May 2024.51 failed batches.

Batches, by manufacturer

1. UttarakhandAcetylsalicylic Acid Tablets 75 mg · batch JTN23- 211AK Krishna Pharma Pvt.Ltd · Failed: Sample does not conforms to IP with respect to test for Dissolution. · CDL Kolkata
2. Madhya PradeshParacetamol 500 mg. Tablets · batch PAR-31ASKON HEALTH CARE (456010) · Failed: The sample Does not Complies conforms to I.P. with respect to the above tests only. · RDTL Guwahati
3. Himachal PradeshMontelukast Sodium & Levocetirizine Hydrochloride Tablets · batch ATA-176Alliaance Biotech (173205) · Failed: The sample does not conform to I.P. with respect to the above tests only. · RDTL Guwahati
4. Himachal PradeshTELMISARTAN AND METOPROLOL SUCCINATE (EXTENDED RELEASE) TABLETS · batch BD23178 0HBIOALTUS PHARMACEUTICA LS PRIVATE LIMITED (173205) · Failed: 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- · CDTL Hyderabad
5. GujaratVildagliptinand Metformin Hydrochloride Tablets IP 50mg/1000mg · batch VMC04G 23ABajaj Healthcare Ltd (391775) · Failed: The sample does not conform to IP with respect to the test for Dissolution and Assay of Vildagliptin. · CDL Kolkata
6. Himachal PradeshMecobalamin, AlphaLipoicAcid, Pyridoxine Hydrochlorideand Folic Acid Soft Gelatin Capsules · batch DBIS- 8591Broad Injectables (174301) · Failed: 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 PyridoxineHydrochloride · CDL Kolkata
7. Himachal PradeshCeftriaxone for InjectionI.P.1gm · batch DC3011 9Captab Biotec · Failed: The sample does not conforms to I.P. with respect to test for "Particulate Matter · CDL Kolkata
8. Himachal PradeshCefixime & Ofloxacin Tablets · batch DB23005 7Daxin Pharmaceuticals Pvt.Ltd (174103) · Failed: 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 Ofloxacin · CDL Kolkata
9. Himachal PradeshCefuroximeAxetil Tablets IP · batch DB23030 4Daxin Pharmaceuticals Pvt.Ltd (174103) · Failed: The sample does not conforms to claim as per IP 2022in respect to the Test of Dissolution of Cefuroxime Axetil equivalent to Cefuroxime · CDL Kolkata
10. Andhra PradeshDofloxOZT Tablets, Ofloxacin&Ornid azole Tablets · batch DDX230 1Doctor's Vet-Pharma Pvt.Ltd · Failed: 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. · State Lab Drugs Control Laboratory, Telangana.
11. State not givenCuftin COUGH LINCTUS · batch ECT- 2421ELFOS LABORATORIES · Failed: The sample does not conforms to claim as per Patent and Proprietary in respect to the Assay of Sodium Citrate · RDTL Chandigarh
12. TelanganaOxifer-XT Tablets, Ferrous ascorbate elemental iron, Folic acid & Zinc sulphate Tablets, · batch EOX 2306Eminent Remedies (500076) · Failed: NOT OF STANDARD QUALITY Sample does not meets the Specifications wrt Assay of elemental Iron (Ferrous Ascorbate). · State Lab Drugs Control Laboratory, Telangana.
13. GujaratLevosalbutamolSul phate,AmbroxolHC L,Guaiphenesin Syrup · batch 5346Esquire Drug House (363035) · Failed: 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,) · CDL Kolkata
14. Himachal PradeshDiclofenac Sodium and Paracetamol Tablets IP · batch RCT230 50Galpha Laboratories Limited (173205) · Failed: The sample does not conforms to claim as per IP in respect to the Test of Description · CDL Kolkata
15. Himachal PradeshPantoprazole Tablets I.P.. · batch PAA-507Healers Lab · Failed: The sample Does not complies conforms to Manufacturer Specification with respect to the above tests only. · RDTL Guwahati
16. Himachal PradeshCeftriaxone Injection IP · batch C2402- 02FIntegrated Laboratories Pvt. Ltd (173030) · Failed: The sample does not conform to IP with respect to the Particulate matter, Clarity of Solution and for the reason stated under Description · CDL Kolkata
17. Andhra PradeshDexamethasone Sodiumphosphate Injection IP · batch DX-2305Konis Pharmaceuticals (522502) · Failed: The sample does not conforms to claim as per IP2022 in respect to the Test of Description and Particulate matter · CDL Kolkata
18. Himachal PradeshRabedin tablet Tablets, Rabeprazole Sodium Gastro-Resistant Tabelts IP, · batch LV23HT-034BLV life Sciences VPO Gurumajra, BaddiDistt. Solan(H.P)-174101. Himachal Pradesh. Mrkt: Odin Healthcare Pvt.Ltd (174101) · Failed: 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. · State Lab Drugs Control Laboratory, Telangana.
19. UttarakhandCalcium 500 mg withVitaminD3250 IU Tablets IP · batch LMT240 263Life Max Cancer Laboratories (249403) · Failed: The sample Does not Complies conforms to I.P. with respect to the above tests only. · RDTL Guwahati
20. GujaratCyra Tablets, Rabeprazole Sodium Tablets IP · batch CA21868Mepro Pharmaceuticals Pvt.Ltd (363035) · Failed: NOT OF STANDARD QUALITY The tablets does not complies in buffer stage for the dissolution test parameter, hence it is NOT OF STANDARD QUALITY. · State Lab Drugs Control Laboratory, Telangana.
21. State not givenNagris Pakeezah Art Henna (3 Henna Cones) · batch -Nagris Herbs · Failed: 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 as · State Lab Drugs Control Laboratory, Telangana.
22. State not givenDexamethasone SodiumPhosphate Injection I.P · batch DSA123 13Nandani Medical Laboratories Pvt. Ltd · Failed: The sample does not conforms to IP with respect to Assay/ content of Dexamethasone Phosphate · CDL Kolkata
23. Himachal PradeshTELMISARTAN ANDAMLODIPINE TABLETS IP · batch TE3016ANavkarLifesciences · Failed: 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- 1068/2023-24 · CDTL Hyderabad
24. Himachal PradeshCefoperazone& Sulbactam for Injection · batch B- 22680DPace Biotech (173001) · Failed: 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' · CDL Kolkata
25. Himachal PradeshRamipril & Hydrochlorthiazide Tablets IP · batch PT- 31954PharmarootsHealthcare · Failed: 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 reason · CDTL Mumbai
26. State not givenTerbutaline Sulfate,Bromhexin e Hydrochloride with Guaiphenesin Syrup · batch VS16010Priya Life Science · Failed: The sample does not conform to Manufacturer's Specification with respect to the Assay of Bromhexine Hydrochloride and Terbutaline Sulphate. · CDL Kolkata
27. HaryanaTerbutaline Sulphate, Bromhexine Hydrochloride, Guaiphenesinand Menthol Syrup · batch 23D-20RADICALS PHARMAPVT. LTD (133004) · Failed: The sample does not conforms to claim as per Patent and Proprietary (RDTL/MS/3286)in respect to the Assay of Terbutaline Sulphate, Bromhexine Hydrochloride · RDTL Chandigarh
28. Himachal PradeshLevolets- M Kid Syrups, Montelukast Sodium & Levocetrizine Dihydrochloride syrup · batch RC24BL-521Rikencare Life sciences villmessaTibba (174101) · Failed: NOT OF STANDARD QUALITY Sample does not comply Description of syrup and Assay of Montelukast. · State Lab Drugs Control Laboratory, Telangana.
29. UttarakhandAmoxycillin & Potassium Clavulanate Tablets I.P.. · batch TCV- 2303003Rivpra FormulationPvt.Ltd (249403) · Failed: The sample does not conform to I.P. with respect to the test for Assay. · RDTL Guwahati
30. Himachal PradeshXERONAC-SP Tablets, Aceclofenac, Paracetamol & · batch RP-T243/CRoma Pharma Pvt.Ltd (173211) · Failed: MISBRANDED The label of the drug does not indicate the comon name of the colur used as requied as per Rule 127(2) · State Lab Drugs Control Laboratory, Telangana.
31. State not givenAmoxycillin&Potas sium Clavulanate InjectionIP1.2gm · batch 23AP04SAI Parenterals Limited (500055) · Failed: 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 Acid · CDL Kolkata
32. State not givenAtropine Sulphate Injection IP · batch 23UG18SVP LIFE SCIENCES · Failed: The sample does not conforms to claim as per IP2022in respect to the Test of pH and Assay of Atropine Sulphate · RDTL Chandigarh
33. TelanganaMeazon Plus injection Parentaral Preparations, Mecobalamine, Folic acid & Niacianamideinj 1 ml, · batch 23MP07Sai parentrals limited (500055) · Failed: NOT OF STANDARD QUALITY Sample does not comply Assay of Folic Acid. · State Lab Drugs Control Laboratory, Telangana.
34. Himachal PradeshMETOPROLOL SUCCINATE EXTENDED RELEASE TABLETS IP · batch GT3J026Scott-Edil PharmaciaLtd (173205) · Failed: The sample does not conforms to claim as per I.P.2022inrespectto the Test of Dissolution (1Hr),Dissolution(4 Hours) · CDL Kolkata
35. GujaratClonazepam TabletsI.P.0.5mg · batch 04L23T0 3Shine Pharmaceuticals Limited (391240) · Failed: The sample does not conforms to claim as per IP in respect to The Test of Related Substances · CDL Kolkata
36. State not givenSif Alben Suspension, Albendazole Oral Suspension 2.5% w/v (Vet) · batch AL80012 3Siflon Drugs & Pharmaceuticals Pvt.Ltd · Failed: 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. · State Lab Drugs Control Laboratory, Telangana.
37. State not givenLactuloseSolution U.S.P. · batch GA2312 7Skymap Pharmaceuticals Pvt. Ltd (247667) · Failed: The sample does not conforms to claim as per U.S.P.in respect to the Assay. · CDL Kolkata
38. State not givenOfloxacin Ornidazole Tablets IP · batch AD24059Skymap Pharmaceuticals Pvt. Ltd (247667) · Failed: 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 - · CDTL Hyderabad
39. UttarakhandMetronidazole Extended Release Tablets USP 600 MG · batch TC- 060323Technica Lab & Pharma Pvt.Limited · Failed: The sample does not conform to U.S.P with respect to the test of Dissolution. · CDL Kolkata
40. Punjab. Pedxim-200 Tablets, Cefpodoximepro xetil Tablets 200 mg, · batch TBL-2676Ticomapharmaciae-17 Focal Pont (140507) · Failed: 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. · State Lab Drugs Control Laboratory, Telangana.
41. ChhattisgarhDisinfectants, Surgical Spirit BP · batch SS-053011Transflexjawaharnagar (492001) · Failed: 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. · State Lab Drugs Control Laboratory, Telangana.
42. KarnatakaGLIPIZIDEAND METFORMIN TABLETS IP · batch 4010026USV Private Limited (560058) · Failed: The sample does not conform to claim I.P. with respect to the test for Dissolution of Glipizide · CDL Kolkata
43. UttarakhandFluconazole Tablets IP (150 mg).. · batch UGT233 38Unimark Healthcare Ltd (249403) · Failed: The sample received does not conform to the I.P.2022 standard with respect to the test for Related substances. · CDTL Mumbai
44. Himachal PradeshAmbroxol HCl, Levosalbutamoland Guaiphenesin Syrup · batch VDL- 1240VVPB Pharmaceuticals Pvt. Ltd · Failed: 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 Hydrochloride · RDTL Chandigarh
45. RajasthanCefotaxime InjectionIP500mg · batch CTI2308 1Vivek Pharmachem (India) Ltd (303102) · Failed: The sample does not conforms to I.P. with respect to the Test for 'Related Substances', 'Particulate matter' and 'Clarity of solution' · CDL Kolkata
46. Himachal PradeshPrednisolone TabletsIP10mg · batch PRDT- 1007WINGSBIOTECH LLP (173205) · Failed: The sample does not conforms to claim as per IP 2018 and Addendum 2021 in respect to the Assay of Prednisolone · RDTL Chandigarh
47. Himachal PradeshMoxtas Distab 250 Tablets, Amoxycillin trihydrate dispersible tablets IP. · batch MALT-2019Wings Novitas Healthcare LLP (173205) · Failed: 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. · State Lab Drugs Control Laboratory, Telangana.
48. Himachal PradeshDexamethasone Sodium Phosphate Injection I.P. (8mg/2ml) · batch 323-885ZEE LABORATORIES LTD (173025) · Failed: 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". · CDL Kolkata
49. Himachal PradeshGentamicin Sulphate Injection I.P. 2ml · batch 323-216ZEE LABORATORIES LTD (173025) · Failed: 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" · CDL Kolkata
50. Himachal PradeshCeftriaxone Injection I.P · batch 324-166Zee Laboratories Limited (173205) · Failed: 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). · CDL Kolkata
51. State not givenTolcenta-P Tablets, · batch ZT22806Zenomed Health Care Pvt.Ltd · Failed: NOT OF STANDARD QUALITY · State Lab Drugs Control