CDSCO monthly lab alert
CDSCO NSQ alert, August 2023: 48 drug batches flagged
By Blacklisted editorial team· Published 20 Sep 2023· Updated 20 Sep 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), | 23009Mfg 2023-01 · Exp 2024-10 | 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) | 312053KJ M1Mfg 2023-03 · Exp 2028-02 | Hindustan Syringes & Medical Devices LtdHaryana | Design (Piston/Plunger Assembly) Fit of piston in barrelOther | RDTL ChandigarhCDSCO lab |
| Telmisartan and Chlorthalidone Tablets | PF8C006Mfg 2022-09 · Exp 2024-08 | Pure & Cure Healthcare Pvt. LtdUttarakhand | Dissolution of ChlorthalidoneDissolution | CDL KolkataCDSCO lab |
| Sterile Noradrenaline Concentrate IP (2mg /1ml) | INABB23 01Mfg 2023-04 · Exp 2025-03 | Samarth Life Sciences Pvt. LtdHimachal Pradesh | Description & Particulate MatterDescription | CDL KolkataCDSCO lab |
| Sibolone (Tibolone Tablets IP) | PLSB230 1Mfg 2023-02 · Exp 2025-09 | Phaarmasia Ltd | DissolutionDissolution | CDL KolkataCDSCO lab |
| Selamer-400 Tablets (Sevelamer Carbonate Tablets 400 mg) | MT22612 4BMfg 2022-12 · Exp 2024-11 | Mascot Health Series Pvt. LtdUttarakhand | DescriptionDescription | CDL KolkataCDSCO lab |
| Refined Glycerin CP Grade | 21100637Mfg 2022-10 · Exp 2025-09 | 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) | RBL2202 0RHMfg 2022-10 · Exp 2024-09 | Ravian Life Science Pvt. LtdUttarakhand | DissolutionDissolution | RDTL GuwahatiState lab |
| Povidone-Iodine Ointment USP 5% w/w | P1040Mfg 2022-08 · Exp 2025-07 | 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) | SF001A0 1Mfg 2022-01 · Exp 2024-12 | 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) | SF001B0 1Mfg 2022-02 · Exp 2025-01 | 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) | SF001A0 2Mfg 2022-01 · Exp 2024-12 | 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) | BBT2217 94Mfg 2022-05 · Exp 2024-04 | Biomax Biotechnics (P) LtdHaryana | DissolutionDissolution | RDTL GuwahatiState lab |
| Ofloxacin & Metronidazole Benzoate Suspension (VIVFLOX-MZ Suspension) (For Paediatric USE ONLY) | PFS-1204Mfg 2022-11 · Exp 2024-10 | Proceed FormulationsPunjab | ASSAY OF METRONIDAZOLE BENZOATE AND OFLOXACINAssay | CDTL ChennaiCDSCO lab |
| Nifedipine Sustain Release Tablets I.P. 20 mg | T230307Mfg 2023-03 · Exp 2025-02 | Medisky Pharmaceuticals Pvt. LtdGujarat | DissolutionDissolution | CDL KolkataCDSCO lab |
| Nicomode-2 (Nicoumalone Tablets IP 2 mg) | T222932Mfg 2023-02 · Exp 2025-01 | United Bioceuticals Pvt. LtdUttarakhand | Related SubstancesRelated substances | CDL KolkataCDSCO lab |
| Mupirocin Ointment IP (MUPIJAI OINTMENT) | 8Mfg 2022-09 · Exp 2024-08 | Baxil Pharma Pvt. LtdUttarakhand | Assay of MupirocinAssay | RDTL ChandigarhState lab |
| Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP (Montzer-C) | MTZ2200 3Mfg 2022-12 · Exp 2024-11 | Tirupati Medicare LimitedHimachal Pradesh | Dissolution of MontelukastDissolution | CDL KolkataCDSCO lab |
| Misoprostol Tablets I.P. 200 mcg | 22S1GTA 026Mfg 2022-01 · Exp 2023-12 | Synokem Pharmaceuticals LtdUttarakhand | AssayAssay | CDL KolkataCDSCO lab |
| Metronidazole & Ofloxacin Suspension (nor-metrogyl o Suspension) | XSWN22 006Mfg 2022-04 · Exp 2024-03 | Hema Laboratories Pvt LtdUttarakhand | ASSAY OF METRONIDAZOLE BENZOATE AND OFLOXACINAssay | CDTL ChennaiCDSCO lab |
| Methylprednisolone Sodium Succinate for Injection USP 40mg | 22MS03Mfg 2023-11 · Exp 2024-10 | 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) | P9IAV007Mfg 2022-11 · Exp 2024-10 | 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 | L22541Mfg 2023-03 · Exp 2025-02 | Aan Pharma Private Limited | pH, Assay of Bromhexine Hydrobromide and Phenylephrine HydrochlorideAssay | CDL KolkataCDSCO lab |
| Lorazepam Tablets I.P. 2 mg | LZMT100 6Mfg 2023-02 · Exp 2025-01 | Unicure India LtdUttar Pradesh | Dissolution and AssayAssay | CDTL MumbaiCDSCO lab |
| Levocetirizine and Amrboxol Syrup (C & C Syrup) | BL23015Mfg 2023-02 · Exp 2025-01 | Baxil Pharma Pvt. LtdUttarakhand | Assay of Ambroxol HydrochlorideAssay | RDTL ChandigarhCDSCO lab |
| Ibuprofen and Paracetamol Dispersible Tablets (Ibucon Plus Kid) | C211143 003Mfg 2023-03 · Exp 2026-02 | Concept Pharmaceuticals Ltd | Diameter & Uniformity of DispersionUniformity of weight/content | CDTL MumbaiCDSCO lab |
| GENTAMYCIN INJECTION I.P. (GENTAVIK 2ml.) | TGL0223 0318Mfg 2023-02 · Exp 2025-01 | T & G MedicareHimachal Pradesh | Sterillity and Bacterial Endotoxins TestBacterial endotoxins | RDTL GuwahatiState lab |
| Frusemide Injection IP (2ml) | AI22236Mfg 2022-08 · Exp 2024-07 | Alves Healthcare Private LimitedHimachal Pradesh | pHpH | CDL KolkataCDSCO lab |
| Esylate (Etamsylate Injection 250 mg) | I-2359Mfg 2021-12 · Exp 2023-11 | Jackson Laboratories Pvt. LtdPunjab | Description, Particulate Matter & Extractable VolumeDescription | CDL KolkataCDSCO lab |
| Erythromycin Stearate Tablets IP 250 mg | AT23118Mfg 2023-04 · Exp 2025-03 | Alves Healthcare Private LimitedHimachal Pradesh | DissolutionDissolution | CDL KolkataCDSCO lab |
| Erythromycin Stearate Tablets (Enthrocin-500) | ATG3A04 8Mfg 2023-01 · Exp 2024-12 | Anrose PharmaHimachal Pradesh | DissolutionDissolution | CDL KolkataCDSCO lab |
| Doxycycline and Lactic Acid Bacillus Capsules(DOXORIA-L) | SOC- 2062AMfg 2022-11 · Exp 2024-10 | 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 | CHT- 3037Mfg 2023-01 · Exp 2024-12 | Cotec Healthcare Pvt. LtdUttarakhand | DissolutionDissolution | RDTL ChandigarhCDSCO lab |
| DICLOGLOBE 50 (Diclofenac Sodium Tablets I.P. 50 mg) | GT23026Mfg 2023-01 · Exp 2025-12 | Globela Pharma Pvt. LtdGujarat | DisintegrationDisintegration | CDL KolkataCDSCO lab |
| CyproheptadineHCl with Tricholine Citrate Syrup (Sylpro Plus Syrup) | 33002Mfg 2023-05 · Exp 2025-04 | 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 | 700323Mfg 2023-02 · Exp 2025-01 | Karnataka Antibiotics & Pharmaceuticals LtdKarnataka | TEST FOR DISSOLUTIONDissolution | CDTL ChennaiCDSCO lab |
| Cefpodoxime Proxetil for Oral Suspension IP | UCST- 2310Mfg 2023-03 · Exp 2025-02 | Ultra Drugs Pvt. LtdHimachal Pradesh | pHpH | RDTL ChandigarhCDSCO lab |
| Cefotaxime for Injection IP 500 mg | CD22002Mfg 2022-03 · Exp 2024-02 | Maan Pharmaceuticals LtdGujarat | Particulate Matter & Clarity of SolutionParticulate matter | CDL KolkataCDSCO lab |
| Cefoperazone & Sulbactam for injection | S3A099Mfg 2023-01 · Exp 2024-12 | Arion HealthcareHimachal Pradesh | Assay of SulbactamAssay | CDL KolkataCDSCO lab |
| Calcium and Vitamin D3 Tablets I.P. | KTB2176 ALMfg 2022-11 · Exp 2024-04 | 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) | C-012Mfg 2022-04 · Exp 2025-03 | Gladios Products Pvt LtdGujarat | Specific gravityOther | CDTL MumbaiCDSCO lab |
| COMPOUND SODIUM LACTATE INJECTION I.P. | 03BF173 7Mfg 2022-08 · Exp 2025-07 | Paschim Banga Pharmaceuticals | Bacterial Endoxtoxins TestOther | RDTL GuwahatiState lab |
| CALCIUM ACETATE TABLETS USP 667 mg., (Lanum) | D222313Mfg 2022-07 · Exp 2025-06 | Standford Laboratories Private Limited | AssayAssay | RDTL GuwahatiState lab |
| Bacillus Clausii Spores Suspension (EbaniproSuspension) | AFL2258 8Mfg 2022-08 · Exp 2024-07 | Aarmed Formulation Pvt. LtdGujarat | Purity & Specified Pathogen (Pseudomonas aeruginosa)Other | CDL KolkataCDSCO lab |
| Aspirin Gastro-resistant and Atorvastatin Capsules IP (75mg/10mg) | 54CAT09 6Mfg 2022-09 · Exp 2024-08 | 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) | C-5076Mfg 2022-10 · Exp 2024-09 | Jackson Laboratories Pvt. LtdPunjab | TEST FOR DISSOLUTIONDissolution | CDTL ChennaiCDSCO lab |
| AMTAS PRP (Amlodipine and Perindopril Tablets) | K2200008 2Mfg 2022-01 · Exp 2024-12 | Intas Pharmaceuticals LtdSikkim | Assay of Perindopril ErbumineAssay | CDL KolkataCDSCO lab |
| (Absorbable Surgical Suture U.S.P (synthetic) 70 cm), (Monofilament Poliglecaprone 25) (STERGIC) | TV22212 7Mfg 2022-09 · Exp 2025-08 | Sugii Surgical India Pvt. LtdKarnataka | DiameterOther | CDL KolkataCDSCO lab |
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Official sources and primary records
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Changelog
- 20 Sep 2026: table generated from the CDSCO NSQ portal export (48 rows). Revised CDSCO lists are diffed on each monthly rebuild.