August 2024.64 failed batches.

Batches, by manufacturer

1. State not givenPANCEF-OF · batch T442401Aglomed Ltd (247661) · Failed: The sample does not comply with respect to the test parameters at S.No II d (Disintegratio n Test) · Drug Testing Laboratory Srinagar (J&K) vide report on Form 13 bearing No. L/DA/2024-25/978 Dated: 07.08.2024
2. Himachal PradeshMoxymed CV · batch ABT 23316Alexa Pharmaceuticals (173205) · Failed: The content of Amoxycillin and Clavulanic acid is not with in the limits of schedule ?V? of Drugs and Cosmetics Act & Rules as mentioned in the Laboratory protocol · DTL Thiruvananthapuram
3. SikkimAmoxicillin And Potassium Clavulanate Tablets IP (Clavam 625) · batch 23443940Alkem Health Science (737137) · Failed: Spurious Identification & Assay of Amoxycillin Trihydrate & Potassium Clavulanate · CDL Kolkata
4. SikkimPantoprazole Gastro-Resistant and Domperidone Prolonged-Release Capsules IP (Pan - D) · batch 23444296Alkem Health Science (737137) · Failed: Spurious Identification, Assay, Dissolution & Related Substancces · CDL Kolkata
5. Himachal PradeshAdrenaline Injection I.P. Sterile 1 ml · batch AI22268Alves Healthcare Pvt. Ltd (174101) · Failed: Description, Appearance of Solution, Particulate Matter & Assay · CDL Kolkata
6. GujaratSalbutamol, Bromhexine HCI, Guaifenesin and Menthol Syrup(Acozil Expectorant) · batch A-244003Antila Lifesciences Pvt Ltd (391775) · Failed: Not of Standard Quality · CDTL Mumbai
7. GujaratVitamin B Complex with Vitamin C Softgels · batch 1423Asoj Soft Caps Pvt. Ltd (391510) · Failed: Assay of Calcium Pantothenate · CDL Kolkata
8. Himachal PradeshLaxnorm Solution (Lactulose Solution USP) · batch LG24-0204Athens Life Sciences (173030) · Failed: Assay · CDL Kolkata
9. State not givenKudajarishtam · batch 110Bala Herbals · Failed: It fails the tests ?Total Solids? and ?Specific gravity? as per API. · DTL Thiruvananthapuram
10. KeralaHaridrakhanda m · batch 207/23Bhaskara Vilasam Vaidyasala (695561) · Failed: It fails the test ?pH? as per API. · DTL Thiruvananthapuram
11. KeralaYogaraja Guggulu · batch 209/21Bhaskara Vilasam Vaidyasala (695561) · Failed: It fails the test Alcohol Soluble Extractive and pH as per API · DTL Thiruvananthapuram
12. State not givenRolled Gauze (Non- Sterilized) · batch RG-006Blazon India · Failed: Width, Absorbency, Scouring Loss, Freedom from Optical Whitener, Mass, Length · CDL Kolkata
13. PunjabCefepime & Tazobactam for Injection (Crupime - TZ Kid Injection) · batch I230041ACosmas Research Lab. Ltd (141008) · Failed: Particulate Matter · CDL Kolkata
14. Himachal PradeshCefoperazone & Sulbactam For Injection (Todaycef 1.5 G) · batch D0481Daxin Pharmaceuticals Pvt. Ltd (174103) · Failed: Clarity of Solution, Particulate matter and Assay · CDL Kolkata
15. Himachal PradeshPantomed -40 · batch GTEO230 CDigital Vision (173030) · Failed: It fails the test ?Dissolution? as per IP · DTL Thiruvananthapuram
16. GujaratAlprazolam Tablets IP 0.25 mg (Erazol- 0.25 Tablets) · batch 16747ELIKEM Pharmaceuticals Private Limited (382721) · Failed: Dissolution · RDTL Guwahati
17. Himachal PradeshTelma H (Telmisartan 40 mg and Hydrochlorot hiazide 12.5mg Tablets IP) · batch 18230080Glenmark Pharmaceuticals Ltd · Failed: Dissolution & Assay of Telmisartan · Not applicable
18. Himachal PradeshPaziva -40 · batch GT300234Gnosis Pharmaceuticals Pvt.Ltd (173030) · Failed: It fails the test ?Dissolution? as per IP · DTL Thiruvananthapuram
19. HaryanaMetronidazole Tablets IP 400mg · batch HMAA04HINDUSTAN ANTIBIOTICS LTD (121001) · Failed: Dissolution · RDTL Guwahati
20. UttarakhandNimesulide, Paracetamol and Chlorzoxazone Tablets (NICIP MR) · batch GS22236HSN International (249403) · Failed: Disintegration · CDL Kolkata
21. Himachal PradeshHeparin Sodium Injection 5000 Units (Hostranil Injection) · batch HIHE23028AHealth Biotech Ltd (173205) · Failed: Particulate Matter, Bacterial Endotoxins & Sterility · CDL Kolkata
22. Himachal PradeshCepodem XP 50 Dry Suspension (Cefpodoxime Proxetil and Potassium Clavulanate Oral Suspension) · batch PEA0083Hetero Labs Limited (173205) · Failed: pH and Assay of Potassium Clavulanate · CDL Kolkata
23. KarnatakaParacetamol Tablets IP 500 mg · batch 2508323Karnataka Antibiotics and Pharmaceuticals Ltd (560058) · Failed: Description · CDL Kolkata
24. KeralaPantoprazole Inj. BP 40 mg · batch D0726/24- 25Kerala Medical Services Corporation · Failed: The sample does not comply with BP. It fails the test Particulate contaminatio n clarity and colour of solution. · DTL Thiruvananthapuram
25. Himachal PradeshRifmin 550 (Rifaximin Tablets 550 mg) · batch TX-17798Legen Healthcare (173220) · Failed: Dissolution & Water · CDL Kolkata
26. UttarakhandCalcium 500 mg with Vitamin D3 250 IU Tablets IP · batch LMT231058Life Max Cancer Laboratories (249403) · Failed: Assay of Calcium and vitamin D3 and Dissolution of Calcium · RDTL Guwahati
27. UttarakhandOlmesartan Medoxomil Tablets IP 40 mg · batch LMT240387Life Max Cancer Laboratories (249403) · Failed: Dissolution of Olmesartan Medoxomil · RDTL Guwahati
28. UttarakhandTelmisartan Tablets IP 40 mg · batch LMT240528Life Max Cancer Laboratories (249403) · Failed: Description · RDTL Guwahati
29. UttarakhandTelmisartan Tablets IP 40 mg · batch LMT240502Life Max Cancer Laboratories (249403) · Failed: Description · RDTL Guwahati
30. UttarakhandTelmisartan Tablets IP 40 mg · batch LMT240502Life Max Cancer Laboratories (249403) · Failed: Description · RDTL Guwahati
31. Himachal PradeshEscitalopram and Clonazepam Tablets IP (Klozaps-ES Tablets) · batch NTD0203M/.s Digital Vision (173030) · Failed: Assay of Escitalopram Oxalate calculated as Escitalopram and Clonazepam · RDTL Chandigarh
32. Himachal PradeshPhenytoin Sodium Injection USP · batch HIPY23012CM/.s Health Biotech Ltd (173205) · Failed: Alcohol, Propylene Glycol and Particulate Matter · RDTL Chandigarh
33. GujaratINFUSION SET-NV · batch KT-015MEDIVISION HEALTHCARE (382445) · Failed: Sterility · RDTL Guwahati
34. DamanDeflazacort Tablets ( Defcort 6 Tablets) · batch GDB23041AMacleods Pharmaceuticals Ltd (396210) · Failed: Test of Identification and Assay of Deflazacort · Not applicable
35. UttarakhandAmoxycillin and Potassium Clavulanate Tablets IP 625 mg (Renamega- CV 625) · batch MD19AA08Malik Lifesciences Pvt. Ltd (247667) · Failed: Assay and Uniformity of content of Clavulanic Acid and Dissolution of Amoxycillin and Clavulanic Acid · RDTL Guwahati
36. State not givenGLIMEPIRIDE TABLETS IP (2 mg) · batch MT234799Mascot Health Series Pvt. Ltd (249403) · Failed: Description · RDTL Guwahati
37. Himachal PradeshFexofenadine Hydrochloride Tablets IP 120 mg · batch MP9AA2303Maxtar Bio-Genics (173205) · Failed: Dissolution · CDL Kolkata
38. Himachal PradeshFexofenadine Hydrochloride Tablets IP 120 mg · batch MP9AA2303 (Two different samples received with same batch number)Maxtar Bio-Genics (173205) · Failed: Dissolution · CDL Kolkata
39. Himachal PradeshAmoxycillin & Potassium Clavulanate Tablets (Mexclav 625) · batch 7372Meg Lifesciences (173001) · Failed: Spurious Identification & Assay of Amoxycillin Trihydrate & Potassium Clavulanate · CDL Kolkata
40. State not givenAtropine Sulphate Injection IP 2 ml · batch ATA12407Nandani Medical Laboratories Pvt. Ltd · Failed: Description & Particulate Matter · CDL Kolkata
41. HaryanaCefixime Oral Suspension IP (Dry Syrup) · batch CADA-02Nestor Pharmaceuticals Ltd (121001) · Failed: It fails the test ?Assay? and ?water? as per IP · DTL Thiruvananthapuram
42. HaryanaFrusemide Injection IP 20 mg · batch FRIB-03Nestor Pharmaceuticals Ltd (121001) · Failed: It fails the test ?Sterility? as per IP · DTL Thiruvananthapuram
43. State not givenCiprofloxacin Tablets I.P. 500 mg (Ocif-500) · batch OCF5-23- 221Ornate Labs Pvt. Ltd (842005) · Failed: Dissolution & Assay · CDL Kolkata
44. GujaratBuflam Forte Suspension (Ibuprofen & Paracetamol Oral Suspension) · batch 231202AOrnate Pharma Pvt. Ltd (382410) · Failed: Uniformity of Volume · CDL Kolkata
45. Uttar PradeshAtropine Sulphate Injection I.P. (Atropine Sulphate) · batch AS-9057 (Two different samples received with same batch number)Priya Pharmaceuticals (208012) · Failed: Description, Particulate Matter, Extractable Volume, Assay · CDL Kolkata
46. Uttar PradeshAtropine Sulphate Injection I.P. (Atropine Sulphate) · batch AS-9057 (Two different samples received with same batch number)Priya Pharmaceuticals (208012) · Failed: Description, Particulate Matter, Extractable Volume, Assay · CDL Kolkata
47. Uttar PradeshAtropine Sulphate Injection I.P. (Atropine Sulphate) · batch AS-9055 (Two different samples received with same batch number)Priya Pharmaceuticals (208012) · Failed: Description, pH, Particulate Matter, Extractable Volume · CDL Kolkata
48. Uttar PradeshAtropine Sulphate Injection I.P. (Atropine Sulphate) · batch AS-9055 (Two different samples received with same batch number)Priya Pharmaceuticals (208012) · Failed: Description, pH, Particulate Matter, Extractable Volume · CDL Kolkata
49. UttarakhandCalcium And Vitamin D3 Tablets IP Shelcal 500 (Shelcal) · batch GDXD0581Pure & Cure Healthcare Pvt. Ltd (249403) · Failed: Description, Identification of Vitamin D3, Dissolution of Calcium and Assay of Calcium & Vitamin D3 · CDL Kolkata
50. State not givenMontair LC Kid (Montelukast Sodium & Levocetirizne Hydrochloride Dispersible Tablets) · batch AFB23W73Pure & Cure Healthcare Pvt. Ltd (249403) · Failed: Uniformity of Dispersion & Assay of Montelukast Sodium · CDL Kolkata
51. Uttar PradeshDiclofenac Sodium IP · batch DFS- 2405031Sara Exports Ltd (201009) · Failed: Not of Standard Quality · CDTL Mumbai
52. Himachal PradeshHeparin Sodium Injection IP 25000 IU / 5ml · batch GV3C002Scott-Edil Pharmacia Ltd (173205) · Failed: Description & Particulate Matter · CDL Kolkata
53. Himachal PradeshMetformin Hydrochloride Sustained-release Tablets IP (Glycimet-SR-500) · batch GT3J023Scott-Edil Pharmacia Ltd (173205) · Failed: Dissolution of Metformin Hydrochloride · CDL Kolkata
54. State not givenTab Nodosis · batch SMST- 24151Steadfast Medishield pvt.Ltd · Failed: It fails the test ?Assay? as per IP · DTL Thiruvananthapuram
55. AssamUrsocol 300 (Ursodeoxych olic Acid Tablets IP) · batch GTE1350ASun Pharma Laboratories Ltd (781128) · Failed: Assay of ursodeoxycholi c Acid, Description · Not applicable
56. GujaratPulmosil (Sildenafil Injection) · batch KFA0300Sun Pharmaceuticals Ind., Ltd (389350) · Failed: Test for Description, Volume in container, Particulate matter, sterility and Assay of Sildenafil Citrate equivalent to Sildenafil. · NRS Medical College 138 AJC Bose Road, Kolkata 700014
57. SikkimPantocid (Pantoprazole Tablets IP) · batch SID2041ASunpharma laboratories ltd (737135) · Failed: Identification and Assay · Not applicable
58. Himachal PradeshTelmisartan Tablets IP 40 mg · batch 251TTF011Swiss Garnier Life Science (174315) · Failed: Dissolution · RDTL Guwahati
59. Uttar PradeshCalcium and Vitamin D3 Tablets I.P. · batch UDT11151Unicure India Ltd (201301) · Failed: Assay of vitamin D3 · RDTL Guwahati
60. Himachal PradeshNimesulide, Phenylephrine Hydrochloride & Levocetirizine Dihydrochloride Tablets (Nunim- Cold) · batch T-23115Unispeed Pharmaceuticals Pvt. Ltd (173205) · Failed: Description · CDL Kolkata
61. Himachal PradeshVingel XL Pro Gel (Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate and Menthol Gel) · batch F23208Universal Twin Labs · Failed: Assay of Diclofenac Diethylamine & Methyl Salicylate · CDL Kolkata
62. Uttar PradeshCompound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection) (RL 500 ml) · batch MP24050511 1Vision Parenteral Pvt. Ltd (273209) · Failed: Assay of Calcium Chloride · CDL Kolkata
63. Uttar PradeshCompound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection) RL 500ml · batch MP24040508 5Vision Parentral Pvt. Ltd (273209) · Failed: Sterility · CDL Kolkata
64. Himachal PradeshParacetamol, Phenylephrine Hydrochloride and Cetirizine Hydrochloride Suspension (Cethel Cold DS Suspension) · batch WPS-013Win Cure Pharma (173205) · Failed: Assay of Paracetamol, Phenylephrine Hydrochloride and Cetirizine Hydrochloride · RDTL Chandigarh