June 2024.61 failed batches.

Batches, by manufacturer

1. State not givenINFI-650 TABLETS (PARACETAMOL TABLETS I.P. 650 mg) · batch AT-100008ABARIS HEALTHCARE · Failed: THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR DISSOLUTION TEST. · State Lab Maharashtra
2. State not givenDRPLAN-DSR (Pantoprazole Gasto-resistant & Domperidone Prolonged-release Capsules IP) · batch AC2209003AADDII BIOTECH PVT. LTD · Failed: THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR PANTOPRAZOLE AND DOMPERIDONE CAPSULES FOR THE DISSOLUTION TEST (PANTOPRAZOLE) . · State Lab Maharashtra
3. State not givenCOZOL- D(Omeprazole with Domperidone Capsules) · batch AC1952ALICON PHARMACEUTICAL PVT LTD · Failed: THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR OMEPRAZOLE AND DOMPERIDONE CAPSULES FOR THE DISSOLUTION TEST (OMEPRAZOLE). THE SAMPLE IS OFFICIAL IN IP. · State Lab Maharashtra
4. State not givenRABEPP TABLETS (Rabeprazole Sodium Tablets IP) · batch ATG2K135ANROSE PHARMA · Failed: CONTENT OF RABEPRAZOLE SODIUM IM THE SAMPLE IS LESS (65.04% OF THE LABELLED AMOUNT) THAN THE IP LIMIT WITH RESPECT TO ABOVE PROTOCOL. (IP LIMIT 90.0% - 110.0%) · State Lab Maharashtra
5. UttarakhandPantoprazole Gastro- Resistant Tablets IP 40 mg. · batch PGR-07Agron Remedies Pvt. Ltd (244713) · Failed: Dissolution · RDTL Guwahati
6. State not givenVolKast Kid Syrup 60 ml. · batch ABS- 2301022Amentis Biotech Pvt. Ltd · Failed: CONTENT OF MONTELUKAST AND LEVOCETIRIZINE GYDROCHLORIDE IN THE SAMPLE IS LESS (i.e. MONTELUKAST IS 10.50% AND LEVOCETIRIZINE HYDROCHLORIDE IS 71.88% OF THE STATED AMOUNT) THAN THE PERMISSIBLE LIMITS. · State Lab Maharashtra
7. UttarakhandEtoricoxib Tablets I.P. 90 mg. · batch ECX-2304Apple Formulations Private Limited (247667) · Failed: Dissolution · RDTL Guwahati
8. State not givenLevetiracetam Tablets U.S.P.500 Mg (LEVEEG-500) · batch T23D050ABAJAJ FORMULATIONS · Failed: THE SAMPLE DOES NOT COMPLY WITH USP REQUIREMENTS FOR DISSOLUTION. · State Lab Maharashtra
9. State not givenLevocetrizine Dihydrochloride & Montelukast Sodium Tablets I.P. Zeemont · batch T22H370CBajaj Formulations · Failed: THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR DISSOLUTION TEST FOR MONTELUKAST. · State Lab Maharashtra
10. MaharashtraPropylene Glycol USP/IP · batch BT1205B0 4072023Balaji Amines Limited (413255) · Failed: Relative Density · CDL Kolkata
11. KeralaHaridrakhandam · batch 207/23Bhaskaravilasam Vaidyasala (695561) · Failed: It fails the test ?pH? as per API · DTL Thiruvananthapuram
12. KeralaYogarajaguggulu · batch 209/21Bhaskaravilasam Vaidyasala (695561) · Failed: It fails the test ?Alcohol soluble Extractive and pH? as per API · DTL Thiruvananthapuram
13. GujaratExtuss-D (Dextromethorp han HBR, Chlorpheniramin e Maleate & Phenylephrine HCL Syrup) · batch 2402168Brij Healthcare Pvt. Ltd (383001) · Failed: Assay of Phenylephrin e Hydrochloride · CDTL Mumbai
14. Himachal PradeshFexofenadine Hydrochloride Tablets IP (MANOFEX-180 TABLETS) · batch CT232407 15ACMG BIOTECH PVT. LTD (176501) · Failed: Dissolution (In 10 minutes) and (in 30 minutes) · RDTL Chandigarh
15. State not givenM2 Pan-DSR (Pantoprazole Gastro-resistant & Domperidone Prolonged-release Capsules IP) · batch CWHC-283COSWAY PHARMACEUTICALS · Failed: THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR DISSOLUTION OF PANTOPRAZOLE AT ACID STAGE · State Lab Maharashtra
16. Himachal PradeshCeftriaxone for Injection I.P. 1 gm · batch DC30119Captab Biotec · Failed: Particulate matter · CDL Kolkata
17. State not givenPantakos-40 (Pantoprazole Gastro-resistant Tablets IP ) · batch CCT231092 BCent Cure Pvt Ltd · Failed: THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR DISSOLUTION IN BUFFER STAGE. · State Lab Maharashtra
18. Himachal PradeshCefixime & Ofloxacin Tablets (CEFIKAM OF 200) · batch DB230057Daxin Pharmaceuticals Pvt. Ltd (174103) · Failed: Assay of Cefixime Trihydrate & Assay Ofloxacin · CDL Kolkata
19. State not givenELTHROM-200 (Azithromycin oral suspension IP) 15ML · batch G-042/5045ELFIN DRUGS PVT. LTD · Failed: CONTENT OF AZITHROMYCIN IN THE SAMPLE IS LESS (72.96% OF LABELLED AMOUNT) THAN THE IP LIMIT WITH RESPECT TO ABOVE PROTOCOL. (IP LIMIT-90.0%- 110.0%) · State Lab Maharashtra
20. State not givenAlpracan 0.5 Tablets (Alprazolam Tablets) · batch T2455Evolet Pharmaceutical Pvt. Ltd · Failed: THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR ALPRAZOLAM TABLETS FOR THE DISSOLUTION TEST WITH RESPECT TO ABOVE PROTOCOL. · State Lab Maharashtra
21. GujaratExo Cheri (Dextromethorp han Hydrobromide Chlorpheniramin e Maleate Pheylephrine Hydrochloride Cough Syrup) · batch L/040618Exotic Pharma (389001) · Failed: pH · CDTL Mumbai
22. UttarakhandRanitidine Hydrochloride Tablets (Ranylaj-150) · batch GTDE3019Francis Remdies (India) Pvt.Ltd (247670) · Failed: Description · CDL Kolkata
23. State not givenCANDITRAL 100 (ITRACONAZOLE CAPSULE B.P. 100 MG) · batch 5230123GLENMARK PHARMACEUTICALS LTD · Failed: THE SAMPLE DOES NOT COMPLY WITH B P REQUIREMENTS FOR DISSOLUTION TEST · State Lab Maharashtra
24. Himachal PradeshIron and Folic Acid Syrup IP · batch IFIS23015Galpha Laboratories Limited (173205) · Failed: Assay of Folic Acid · RDTL Guwahati
25. State not givenEsomeprazole Gastro- Resistant Tablets IP 40 mg (Esomedge- 40) · batch GD23083GlenSmith Labs Private Limited (247667) · Failed: Dissolution · CDL Kolkata
26. State not givenCo-trimoxazole Tablets IP (S- tron Tablets SS) · batch ST-223High Tech Pharma · Failed: Dissolution (Trimethopri m and Sulphametho xazole) · RDTL Guwahati
27. HaryanaLosartan Potassium Tablets IP 50 mg · batch HLOA06Hindustan Antibiotics Ltd (121001) · Failed: It fails the test ?Dissolution? as per IP · DTL Thiruvananthapuram
28. State not givenPANTOPRAZOLE (EC) & DOMPERIDONE (SR) CAPSULES IP (PANTIAC-DSR) · batch PTRC-149IOSIS REMEDIES PVT. LTD · Failed: THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR PANTOPRAZOLE AND DOMPERIDONE CAPSULES FOR THE DISSOLUTION TEST (PANTOPRAZOLE) . · State Lab Maharashtra
29. State not givenMannitol Injection I.P. (20% w/v) · batch M1M30038Kunal Remedies Pvt. Ltd (226028) · Failed: Test for Sterility · RDTL Guwahati
30. State not givenDYNACID SUSPENSION (aluminium, magnesium & simethicone oral suspension IP.) · batch BULH23008Leeford Healthcare Ltd · Failed: 1) THE SAMPLE DOES NOT COMPLY WITH I.P. REQUIREMENTS FOR TOTAL AEROBIC VIABLE COUNT IN TEST FOR MICROBIAL CONTAMINATION. 2) TOTAL AEROBIC VIABLE COUNT OF THE SAMPLE IS 20993128 CFU/GM. (1.P. LIMIT-TOTAL AEROBIC VIABLE COUNT OF THE SAMPLE - NOT MORE THAN 100 CFU/GM · State Lab Maharashtra
31. Tamil NaduAmloheart-AT [Amlodipine Besylate and Atenolol Tablets] · batch LE223030Lividus Pharmaceuticals pvt.Ltd (600096) · Failed: It fails the test ?Assay? of Amlodipine Besylate · DTL Thiruvananthapuram
32. Himachal PradeshAlbendazole Tablets IP · batch MS1AO22 01MAXTAR BIO- GENICS (173205) · Failed: Dissolution · RDTL Chandigarh
33. GujaratLevocetirizine Dihydrochloride and Montelukast Sodium Tablets IP · batch 23112701MERCURY LABORATORIES LIMITED (391510) · Failed: Dissolution of Montelukast · RDTL Guwahati
34. Tamil NaduPropylene Glycol I.P. · batch PG- IP/2023- 24/2355Manali Petrochemicals Ltd (600068) · Failed: Relative Density · CDL Kolkata
35. State not givenFrusemide Injection IP 2 ml (FRUSEMIDE) · batch FRA12347Nandani Medical Laboratories Pvt. Ltd · Failed: pH · CDL Kolkata
36. UttarakhandTranexamic Acid Tablets I.P. 500 mg · batch GT31022OMEGA PHARMA (247667) · Failed: Related substances · CDTL Mumbai
37. State not givenRosumep ASP 10/75mg Capsules · batch PBWGM04Pure & Care Healthcare Pvt. Ltd · Failed: THE SAMPLE DOES NOT COMPLY WITH IP FOR THE TEST ?RELATED SUBSTANCES ? ROSUVASTATIN?. · State Lab Maharashtra
38. DelhiNorfloxacin Oral Suspension (Ridnor Suspension) · batch RL230022RIDLEY LIFE SCIENCE PVT. LTD (110040) · Failed: Description and Total Fungal Count · RDTL Chandigarh
39. KeralaLiquid Paraffin IP · batch EP4032Repacked by :- Kerala State Drugs & Pharmaceuticals Ltd · Failed: It fails the test light absorption as per IP · DTL Thiruvananthapuram
40. State not givenIRON & FOLIC ACID SYRUP IP · batch RIFS-209Revat Laboratories Pvt. Ltd (523002) · Failed: pH and Assay of Folic Acid · CDTL Hyderabad
41. State not givenOMEPRAZOLE & DOMPERIDONE CAPSULES (REMIZOLE-D) · batch SPC230578 CSALUS PHARMACEUTICALS · Failed: THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR OMEPRAZOLE AND DOMPERIDONE CAPSULES FOR THE DISSOLUTION TEST (OMEPRAZOLE). · State Lab Maharashtra
42. State not givenLytraco 200 Itraconazole Capsules 200 mg · batch SLP-22445STERLIFE PHARMA PVT. LTD · Failed: THE SAMPLE DOES NOT COMPLY WITH B P REQUIREMENTS FOR DISSOLUTION TEST THE SAMPLE IS OFFICIAL IN B P 2021 THEREFORE THE SAMPLE IS MISBRANDED VIDE SECTION 17(b) AND RULE 96 OF THE DRUGS AND COSMETICS ACT 1940 AND RULES 1945. · State Lab Maharashtra
43. State not givenOmeford - 40 · batch SNT-220421SVR HEALTHCARE (A GMP Certified Company) · Failed: THE CONTENT OF OMEPRAZOLE IN THE SAMPLE IS LESS (l.e. 40.84% OF LABELLED AMOUNT) THAN THE SCHEDULE V LIMITS · State Lab Maharashtra
44. State not givenAmoxycillin & Potassium Clavulanate Injection IP 1.2 gm · batch 23AP04Sai Parenterals Limited (500055) · Failed: Clarity of Solution and Assay of Potassium Clavulanate · CDL Kolkata
45. Himachal PradeshAloevera+Glyce rin+Almond Oil and Vitamin-E Soap (Aqualux Soap) · batch COS-131Samanyu Skin Care · Failed: Matter insoluble in alochol · RDTL Chandigarh
46. Himachal PradeshAloevera, Glycerin and Vitamin-E Soap (D-Soft Soap) · batch COS-130Samanyu Skin Care · Failed: Matter insoluble in alochol · RDTL Chandigarh
47. Himachal PradeshAloevera, Glycerin, Vitamin-E and Jojoba oil (Synmoist Soap) · batch COS-132Samanyu Skin Care · Failed: Matter insoluble in alochol · RDTL Chandigarh
48. HaryanaPropylene Glycol USP · batch 97220141 13Shell Eastern Chemicals (138588) · Failed: Specific Gravity · CDL Kolkata
49. KeralaOseltamivir Cap IP 75 mg · batch D 0444/24- 25Supplied by Kerala Medical Services Corporation · Failed: The sample does not conform to IP standard with respect to the ?Descriptive part? of hard gelatin capsules · DTL Thiruvananthapuram
50. Himachal PradeshMontelukast Sodium and Levocetirizine Hydrochloride Tablets IP (Levmont) · batch ST23- 384DSymbiosis Pharmaceuticals Pvt. Ltd (173030) · Failed: Dissolution of Montelukast Levocetirizine hydrochloride · RDTL Guwahati
51. State not givenMONTICET-L Tablets ( Montelukast & Levocetirizine Hydrochloride Tablets) · batch TP-7581TICOMA PHARMACIA · Failed: THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR DISSOLUTION TEST FOR MONTELUKAST. THE SAMPLE IS OFFICIAL IN 1 P 2018 THEREFORE THE SAMPLE IS MISBRANDED VIDE SECTION 17(b) AND RULE 96 OF THE DRUGS AND COSMETICS ACT 1940 AND RULES 1945. · State Lab Maharashtra
52. State not givenMONTOR -LC TABLET (MONTELUKAST SODIUM & LEVOCETRIZINE DIHYDROCHLORI DE TABLET I.P.) · batch B18523001TORQUE PHARMACEUTICALS PVT. LTD · Failed: THE SAMPLE DOES NOT COMPLY WITH I P REQUIREMENTS FOR DISSOLUTION TEST · State Lab Maharashtra
53. State not givenCUCID-DM · batch CDMC501TULBROS FORMULATIONS · Failed: THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR DISSOLUTION TEST FOR OMEPRAZOLE IN ACID STAGE. · State Lab Maharashtra
54. State not givenSOFTOM-D Omeprazole and Domperidone Capsules IP · batch UD2C- 23252BULTRA DRUGS PVT. LTD · Failed: THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR OMEPRAZOLE AND DOMPERIDONE CAPSULES FOR THE DISSOLUTION TEST (OMEPRAZOLE). · State Lab Maharashtra
55. KarnatakaGlipizide and Metformin Tablets IP (Glynase-MF) · batch 4010026USV Private Limited (560058) · Failed: Dissolution of Glipizide · CDL Kolkata
56. Uttar PradeshEtamsylat Tablets 500 mg · batch ELT1104Unicure India Ltd (201301) · Failed: Description · CDTL Mumbai
57. Uttar PradeshCompound Sodium Lactate Injection I.P., 500 ml (Ringer Lactate Solution for Injection) · batch P2401050 08Vision Parenteral Pvt. Ltd (273209) · Failed: Bacterial endotoxins · CDL Kolkata
58. State not givenVirpan-40 · batch T-2306031AWHITE ENGLE LABORATORIES · Failed: THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR DISSOLUTION IN BUFFER STAGE. · State Lab Maharashtra
59. Himachal PradeshPrednisolone Tablets IP 10 mg · batch PRDT- 1007WINGS BIOTECH LLP (173205) · Failed: Assay of Prednisolone · RDTL Chandigarh
60. Himachal PradeshGentamicin Sulphate Injection I.P. 2 ml · batch 323-216Zee Laboratories Ltd (173025) · Failed: Description & Particulate matter · CDL Kolkata
61. GujaratBacotil-200 [Cefpodoxime Proxetil Tablets USP ] · batch ZTB-148Zenith Healthcare Ltd (382213) · Failed: It fails the test ?Dissolution? as per USP · DTL Thiruvananthapuram