion Set | Batch 060220Mfg Feb 2020 · Exp Jan 2025 | R. R. Medicare ProductsJammu & Kashmir | SterilitySterility | RDTL GuwahatiState lab |
| Infusion Set | Batch 50220Mfg Feb 2020 · Exp Jan 2025 | R. R. Medicare ProductsJammu & Kashmir | Sterility & Bacterial EndotoxinSterility | RDTL GuwahatiState lab |
| Diclofenac Sodium Tablets IP (DECIFEN-50 TABLETS | Batch CLT-14750Mfg Mar 2020 · Exp Feb 2023 | Caremax FormulationsHimachal Pradesh | Disintegration TestDisintegration | RDTL ChandigarhCDSCO lab |
| DICLOFENAC, VIRGIN LINSEED OIL, METHYL SALICYLATE AND MENTHOL GEL | Batch JZAA02Mfg Jan 2021 · Exp Dec 2022 | Akums Drugs & Pharmaceuticals LtdUttarakhand | Assay of MentholAssay | RDTL ChandigarhCDSCO lab |
| COMPOUND SODIUM LACTATE INJECTION IP | Batch FFS2005B0114Mfg Jun 2020 · Exp May 2023 | Pharma Impex Laboratories Pvt. LtdWest Bengal | Description, pH, Particulate Contamination, Bacterial Endotoxins and SterilityDescription | RDTL ChandigarhCDSCO lab |
| CEFUROXIME AXETIL TABLETS IP 500 MG | Batch XATX-01Mfg Jul 2020 · Exp Jun 2022 | Hindustan Antibiotics LtdHaryana | DissolutionDissolution | RDTL ChandigarhCDSCO lab |
| BUPIVACAINE HYDROCHLORIDE IN DEXTROSE INJECTION USP | Batch HIBU2003GMfg Sep 2020 · Exp Aug 2022 | Health Biotech LtdHimachal Pradesh | Bacterial EndotoxinsBacterial endotoxins | RDTL ChandigarhState lab |
| Amikacin Injection I.P. 2ml | Batch GV1A001Mfg Jan 2021 · Exp Dec 2022 | Scott-Edil Pharmacia LtdHimachal Pradesh | Description & Particulate MatterDescription | CDL KolkataCDSCO lab |
| Ambrolite D+ (Chlorpheniramine, Phenylephrine and Dextromethorphan Syrup) | Batch DJ0I1Mfg May 2020 · Exp Oct 2021 | Healkraft Pharma (India) Pvt. LtdHimachal Pradesh | Assay of Phenylephrine HydrochlorideAssay | CDL KolkataCDSCO lab |
| Ambrolite D+ (Chlorpheniramine, Phenylephrine and Dextromethorphan Syrup) | Batch DJ0I2Mfg May 2020 · Exp Oct 2021 | Healkraft Pharma (India) Pvt. LtdHimachal Pradesh | Assay of Phenylephrine HydrochlorideAssay | CDL KolkataCDSCO lab |
| Acivir - 800 DT (Aciclovir Dispersible Tablets IP 800 mg) | Batch SN01674Mfg Oct 2020 · Exp Sep 2023 | Cipla LtdSikkim | Uniformity of DispersionUniformity of weight/content | CDL KolkataCDSCO lab |
| Absorbent Cotton Wool I.P. (ALTUS) | Batch A/2105Mfg May 2021 · Exp May 2026 | Altus Surgical Pvt. LtdGujarat | Surface Active Substances, Sulphated Ash, Water Soluble substances and NepsWater content | CDL KolkataCDSCO lab |
| Absorbent Cotton Wool I.P. | Batch 172Mfg Jan 2021 · Exp Jan 2024 | Doctor Surgical WorksHaryana | Surface Active Substances, Fluorescence, Sulphated Ash, Water Soluble substances and NepsWater content | CDL KolkataCDSCO lab |
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Sources
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Changelog
- 3 Nov 2026: table generated from the CDSCO NSQ portal export (36 rows). Revised CDSCO lists are diffed on each monthly rebuild.