CDSCO monthly lab alert
CDSCO NSQ alert, August 2023: 48 drug batches flagged
By Blacklisted editorial team· Published 20 Sep 2023· Updated 3 Nov 2026· Source: CDSCO NSQ portal
In its August 2023 alert, the Central Drugs Standard Control Organisation listed 48 drug batches that failed quality tests, 41 at central laboratories and 7 at state drug-testing laboratories, from 41 manufacturers across 45 products. The most common failure was assay, and the most-represented manufacturing state was Himachal Pradesh. Products flagged include Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5 ml syrup (COLD OUT), Trimax Expectorant (Terbutaline Sulphate with BromhexineHCl& Guaiphenesin),, The auto disable syringe (KOJAK SELINGE).
48
Batches flagged
41 / 7
Central / state labs
Assay
Top reason
41
Manufacturers
Batches per month, last 12 alerts
Sep 2022Aug 2023 · 48
Full list of NSQ batches, August 2023
Download CSV| Product | Batch | Manufacturer | Reason declared NSQ | Tested by |
|---|---|---|---|---|
| Trimax Expectorant (Terbutaline Sulphate with BromhexineHCl& Guaiphenesin), | Batch 23009Mfg Jan 2023 · Exp Oct 2024 | Norris Medicines LimitedGujarat | Assay of Bromhexine Hydrochloride &Menthol.This sample is found to contain 0.118% w/v of Ethylene Glycol and this sample does not give positive test for Diethylene GlycolAssay | CDL KolkataCDSCO lab |
| The auto disable syringe (KOJAK SELINGE) | Batch 312053KJ M1Mfg Mar 2023 · Exp Feb 2028 | Hindustan Syringes & Medical Devices LtdHaryana | Design (Piston/Plunger Assembly) Fit of piston in barrelOther | RDTL ChandigarhCDSCO lab |
| Telmisartan and Chlorthalidone Tablets | Batch PF8C006Mfg Sep 2022 · Exp Aug 2024 | Pure & Cure Healthcare Pvt. LtdUttarakhand | Dissolution of ChlorthalidoneDissolution | CDL KolkataCDSCO lab |
| Sterile Noradrenaline Concentrate IP (2mg /1ml) | Batch INABB23 01Mfg Apr 2023 · Exp Mar 2025 | Samarth Life Sciences Pvt. LtdHimachal Pradesh | Description & Particulate MatterDescription | CDL KolkataCDSCO lab |
| Sibolone (Tibolone Tablets IP) | Batch PLSB230 1Mfg Feb 2023 · Exp Sep 2025 | Phaarmasia Ltd | DissolutionDissolution | CDL KolkataCDSCO lab |
| Selamer-400 Tablets (Sevelamer Carbonate Tablets 400 mg) | Batch MT22612 4BMfg Dec 2022 · Exp Nov 2024 | Mascot Health Series Pvt. LtdUttarakhand | DescriptionDescription | CDL KolkataCDSCO lab |
| Refined Glycerin CP Grade | Batch 21100637Mfg Oct 2022 · Exp Sep 2025 | Adani WilmarDelhi | Assay of Glycerin.Thi sample is found to contain 0.025% w/w of Ethylene Glycol and does not give positive result for Diethylene GlycolAssay | CDL KolkataCDSCO lab |
| Rabeprazole Gastro- resistant Tablets IP (RABALKEM-20) | Batch RBL2202 0RHMfg Oct 2022 · Exp Sep 2024 | Ravian Life Science Pvt. LtdUttarakhand | DissolutionDissolution | RDTL GuwahatiState lab |
| Povidone-Iodine Ointment USP 5% w/w | Batch P1040Mfg Aug 2022 · Exp Jul 2025 | Babu Ram Om Prakash (BROP)Himachal Pradesh | Assay of Povidon Iodine calculated asAvailable IodineAssay | RDTL ChandigarhCDSCO lab |
| Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5ml syrup (COLD OUT) | Batch SF001A0 1Mfg Jan 2022 · Exp Dec 2024 | Fourrts (India) Laboratories Pvt. LtdTamil Nadu | Content of Ethylene Glycol 1.9%w/v & Diethylene Glycol 0.14%w/vOther | RDTL GuwahatiCDSCO lab |
| Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5 ml syrup (COLD OUT) | Batch SF001B0 1Mfg Feb 2022 · Exp Jan 2025 | Fourrts (India) Laboratories Pvt. LtdTamil Nadu | Content of Ethylene Glycol 1.22%w/vOther | RDTL GuwahatiCDSCO lab |
| Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5 ml syrup (COLD OUT) | Batch SF001A0 2Mfg Jan 2022 · Exp Dec 2024 | Fourrts (India) Laboratories Pvt. LtdTamil Nadu | Content of Ethylene Glycol 2.23%w/v& Diethylene Glycol 0.17%w/vOther | RDTL GuwahatiCDSCO lab |
| Pantoprazole Gastro Resistant Tablets I.P. (PAVE -40) | Batch BBT2217 94Mfg May 2022 · Exp Apr 2024 | Biomax Biotechnics (P) LtdHaryana | DissolutionDissolution | RDTL GuwahatiState lab |
| Ofloxacin & Metronidazole Benzoate Suspension (VIVFLOX-MZ Suspension) (For Paediatric USE ONLY) | Batch PFS-1204Mfg Nov 2022 · Exp Oct 2024 | Proceed FormulationsPunjab | ASSAY OF METRONIDAZOLE BENZOATE AND OFLOXACINAssay | CDTL ChennaiCDSCO lab |
| Nifedipine Sustain Release Tablets I.P. 20 mg | Batch T230307Mfg Mar 2023 · Exp Feb 2025 | Medisky Pharmaceuticals Pvt. LtdGujarat | DissolutionDissolution | CDL KolkataCDSCO lab |
| Nicomode-2 (Nicoumalone Tablets IP 2 mg) | Batch T222932Mfg Feb 2023 · Exp Jan 2025 | United Bioceuticals Pvt. LtdUttarakhand | Related SubstancesRelated substances | CDL KolkataCDSCO lab |
| Mupirocin Ointment IP (MUPIJAI OINTMENT) | Batch 8Mfg Sep 2022 · Exp Aug 2024 | Baxil Pharma Pvt. LtdUttarakhand | Assay of MupirocinAssay | RDTL ChandigarhState lab |
| Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP (Montzer-C) | Batch MTZ2200 3Mfg Dec 2022 · Exp Nov 2024 | Tirupati Medicare LimitedHimachal Pradesh | Dissolution of MontelukastDissolution | CDL KolkataCDSCO lab |
| Misoprostol Tablets I.P. 200 mcg | Batch 22S1GTA, 026Mfg Jan 2022 · Exp Dec 2023 | Synokem Pharmaceuticals LtdUttarakhand | AssayAssay | CDL KolkataCDSCO lab |
| Metronidazole & Ofloxacin Suspension (nor-metrogyl o Suspension) | Batch XSWN22 006Mfg Apr 2022 · Exp Mar 2024 | Hema Laboratories Pvt LtdUttarakhand | ASSAY OF METRONIDAZOLE BENZOATE AND OFLOXACINAssay | CDTL ChennaiCDSCO lab |
| Methylprednisolone Sodium Succinate for Injection USP 40mg | Batch 22MS03Mfg Nov 2023 · Exp Oct 2024 | SAI Parenterals LimitedTelangana | Uniformity of Dosage Units, Loss on Drying & Assay of Methylprednisolone Sodium SuccinateAssay | CDL KolkataCDSCO lab |
| Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP (GLIMESTAR� M2 FORTE) | Batch P9IAV007Mfg Nov 2022 · Exp Oct 2024 | MANKIND PHARMA LTD. Doring BlockSikkim | Disintegration and DissolutonDisintegration | RDTL GuwahatiState lab |
| MOL-PCB Syrup (Paracetamol, Bromhexine Hydrobromide Chlorpheniramine Maleate, Phenylephrine Hydrochloride, Menthol Syrup) ? 60 ml | Batch L22541Mfg Mar 2023 · Exp Feb 2025 | Aan Pharma Private Limited | pH, Assay of Bromhexine Hydrobromide and Phenylephrine HydrochlorideAssay | CDL KolkataCDSCO lab |
| Lorazepam Tablets I.P. 2 mg | Batch LZMT100 6Mfg Feb 2023 · Exp Jan 2025 | Unicure India LtdUttar Pradesh | Dissolution and AssayAssay | CDTL MumbaiCDSCO lab |
| Levocetirizine and Amrboxol Syrup (C & C Syrup) | Batch BL23015Mfg Feb 2023 · Exp Jan 2025 | Baxil Pharma Pvt. LtdUttarakhand | Assay of Ambroxol HydrochlorideAssay | RDTL ChandigarhCDSCO lab |
| Ibuprofen and Paracetamol Dispersible Tablets (Ibucon Plus Kid) | Batch C211143 003Mfg Mar 2023 · Exp Feb 2026 | Concept Pharmaceuticals Ltd | Diameter & Uniformity of DispersionUniformity of weight/content | CDTL MumbaiCDSCO lab |
| GENTAMYCIN INJECTION I.P. (GENTAVIK 2ml.) | Batch TGL0223 0318Mfg Feb 2023 · Exp Jan 2025 | T & G MedicareHimachal Pradesh | Sterillity and Bacterial Endotoxins TestBacterial endotoxins | RDTL GuwahatiState lab |
| Frusemide Injection IP (2ml) | Batch AI22236Mfg Aug 2022 · Exp Jul 2024 | Alves Healthcare Private LimitedHimachal Pradesh | pHpH | CDL KolkataCDSCO lab |
| Esylate (Etamsylate Injection 250 mg) | Batch I-2359Mfg Dec 2021 · Exp Nov 2023 | Jackson Laboratories Pvt. LtdPunjab | Description, Particulate Matter & Extractable VolumeDescription | CDL KolkataCDSCO lab |
| Erythromycin Stearate Tablets IP 250 mg | Batch AT23118Mfg Apr 2023 · Exp Mar 2025 | Alves Healthcare Private LimitedHimachal Pradesh | DissolutionDissolution | CDL KolkataCDSCO lab |
| Erythromycin Stearate Tablets (Enthrocin-500) | Batch ATG3A04 8Mfg Jan 2023 · Exp Dec 2024 | Anrose PharmaHimachal Pradesh | DissolutionDissolution | CDL KolkataCDSCO lab |
| Doxycycline and Lactic Acid Bacillus Capsules(DOXORIA-L) | Batch SOC- 2062AMfg Nov 2022 · Exp Oct 2024 | Symbiosis Pharmaceuticals Pvt. LtdHimachal Pradesh | Assay /Content of Gram positive rod shaped spore forming bacteriaAssay | CDL KolkataCDSCO lab |
| Diclofenac Prolonged- Release Tablets IP 100 mg | Batch CHT- 3037Mfg Jan 2023 · Exp Dec 2024 | Cotec Healthcare Pvt. LtdUttarakhand | DissolutionDissolution | RDTL ChandigarhCDSCO lab |
| DICLOGLOBE 50 (Diclofenac Sodium Tablets I.P. 50 mg) | Batch GT23026Mfg Jan 2023 · Exp Dec 2025 | Globela Pharma Pvt. LtdGujarat | DisintegrationDisintegration | CDL KolkataCDSCO lab |
| CyproheptadineHCl with Tricholine Citrate Syrup (Sylpro Plus Syrup) | Batch 33002Mfg May 2023 · Exp Apr 2025 | Norris Medicines LimitedGujarat | Assay of TricholineCitrate.This sample is found to contain Diethylene Glycol 0.243%w/v and Ethylene Glycol 0.171%w/vAssay | CDL KolkataCDSCO lab |
| Ciprofloxacin Hydrochloride Tablets IP 500 mg | Batch 700323Mfg Feb 2023 · Exp Jan 2025 | Karnataka Antibiotics & Pharmaceuticals LtdKarnataka | TEST FOR DISSOLUTIONDissolution | CDTL ChennaiCDSCO lab |
| Cefpodoxime Proxetil for Oral Suspension IP | Batch UCST- 2310Mfg Mar 2023 · Exp Feb 2025 | Ultra Drugs Pvt. LtdHimachal Pradesh | pHpH | RDTL ChandigarhCDSCO lab |
| Cefotaxime for Injection IP 500 mg | Batch CD22002Mfg Mar 2022 · Exp Feb 2024 | Maan Pharmaceuticals LtdGujarat | Particulate Matter & Clarity of SolutionParticulate matter | CDL KolkataCDSCO lab |
| Cefoperazone & Sulbactam for injection | Batch S3A099Mfg Jan 2023 · Exp Dec 2024 | Arion HealthcareHimachal Pradesh | Assay of SulbactamAssay | CDL KolkataCDSCO lab |
| Calcium and Vitamin D3 Tablets I.P. | Batch KTB2176 ALMfg Nov 2022 · Exp Apr 2024 | Karnataka Antibiotics & Pharmaceuticals LtdKarnataka | Uniformity of content for Vitamin D3Uniformity of weight/content | CDTL MumbaiCDSCO lab |
| Calamine, Zinc Oxide, Aloe vera & Light Liquid Paraffin (Calmin Lotion) | Batch C-012Mfg Apr 2022 · Exp Mar 2025 | Gladios Products Pvt LtdGujarat | Specific gravityOther | CDTL MumbaiCDSCO lab |
| COMPOUND SODIUM LACTATE INJECTION I.P. | Batch 03BF173, 7Mfg Aug 2022 · Exp Jul 2025 | Paschim Banga Pharmaceuticals | Bacterial Endoxtoxins TestOther | RDTL GuwahatiState lab |
| CALCIUM ACETATE TABLETS USP 667 mg., (Lanum) | Batch D222313Mfg Jul 2022 · Exp Jun 2025 | Standford Laboratories Private Limited | AssayAssay | RDTL GuwahatiState lab |
| Bacillus Clausii Spores Suspension (EbaniproSuspension) | Batch AFL2258 8Mfg Aug 2022 · Exp Jul 2024 | Aarmed Formulation Pvt. LtdGujarat | Purity & Specified Pathogen (Pseudomonas aeruginosa)Other | CDL KolkataCDSCO lab |
| Aspirin Gastro-resistant and Atorvastatin Capsules IP (75mg/10mg) | Batch 54CAT09, 6Mfg Sep 2022 · Exp Aug 2024 | Swiss Garnier Life SciencesHimachal Pradesh | Dissolution (buffer stage) of Aspirin and The Assay of Atrovastatin Calcium calculated as AtorvastatinAssay | RDTL ChandigarhCDSCO lab |
| Amoxycillin Capsules IP 500 MG (AMOXYCILLIN 500) | Batch C-5076Mfg Oct 2022 · Exp Sep 2024 | Jackson Laboratories Pvt. LtdPunjab | TEST FOR DISSOLUTIONDissolution | CDTL ChennaiCDSCO lab |
| AMTAS PRP (Amlodipine and Perindopril Tablets) | Batch K2200008 2Mfg Jan 2022 · Exp Dec 2024 | Intas Pharmaceuticals LtdSikkim | Assay of Perindopril ErbumineAssay | CDL KolkataCDSCO lab |
| (Absorbable Surgical Suture U.S.P (synthetic) 70 cm), (Monofilament Poliglecaprone 25) (STERGIC) | Batch TV22212 7Mfg Sep 2022 · Exp Aug 2025 | Sugii Surgical India Pvt. LtdKarnataka | DiameterOther | CDL KolkataCDSCO lab |
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Changelog
- 3 Nov 2026: table generated from the CDSCO NSQ portal export (48 rows). Revised CDSCO lists are diffed on each monthly rebuild.