CDSCO monthly lab alert
CDSCO NSQ alert, May 2024: 52 drug batches flagged
By Blacklisted editorial team· Published 20 Jun 2024· Updated 20 Sep 2026· Source: CDSCO NSQ portal
In its May 2024 alert, the Central Drugs Standard Control Organisation listed 52 drug batches that failed quality tests, 39 at central laboratories and 13 at state drug-testing laboratories, from 48 manufacturers across 49 products. The most common failure was assay, and the most-represented manufacturing state was Himachal Pradesh. Products flagged include Pantoprazole Tablets I.P.., XERONAC-SP Tablets, Aceclofenac, Paracetamol &, Vildagliptinand Metformin Hydrochloride Tablets IP 50mg/1000mg.
52
Batches flagged
39 / 13
Central / state labs
Assay
Top reason
48
Manufacturers
Batches per month, last 12 alerts
Jun 2023May 2024 · 52
Full list of NSQ batches, May 2024
Download CSV| Product | Batch | Manufacturer | Reason declared NSQ | Tested by |
|---|---|---|---|---|
| XERONAC-SP Tablets, Aceclofenac, Paracetamol & | RP-T243/CMfg 2023-12 · Exp 2025-11 | Roma Pharma Pvt.LtdHimachal Pradesh | MISBRANDED The label of the drug does not indicate the comon name of the colur used as requied as per Rule 127(2)Misbranded | State Lab Drugs Control Laboratory, TelanganaState lab |
| Vildagliptinand Metformin Hydrochloride Tablets IP 50mg/1000mg | VMC04G 23AMfg 2023-10 · Exp 2025-09 | Bajaj Healthcare LtdGujarat | The sample does not conform to IP with respect to the test for Dissolution and Assay of Vildagliptin.Assay | CDL KolkataCDSCO lab |
| Tolcenta-P Tablets, | ZT22806Mfg 2022-12 · Exp 2024-11 | Zenomed Health Care Pvt.Ltd. (ISO & | NOT OF STANDARD QUALITYOther | State Lab Drugs ControlState lab |
| Terbutaline Sulphate, Bromhexine Hydrochloride, Guaiphenesinand Menthol Syrup | 23D-20Mfg 2023-04 · Exp 2025-03 | RADICALS PHARMAPVT. LTDDelhi | The sample does not conforms to claim as per Patent and Proprietary (RDTL/MS/3286)in respect to the Assay of Terbutaline Sulphate, Bromhexine HydrochlorideAssay | RDTL ChandigarhCDSCO lab |
| Terbutaline Sulfate,Bromhexin e Hydrochloride with Guaiphenesin Syrup | VS16010Mfg 2024-01 · Exp 2026-12 | Priya Life Science | The sample does not conform to Manufacturer's Specification with respect to the Assay of Bromhexine Hydrochloride and Terbutaline Sulphate.Assay | CDL KolkataCDSCO lab |
| TELMISARTAN ANDAMLODIPINE TABLETS IP | TE3016AMfg 2023-05 · Exp 2025-04 | NavkarLifesciencesHimachal Pradesh | The sample received DOES NOT CONFORM toI.P.2022Specification with respect to the test parameters Dissolution and Assay of Amlodipine Besylate equivalent to Amlodipinecontentonly. CDTLHREPORTNO.: CDTLH/1510/F- 1068/2023-24Assay | CDTL HyderabadCDSCO lab |
| TELMISARTAN AND METOPROLOL SUCCINATE (EXTENDED RELEASE) TABLETS | BD23178 0HMfg 2023-12 · Exp 2025-11 | BIOALTUS PHARMACEUTICA LS PRIVATE LIMITEDHimachal Pradesh | NOTE: THE SAMPLE RECEIVED DOES NOT CONFORM TO MANUFACTURERS SPECIFICATION WITH RESPECT TO THE TEST FOR DISSOLUTION FOR THE CONTENT OF METOPROLOL SUCCINATE EQUIVALENT TO METOPROLOL TARTRATE(EXTENDED RELEASE) AT THE FINAL TEST TIME (20th HOUR) OF L1+L2+L3 LEVEL ONLY. CDTLHREPORTNO.: CDTLH/1527/F-Dissolution | CDTL HyderabadCDSCO lab |
| Sif Alben Suspension, Albendazole Oral Suspension 2.5% w/v (Vet) | AL80012 3Mfg 2023-05 · Exp 2025-04 | Siflon Drugs & Pharmaceuticals Pvt.LtdTelangana | MISBRANDED The given sample Albendazole oral suspension is official included in the IP and required as per schedule of the Drugs and Cosmetics Act 1940. The given sample shall comply with the standards set out in IP but, the designation IP is conjunction with the official tittle Albendazoleoral suspension on label of the drug product was not mentioned as indication that the drug product purports to comply with IP standards. Hence the Drug product shall be deemed to be Misbranded drug as per section 17 of Drugs and Cosmetics Act.Misbranded | State Lab Drugs Control Laboratory, TelanganaState lab |
| Ramipril & Hydrochlorthiazide Tablets IP | PT- 31954Mfg 2023-07 · Exp 2025-06 | PharmarootsHealthcareHimachal Pradesh | The sample received does not conform to the I.P.2022standardwith respect to the test for assay of Ramipril. Note:-Other test could not be done due to technical reasonAssay | CDTL MumbaiCDSCO lab |
| Rabedin tablet Tablets, Rabeprazole Sodium Gastro-Resistant Tabelts IP, | LV23HT-034BMfg 2023-08 · Exp 2025-01 | LV life Sciences VPO GurumajraHimachal Pradesh | NOT OF STANDARD QUALITY The sample does not meet the acid stage acceptance criteria as per IP specifications, hence it is declared as NOT OF STANDARD QUALITY.Other | State Lab Drugs Control Laboratory, TelanganaState lab |
| Prednisolone TabletsIP10mg | PRDT- 1007Mfg 2022-11 · Exp 2024-10 | WINGSBIOTECH LLPHimachal Pradesh | The sample does not conforms to claim as per IP 2018 and Addendum 2021 in respect to the Assay of PrednisoloneAssay | RDTL ChandigarhCDSCO lab |
| Paracetamol 500 mg. Tablets | PAR-31Mfg 2023-08 · Exp 2026-07 | ASKON HEALTH CARE | The sample Does not Complies conforms to I.P. with respect to the above tests only.Other | RDTL GuwahatiCDSCO lab |
| Pantoprazole Tablets I.P.. | PAA-507Mfg 2023-06 · Exp 2025-05 | Healers LabHimachal Pradesh | The sample Does not complies conforms to Manufacturer Specification with respect to the above tests only.Other | RDTL GuwahatiCDSCO lab |
| Pantoprazole Tablets I.P.. | PAA-507Mfg 2023-06 · Exp 2025-05 | Healers LabHimachal Pradesh | The sample Does not complies conforms to Manufacturer Specification with respect to the above tests only.Other | RDTL GuwahatiCDSCO lab |
| Oxifer-XT Tablets, Ferrous ascorbate elemental iron, Folic acid & Zinc sulphate Tablets, | EOX 2306Mfg 2023-12 · Exp 2025-05 | Eminent Remedies Plot No. 9/1/ATelangana | NOT OF STANDARD QUALITY Sample does not meets the Specifications wrt Assay of elemental Iron (Ferrous Ascorbate).Assay | State Lab Drugs Control Laboratory, TelanganaState lab |
| Ofloxacin Ornidazole Tablets IP | AD24059Mfg 2024-04 · Exp 2026-03 | Skymap Pharmaceuticals Pvt. LtdUttarakhand | Note: the sample received does not conformtoi.p.2022 specification with respect to the test for dissolution for the content of ofloxacin and ornidazole ( s1, s2 and s3 level) only. Cdtlh report no.: cdtlh/0131/f -Dissolution | CDTL HyderabadCDSCO lab |
| Nagris Pakeezah Art Henna (3 Henna Cones) | -Mfg ? · Exp ? | Nagris HerbsTelangana | NOT OF STANDARD QUALITY A. The sample does not conform to the test for determination of absence of Picramic Acid as per BIS standard IS 17318:2020 as required as per rule 39 (Standard of Cosmetics) 2020. B. As the cautions do not use for coluring eyelashes or eyebrows. Do not use on cut, Irritated or abranded skin as per Bis Standard IS 17318: 2020 is not mentioned on the label of the cosmetic sample. Hence, the sample not labeled in the prescribed manner and deemed to be Misbranded Cosmetics asMisbranded | State Lab Drugs Control Laboratory, TelanganaState lab |
| Moxtas Distab 250 Tablets, Amoxycillin trihydrate dispersible tablets IP. | MALT-2019Mfg 2023-10 · Exp 2025-09 | Wings Novitas Healthcare LLP 43 & 44Himachal Pradesh | NOT OF STANDARD QUALITY Tablets are with uneven surface and are crumbling while taking out of the strip. Hence failed with respect to the test Description of Tablets.Description | State Lab Drugs Control Laboratory, TelanganaState lab |
| Montelukast Sodium & Levocetirizine Hydrochloride Tablets | ATA-176Mfg 2023-02 · Exp 2025-01 | Alliaance BiotechHimachal Pradesh | The sample does not conform to I.P. with respect to the above tests only.Other | RDTL GuwahatiCDSCO lab |
| Metronidazole Extended Release Tablets USP 600 MG | TC- 060323Mfg 2023-03 · Exp 2025-02 | Technica Lab & Pharma Pvt.LimitedUttarakhand | The sample does not conform to U.S.P with respect to the test of Dissolution.Dissolution | CDL KolkataCDSCO lab |
| Mecobalamin, AlphaLipoicAcid, Pyridoxine Hydrochlorideand Folic Acid Soft Gelatin Capsules | DBIS- 8591Mfg 2023-11 · Exp 2025-10 | Broad Injectables | The sample does not conforms to claim as per Schedule V of Drugs and Cosmetics Act with respect to the Assay/content of Mecobalamin and PyridoxineHydrochlorideAssay | CDL KolkataCDSCO lab |
| Meazon Plus injection Parentaral Preparations, Mecobalamine, Folic acid & Niacianamideinj 1 ml, | 23MP07Mfg 2023-10 · Exp 2025-09 | Sai parentrals limited D1&D4Telangana | NOT OF STANDARD QUALITY Sample does not comply Assay of Folic Acid.Assay | State Lab Drugs Control Laboratory, TelanganaState lab |
| METOPROLOL SUCCINATE EXTENDED RELEASE TABLETS IP | GT3J026Mfg 2023-10 · Exp 2025-09 | Scott-Edil PharmaciaLtdHimachal Pradesh | The sample does not conforms to claim as per I.P.2022inrespectto the Test of Dissolution (1Hr),Dissolution(4 Hours)Dissolution | CDL KolkataCDSCO lab |
| LevosalbutamolSul phate,AmbroxolHC L,Guaiphenesin Syrup | 5346Mfg 2024-03 · Exp 2026-02 | Esquire Drug HouseGujarat | The sample does not conform to claim as per Schedule V of Drugs & Cosmetics Act with respect to Assay of Levosalbutamol Sulphate Equivalent to Levosalbutamol. NB:The sample does not give positive test for Diethylene glycol and is found to contain 0.0071 % w/v Ethylene glycol; (Limit NMT 0.1% w/v, Method: GC, Ref: USP under the monograph of Propylene glycol,)Assay | CDL KolkataCDSCO lab |
| Levolets- M Kid Syrups, Montelukast Sodium & Levocetrizine Dihydrochloride syrup | RC24BL-521Mfg 2024-02 · Exp 2026-01 | Rikencare Life sciences villmessaTibbaHimachal Pradesh | NOT OF STANDARD QUALITY Sample does not comply Description of syrup and Assay of Montelukast.Assay | State Lab Drugs Control Laboratory, TelanganaState lab |
| LactuloseSolution U.S.P. | GA2312 7Mfg 2023-11 · Exp 2025-10 | Skymap Pharmaceuticals Pvt. LtdUttarakhand | The sample does not conforms to claim as per U.S.P.in respect to the Assay.Assay | CDL KolkataCDSCO lab |
| Gentamicin Sulphate Injection I.P. 2ml | 323-216Mfg 2023-03 · Exp 2025-02 | ZEE LABORATORIES LTDHimachal Pradesh | The sample does not conforms to I.P. with respect to the test for "Particulate matter" and is also not of standard quality for the reason stated under "Description"Description | CDL KolkataCDSCO lab |
| GLIPIZIDEAND METFORMIN TABLETS IP | 4010026Mfg 2023-11 · Exp 2025-04 | USV Private LimitedKarnataka | The sample does not conform to claim I.P. with respect to the test for Dissolution of GlipizideDissolution | CDL KolkataCDSCO lab |
| Fluconazole Tablets IP (150 mg).. | UGT233 38Mfg 2023-03 · Exp 2025-02 | Unimark Healthcare LtdUttarakhand | The sample received does not conform to the I.P.2022 standard with respect to the test for Related substances.Related substances | CDTL MumbaiCDSCO lab |
| DofloxOZT Tablets, Ofloxacin&Ornid azole Tablets | DDX230 1Mfg 2023-06 · Exp 2026-05 | Doctor's Vet-Pharma Pvt.LtdAndhra Pradesh | MISBRANDED The drug product Ofloxacin and Ornidazole Tablets is official in Indian Pharmacopoeia. But the letters IP is not mentioned on the strip after the product name Ofloxacin and Ornidazole Tablets.Misbranded | State Lab Drugs Control Laboratory, TelanganaState lab |
| Disinfectants, Surgical Spirit BP | SS-053011Mfg 2023-05 · Exp 2025-04 | TransflexjawaharnagarChhattisgarh | MISBRANDED As per rule R.124 the drug is included in the current edition of Indian Pharmacopoiea 2022. Hence standards shall be of those as specified in Indian Pharmacopoiea 2022. But the subject drug Surgical spirit bears the letters B.P after the drug name instead of IP. As per rule 96 and 104 as the drug shall be in accordance with standards set out in Indian Pharmaopoiea, the name of the drug surgical spirit shall be followed by the letters IP. As the subject drug is not confirming to the said labelling requirements the drug shall be deemed to be Misbranded as per section 17.Misbranded | State Lab Drugs Control Laboratory, TelanganaState lab |
| Diclofenac Sodium and Paracetamol Tablets IP | RCT230 50Mfg 2023-06 · Exp 2026-02 | Galpha Laboratories LimitedHimachal Pradesh | The sample does not conforms to claim as per IP in respect to the Test of DescriptionDescription | CDL KolkataCDSCO lab |
| Dexamethasone Sodiumphosphate Injection IP | DX-2305Mfg 2023-05 · Exp 2025-04 | Konis Pharmaceuticals | The sample does not conforms to claim as per IP2022 in respect to the Test of Description and Particulate matterDescription | CDL KolkataCDSCO lab |
| Dexamethasone SodiumPhosphate Injection I.P | DSA123 13Mfg 2023-07 · Exp 2025-06 | Nandani Medical Laboratories Pvt. LtdMadhya Pradesh | The sample does not conforms to IP with respect to Assay/ content of Dexamethasone PhosphateAssay | CDL KolkataCDSCO lab |
| Dexamethasone Sodium Phosphate Injection I.P. (8mg/2ml) | 323-885Mfg 2023-08 · Exp 2025-07 | ZEE LABORATORIES LTDHimachal Pradesh | The sample does not conforms to IP with respect to test for "Free Dexamethasone", "Particulate matter,", "Extractable volume" ,"Assay of Dexamethasone Sodium Phosphate calculated as Dexamethasone Phosphate" and is also not of standard quality for the reason stated under "Description".Assay | CDL KolkataCDSCO lab |
| Cyra Tablets, Rabeprazole Sodium Tablets IP | CA21868Mfg 2023-07 · Exp 2025-06 | Mepro Pharmaceuticals Pvt.Ltd | NOT OF STANDARD QUALITY The tablets does not complies in buffer stage for the dissolution test parameter, hence it is NOT OF STANDARD QUALITY.Dissolution | State Lab Drugs Control Laboratory, TelanganaState lab |
| Cuftin COUGH LINCTUS | ECT- 2421Mfg 2023-09 · Exp 2025-08 | ELFOS LABORATORIESRajasthan | The sample does not conforms to claim as per Patent and Proprietary in respect to the Assay of Sodium CitrateAssay | RDTL ChandigarhCDSCO lab |
| Clonazepam TabletsI.P.0.5mg | 04L23T0 3Mfg 2023-12 · Exp 2026-11 | Shine Pharmaceuticals LimitedGujarat | The sample does not conforms to claim as per IP in respect to The Test of Related SubstancesRelated substances | CDL KolkataCDSCO lab |
| CefuroximeAxetil Tablets IP | DB23030 4Mfg 2023-12 · Exp 2025-11 | Daxin Pharmaceuticals Pvt.LtdHimachal Pradesh | The sample does not conforms to claim as per IP 2022in respect to the Test of Dissolution of Cefuroxime Axetil equivalent to CefuroximeDissolution | CDL KolkataCDSCO lab |
| Ceftriaxone for InjectionI.P.1gm | DC3011 9Mfg 2023-10 · Exp 2025-09 | Captab BiotecHimachal Pradesh | The sample does not conforms to I.P. with respect to test for "Particulate MatterParticulate matter | CDL KolkataCDSCO lab |
| Ceftriaxone Injection IP | C2402- 02FMfg 2024-02 · Exp 2026-01 | Integrated Laboratories Pvt. LtdHimachal Pradesh | The sample does not conform to IP with respect to the Particulate matter, Clarity of Solution and for the reason stated under DescriptionDescription | CDL KolkataCDSCO lab |
| Ceftriaxone Injection I.P | 324-166Mfg 2024-02 · Exp 2026-07 | Zee Laboratories LimitedHimachal Pradesh | The sample does not complies to claim as per IP 2022in respect of test for appearance of solution, clarity of solution, particulate matter and sterility (Powder for Injection).Sterility | CDL KolkataCDSCO lab |
| Cefotaxime InjectionIP500mg | CTI2308 1Mfg 2023-08 · Exp 2025-01 | Vivek Pharmachem (India) LtdRajasthan | The sample does not conforms to I.P. with respect to the Test for 'Related Substances', 'Particulate matter' and 'Clarity of solution'Particulate matter | CDL KolkataCDSCO lab |
| Cefoperazone& Sulbactam for Injection | B- 22680DMfg 2023-01 · Exp 2024-12 | Pace BiotechHimachal Pradesh | The sample does not conforms to claim as per The Schedule V of The Drugs and Cosmetics Act,1940withrespectto the Test for 'Clarity of solution' and' Particulate matter'Particulate matter | CDL KolkataCDSCO lab |
| Cefixime & Ofloxacin Tablets | DB23005 7Mfg 2023-02 · Exp 2025-01 | Daxin Pharmaceuticals Pvt.LtdHimachal Pradesh | The sample does not conforms to claim as per Schedule V of Drugs & Cosmetics Act with respect to the Assay of Cefixime Trihydrate eq. to anhydrous Cefixime and Assay of OfloxacinAssay | CDL KolkataCDSCO lab |
| Calcium 500 mg withVitaminD3250 IU Tablets IP | LMT240 263Mfg 2023-03 · Exp 2026-02 | Life Max Cancer LaboratoriesUttarakhand | The sample Does not Complies conforms to I.P. with respect to the above tests only.Other | RDTL GuwahatiCDSCO lab |
| Atropine Sulphate Injection IP | 23UG18Mfg 2023-07 · Exp 2025-06 | SVP LIFE SCIENCESUttarakhand | The sample does not conforms to claim as per IP2022in respect to the Test of pH and Assay of Atropine SulphateAssay | RDTL ChandigarhCDSCO lab |
| Amoxycillin&Potas sium Clavulanate InjectionIP1.2gm | 23AP04Mfg 2023-05 · Exp 2025-04 | SAI Parenterals LimitedTelangana | The sample does not conforms to claim as per I.P. 2022 in respect to the Test of Clarity of solution and Assay of Potassium Clavulanate calculated as Clavulanic AcidAssay | CDL KolkataCDSCO lab |
| Amoxycillin & Potassium Clavulanate Tablets I.P.. | TCV- 2303003Mfg 2023-03 · Exp 2025-02 | Rivpra FormulationPvt.LtdUttarakhand | The sample does not conform to I.P. with respect to the test for Assay.Assay | RDTL GuwahatiCDSCO lab |
| Ambroxol HCl, Levosalbutamoland Guaiphenesin Syrup | VDL- 1240Mfg 2022-07 · Exp 2024-06 | VVPB Pharmaceuticals Pvt. LtdHimachal Pradesh | The sample does not conforms to claim as per Patent and Proprietary in respect to the Test of Diethylene Glycol (DEG) and Assay of Ambroxol HydrochlorideAssay | RDTL ChandigarhCDSCO lab |
| Acetylsalicylic Acid Tablets 75 mg | JTN23- 211Mfg 2023-07 · Exp 2026-06 | AK Krishna Pharma Pvt.LtdUttarakhand | Sample does not conforms to IP with respect to test for Dissolution.Dissolution | CDL KolkataCDSCO lab |
| . Pedxim-200 Tablets, Cefpodoximepro xetil Tablets 200 mg, | TBL-2676Mfg 2023-04 · Exp 2025-03 | Ticomapharmaciae-17 Focal PontPunjab | MISBRANDED The product name (title) indicated on the label is as CefpodoximeProxetil Tablets 200 mg instead of CefpodoximeProxetil Dispersible Tablets 200 mg. The label of the product does not state that the tablets should be dispersed in water immediately before use. Hence the product is not labeled in the prescribed manner and is deemed to be Misbranded drug as per section 17(c) of Drugs and Cosmetics Act.Water content | State Lab Drugs Control Laboratory, TelanganaState lab |
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Changelog
- 20 Sep 2026: table generated from the CDSCO NSQ portal export (52 rows). Revised CDSCO lists are diffed on each monthly rebuild.