September 2024.71 failed batches.

Batches, by manufacturer

1. Himachal PradeshCefoperazone and Sulbactam for Injection (KEFZONE-S INJECTION) · batch AB234007CANG Lifesciences India Ltd (174101) · Failed: Particulate Matter · RDTL Chandigarh
2. Himachal PradeshPiperacillin and Tazobactam Injection IP (CASIDTAZ P Injection) · batch AB154006BANG Lifesciences India Ltd (174101) · Failed: Particulate Matter · RDTL Chandigarh
3. GujaratAluminum Hydroxide, Simethicone & Magnesium Hydroxide Suspension (Spisam Gel) · batch L22455Aan Pharma Pvt. Ltd (380060) · Failed: Assay / Content of Magnesium Hydroxide, Simethicone and Aluminium Hydroxide gel · CDTL Mumbai
4. UttarakhandCefuroxime Axetil Tablets IP 500 mg (JKMSCL Supply) · batch JAK-23Agron Remedies Pvt Ltd (244713) · Failed: The sample fails in the Description, Dissolution and Assay of Cefuroxime Axetil w.r.t the sample portion received as above · CFDL Jammu (J&K)
5. SikkimPantoprazole Gastro-resistant Tablets IP.. (PAN 40) · batch 22442076Alkem Health Science, A Unit Of Alkem Laboratories Limited (737137) · Failed: Assay and Dissolution in acid stage · RDTL Guwahati
6. SikkimAmoxicillin And Potassium Clavulanate Tablets I.P. (CLAVAM 625) · batch 23443940Alkem Health Science, A Unit of Alkem Laboratories Limited (737137) · Failed: Identification, Dissolution and Assay of Amoxicillin and Clavulanic Acid · RDTL Guwahati
7. Himachal PradeshCefpodoxime Tablets IP 200 mg (Monocef-O 200) · batch BPH232520Aristo Pharmaceuticals Pvt. Ltd (173205) · Failed: Identification and Assay/ Content of Cefpodoxime · RDTL Guwahati
8. Himachal PradeshCefpodoxime Tablets IP 200 mg (Monocef-O 200) · batch BPD231045Aristo Pharmaceuticals Pvt. Ltd (173205) · Failed: Identification and Assay/ Content of Cefpodoxime · RDTL Guwahati
9. State not givenCetirizine Dihydrochloride Syrup (Citrize- P) · batch 275Arrow Pharma (453111) · Failed: pH · CDTL Hyderabad
10. State not givenLoperamide Hydrochloride Tablets I.P. 2 mg (LOMJAN) · batch L-2401Arya Pharmaceuticals · Failed: Dissolution and Assay/ Content of Loperamide Hydrochloride and Description · RDTL Guwahati
11. State not givenCiprofloxacin Tablets IP 500 mg (CIPRODAC 500) · batch JKBD24009Cadila Pharmaceuticals Limited (184121) · Failed: Dissolution of Ciprofloxacin · RDTL Guwahati
12. Himachal PradeshNeurotem-NT · batch CPT-2698Catasta Pharmaceuticals (173205) · Failed: The given Drug Sample does not comply to the contents of Assay with respect to Pregabalin ( 23.26% of claim) · Drug Testing Laboratory Srinagar (J&K) vide report on Form 13 bearing No. L/DA/2024- 25/1191 Dated: 05.09.2024. (Report attached as Annexure A)
13. Himachal PradeshCipronir 500 (Ciprofloxacin Tablets IP 500 mg) · batch CCF212003Celebrity Biopharma Ltd (174103) · Failed: Dissolution · CDL Kolkata
14. TelanganaGlycopyrrolate 0.5 mg / 5ml + Neostigmine methysulfate Injection 2.5 mg / 5ml) (Stimin) · batch GNI2406ACCelon Laboratories Pvt. Ltd (500090) · Failed: Description & Clarity of Solution · CDL Kolkata
15. UttarakhandC Mont LC Kid 60 ml (Montelukast & Leveocetirizine Dihydrochloride syrup) · batch AL 23206Cian Healthcare Ltd (247661) · Failed: The content of montelukast is not within the limits of Schedule ?V? of Drugs & Cosmetics Act & Rules · DTL Thiruvananthapuram
16. State not givenFluorometholone Eye Drops IP · batch CHE-3044Cotec Healthcare pvt.Ltd (247667) · Failed: It fails the test ?Uniformity of Volume? and ?Assay? as per IP · DTL Thiruvananthapuram
17. State not givenFluconazole Tablets IP 150 mg (Flucse - 150) · batch CHT23621Cureza Healthcare Pvt. Ltd (474001) · Failed: Uniformity of weight · CDTL Mumbai
18. UttarakhandDried Aluminium Hydroxide, Magnesium Hydroxide & Activated Dimethicone Suspension (Chill Acid MPS) · batch DNS- 2210001Devout Nord (I) Ltd (249403) · Failed: Description, Microbial Limit Test, Identification and Assay of Activated Dimethicone · CDL Kolkata
19. Himachal PradeshBupropion Hydrochloride Extended Release Tablets USP (Nopion 150 Tablets) · batch GTD0768Digital Vision · Failed: Description and Assay of Bupropion Hydrochloride · RDTL Chandigarh
20. State not givenPanlib 40 Tablets · batch HTN 102AHimalaya Meditek pvt.Ltd · Failed: It fails the test Dissolution? and ?Assay? as per IP · DTL Thiruvananthapuram
21. State not givenWintel 40 Tablets · batch HTN257DHimalaya Meditek pvt.Ltd (248197) · Failed: It fails the test ?Dissolution? as per IP · DTL Thiruvananthapuram
22. HaryanaDiclofenac Sodium Tablets IP 50 mg · batch HDFA02Hindustan Antibiotics Ltd (121001) · Failed: Dissolution · CDL Kolkata
23. HaryanaMetronidazole Tablets I.P. 400 mg · batch HMAA04Hindustan Antibiotics Ltd (121001) · Failed: Dissolution · CDL Kolkata
24. GujaratMoxica -250 [Amoxicillin Dispersible Tablets IP 250 mg] · batch SD 243Indica Pharmaceuticals (P) Ltd (382345) · Failed: It fails the test ?Disintegration? and ?Uniformity of Dispersion? specified in the Laboratory Protocol as per IP · DTL Thiruvananthapuram
25. Himachal PradeshNimesulide & Paracetamol Tablets (Nimuvent-P Tablets) · batch GD332005Innova Captab Limited · Failed: Description · CDL Kolkata
26. SikkimAceclofenac 100 mg, Serratiopeptidas e 15 mg & Paracetamol 325 mg Tablets(ZEROD OL-SP TABLETS) · batch FND033076 ASIpca Laboratories Ltd (737121) · Failed: Identification and Assay of Aceclofenac Serratiopeptidas e and Paracetamol · RDTL Chandigarh
27. Himachal PradeshTorsemide Tablets IP 10 mg (Torverge- 10 Tablets) · batch GT7137AJ.M.LABORATORIES (173211) · Failed: Assay of Torsemide · RDTL Chandigarh
28. UttarakhandBISACODYL TABLETS I.P. (Bisalax Tablets) · batch T-14996Karnani Pharmaceutical Pvt. Ltd (248011) · Failed: Dissolution (Buffer stage), Related substances and Assay of Bisacodyl · CDTL Mumbai
29. State not givenLoperamide Hydrochloride Tablets IP (JKMSCL Hospital Supply) · batch T-16201Karnani Pharmaceuticals Pvt. Ltd (248011) · Failed: The sample does not conform to IP with respect to the test for Dissolution & Assay · Drug Testing Laboratory Srinagar (J&K) vide report on Form 13 bearing No. L/DA/2024-25/1311 Dated: 27.09.2024. (Report attached as Annexure C)
30. KeralaCough Syrup · batch D 1278/24- 25Kerala Medical Services Corporation · Failed: The sample fails the ?Descriptive part? for oral dosage forms of Schedule V of drugs and cosmetics Act and Rules, as the syrup contains red coloured suspended paticles · DTL Thiruvananthapuram
31. KeralaGlimepiride Tab IP · batch D1272/24-25Kerala Medical Services Corporation · Failed: The sample fails the descriptive part for tablets as they are not sufficiently hard to withstand handling without crumbling or breaking and further tests cannot be performed due to above reason · DTL Thiruvananthapuram
32. KeralaPantoprazole Inj.BP 40 mg · batch D 0923/24- 25Kerala Medical Services Corporation · Failed: It fails the test ?Sterility? specified in the laboratory protocol as per IP · DTL Thiruvananthapuram
33. KeralaTelmisartan Tab IP 40 mg · batch D1153/24-25Kerala Medical Services Corporation · Failed: The sample does not conform to IP Standards with respective to ?Descriptive part? of tablets and further tests cannot be performed due to above reasons. · DTL Thiruvananthapuram
34. Himachal PradeshIfosfamide for Injection IP with Mesna Injection (Celofos 1000 Injection) · batch OL0492(for Ifosfamide), GN2064(for Mesna)Kwality Pharmaceuticals Limited (176201) · Failed: Water and Assay of Ifosfamide · RDTL Chandigarh
35. UttarakhandCalcium 500 mg and Vitamin D3 250 IU Tablets IP · batch LMT240025Life Max Cancer Laboratories (249403) · Failed: Assay of Calcium and Vitamin D3 and Dissolution of Calcium · RDTL Guwahati
36. UttarakhandGlimepiride Tablets I.P. 2 mg · batch LMT240157Life Max Cancer Laboratories (249403) · Failed: Dissolution · RDTL Guwahati
37. UttarakhandGlimepiride Tablets IP 1 mg · batch LMT240339Life Max Cancer Laboratories (249403) · Failed: Dissolution · RDTL Guwahati
38. Himachal PradeshCalcium Gluconate Injection I.P. 10 ml · batch MA24E55Martin & Brown Biosciences Pvt. Ltd (173205) · Failed: Description & Particulate matter · CDL Kolkata
39. HaryanaCloxacillin Sodium Capsules IP 250 mg · batch CLCA-04Nestor Pharmaceuticals Ltd (121001) · Failed: The sample does not conform to IP Standards with respect to ?Descriptive part? of hard gelatin capsules and further tests cannot be performed due to reasons secified in the laboratory protocol · DTL Thiruvananthapuram
40. HaryanaFrusemide Injection IP 20 mg · batch FRIB-03Nestor Pharmaceuticals Ltd (121001) · Failed: It fails the test ?Sterility? as per IP · DTL Thiruvananthapuram
41. Himachal PradeshPromethazine Hydrochloride Injection I.P. (PHENERGAN) · batch AHH0367Nitin Lifesciences Ltd (173025) · Failed: Assay of Promethazine Hydrochloride · RDTL Guwahati
42. GujaratKetoconazole Cream BP (Nozal Cream) · batch 4129Olcare Laboratories (363035) · Failed: Assay · CDL Kolkata
43. HaryanaFexofenadine Hydrochloride Tablets IP · batch T-2403971Oscar Remedies Pvt. Ltd (135001) · Failed: Uniformity of Weight and Dissolution · RDTL Guwahati
44. KeralaYogaraja Guggulu Tablet · batch P 592324Oushadhi, The Pharmaceutical corporation · Failed: The sample does not conform to API Standards. It fails the tests ?Total Ash? as per API Standards. · DTL Thiruvananthapuram
45. West BengalCOMPOUND SODIUM LACTATE INJECTION I.P. (RL) · batch 03BF2475Paschim Banga Pharmaceuticals (733214) · Failed: Bacterial Endotoxins Test · RDTL Guwahati
46. Himachal PradeshGentamicin Sulphate Injection IP (P- Genta Injection) · batch PA022415Primus Pharmaceuticals (173030) · Failed: pH · CDTL Mumbai
47. Himachal PradeshHeparin Sodium Injection IP 5000 IU / 5ml (Hepathin 5000 Injection 5 ml / vial) · batch L1192317GProtech Telelinks (173030) · Failed: Description & Particulate matter · CDL Kolkata
48. Himachal PradeshHeparin Sodium Injection IP 5000 IU / 5ml (Hepathin 5000 Injection 5 ml / vial) · batch L1192317CProtech Telelinks (173030) · Failed: Description, Particulate matter and Assay of Heparin (Anti- factor IIa activity) · CDL Kolkata
49. Himachal PradeshOxytocin Injection I.P. 5 IU/1 ml · batch OTC-382APushkar Pharma (173030) · Failed: Description, Particulate matter & Assay of Oxytocin · CDL Kolkata
50. GujaratOxytocin Injection I.P. 1 ml · batch 22X23002Radiant Parenterals Ltd (391760) · Failed: Assay · CDL Kolkata
51. MaharashtraDomperidon Suspension (Vomitel) · batch U587F2401Rainbow Life Sciences Pvt. Ltd (441501) · Failed: Assay · CDL Kolkata
52. State not givenOfloxacin and Ornidazole Intra Uterine Solution (Vet.) (UTROCLEAR- OZ SOLUTION) · batch V-2727Ramson Remedies · Failed: Assay of Ofloxacin and Ornidazole · RDTL Chandigarh
53. HaryanaGentamicin Injection I.P. (Gentagain ) · batch IGMJ330Regain Laboratories (125001) · Failed: Description & Particulate matter · CDL Kolkata
54. DelhiRamipril Tablets I.P. 2.5 mg · batch RT-231084Relief Biotech Pvt. Ltd (247656) · Failed: Assay of Ramipril · RDTL Guwahati
55. UttarakhandOmeprazole & Domperidone Capsules IP (Omerin-D Capsules) · batch RC-331223Renowed Life Sciences (249403) · Failed: Dissolution of Omeprazole · CDL Kolkata
56. UttarakhandOfloxacin & Ornidazole Tablets I.P. (SMB OZ TABLETS) · batch B22-114Saint Michael Biotech (247656) · Failed: Dissolution of Ofloxacin & Ornidazole · RDTL Guwahati
57. State not givenFexofenadine Hydrochloride Tablets I.P. · batch 658-021Signature Phytochemical Industries (248011) · Failed: Dissolution · RDTL Guwahati
58. Himachal PradeshDextromethorph an Hydrobromide, Chlorpheniramin e Maleate and Phenylephrine Hydrochloride Syrup (COUGH- DM Cough Syrup) · batch SHL3037Sunfine Healthcare (173205) · Failed: Assay of Phenylphrine Hydrochloride · RDTL Chandigarh
59. UttarakhandFloxages-OZ (Ofloxacin and Ornidazole Tablets IP) · batch SPY41223Suraksha Pharma pvt.Ltd (247667) · Failed: It fails the test ?Dissolution? as per IP · DTL Thiruvananthapuram
60. HaryanaMetformin Hydrochloride 500 mg SR & Glimepiride 2 mg Tablets IP (SPAMET GM 2 Tablets) · batch TF147ASwiss Biotech Parenterals (132001) · Failed: Dissolution of Glimepiride · CDL Kolkata
61. Himachal PradeshMethylcobalami n Injection 2500 mcg (NUROFENS- 2500 Injection) · batch SRID24010 1Systole Remedies Pvt. Ltd (173030) · Failed: Particulate matter and Assay of Methylcobalami n · RDTL Chandigarh
62. Himachal PradeshTrypsin, Bromelain & Rutoside Trihydrate Tablets [Flavoshine] · batch TTF24065Tiruvision Medcare (173205) · Failed: The sample fails the test ?Disintegration? specified in the Laboratory protocol as per IP · DTL Thiruvananthapuram
63. State not givenCalcium and Vitamin D3 Tablets I.P (SHELCAL 500) · batch GDXD0581Under Investigation · Failed: Identification, Dissolution, Assay and Description. · Not applicable
64. State not givenNandrolone Decanoate Injection IP 25mg/ml (Deca- Durabolin 25 Inj.) · batch G202620Under Investigation · Failed: Identification · Not applicable
65. State not givenPantoprazole Gastro-Resistant and Domperidone Prolonged- Release Capsules I.P. (PAN-D) · batch 23443507Under Investigation · Failed: Assay of both Pantoprazole and Domeperidone · Not applicable
66. State not givenTamsulosin and Dutasteride Tablets (Urimax- D) · batch GH30334Under Investigation · Failed: Description, Identification and Assay · Not applicable
67. Himachal PradeshB - Cidal 625 · batch UT232859VADSP Pharmaceuticals (174103) · Failed: The content of Clavulanic acid is not with in the limit of ?Schedule V? of Drugs and Cosmetics Act & Rules thereunder · DTL Thiruvananthapuram
68. UttarakhandParacetamol Paediatric Oral Suspension IP · batch V0244001Vivimed Labs Limited (244713) · Failed: Related Substances · CDTL Mumbai
69. Himachal PradeshCeftriiaxone Injection I.P. 1g · batch 324476Zee Laboratories Ltd (173025) · Failed: Particulate Matter & Clarity of Solution · CDL Kolkata
70. Himachal PradeshGentamycin Sulphate Injection I.P. 40 mg/ml · batch 324-564Zee Laboratories Ltd (173025) · Failed: Description & Particulate matter · CDL Kolkata
71. Himachal PradeshGlipizide Tablets I.P. 5 mg · batch Z24-187Zee Laboratories Ltd (173205) · Failed: Dissolution · CDL Kolkata