January 2025.145 failed batches.

Batches, by manufacturer

1. Tamil NaduAceclofenac and Thiocolchico side Tablets (Speronac - MR) · batch P240502? Prosilio Pharmaceuticals Pvt. Ltd (605110) · Failed: On the received sample presence of spots were observed which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration - NSQ · State Lab Puducherry
2. PunjabCefixime and Lactic Acid Bacillus Tablets (CEFIZOC-200 LB TABLETS) · batch BT-240511A.N.D. HEALTHCARE LTD (140103) · Failed: Assay of Lactic Acid Bacillus · RDTL Chandigarh
3. State not givenDiclofenac Sodium Injection IP (AL- DICLO) · batch A-1694ALCHEMIST REMEDIES PVT. LTD · Failed: pH , Sterility, Particulate Matter, and Assay · RDTL Guwahati
4. GujaratEnteric Coated Rabeprazole Sodium And Domperidone Sustained Release Capsules (Dorab SR Capsules) · batch AFC - 111APEX FORMULATIONS PVT. LTD · Failed: Dissolution for Domperidone · CDTL Mumbai
5. GujaratItraconazole Capsules (Trax - 200) · batch AFC - 102APEX FORMULATIONS PVT. LTD · Failed: Dissolution · CDTL Mumbai
6. KarnatakaRetibak (0.2% Retinol) Face Serum · batch AHO2400 48Aarohee healthcare Private Ltd (560027) · Failed: NOT OF STANDARD QUALITY Sample does not meets the specifications wrt. To identification test for Retinol as per STP. · State Lab Drugs Control Laboratory, Telangana.
7. GujaratMontelukast Sodium and Levocetirizine Hydrochloride Dispersible Tablets (ROMILAST® L 4) · batch 18RT2401Adnova Healthcare Pvt. Ltd (391760) · Failed: Description and Uniformity of dispersion · CDTL Indore
8. State not givenDmex Colecalciferol (Vitamin D3) Tablets B.P. · batch 4D077301Aeron Lifesciences Pvt Ltd · Failed: Assay of Cholecalciferol · CDL Kolkata
9. UttarakhandItraconazole Capsules IP 100 mg · batch CTA-01Agron Remedies Pvt. Ltd (244713) · Failed: Dissolution · RDTL Guwahati
10. SikkimOndem-4 [Ondansetro n Tablets IP] · batch 2444145 1Alkem Health Science (737137) · Failed: It fails the test dissolution specified in the Laboratory Protocol as per IP · DTL Thiruvananthapuram
11. Himachal PradeshLucos-LM kid suspension · batch AMS2341 6Alop Med-Sciences Pvt Ltd (173212) · Failed: Sample does not conform to Label claim with respect to the content of Levocetirizine Hydrochloride and Montelukast in Montelukast Sodium. · DTL Chennai
12. Himachal PradeshParadolo 500 [Paracetam ol Tab IP 500 mg] · batch AGT4055 4Alventa Pharma Ltd (174101) · Failed: It fails the test ?Dissolution? as per IP · DTL Thiruvananthapuram
13. UttarakhandSucnol-O Suspension · batch SCI-2305Apple Formulations Pvt Ltd (247667) · Failed: Sample does not conform to Label Claim with respect to the content of Oxetacaine · DTL Madurai
14. Tamil NaduMupirocin Ointment IP · batch DC2437Arius Formulation Private Limited (605101) · Failed: Sample does not conform to IP Specification for Mupirocin Ointment with respect to the content of Mupirocin · DTL Madurai
15. HaryanaAceclofenac Tablets IP 100 mg · batch T042304Bengal Chemicals & Pharmaceuticals Ltd (121001) · Failed: Related substances and Assay of Aceclofenac · CDTL Mumbai
16. West BengalCefuroxime Axetil Tablets IP 500 mg · batch 4617001Bengal Chemicals and Pharmaceuticals Ltd (700054) · Failed: Dissolution · CDL Kolkata
17. State not givenTramadol Hydrochloride Injection 50 mg/ml (Tramacop ) · batch RP-04Bio Medica Laboratories Pvt. Ltd (452015) · Failed: 'Acidity or Alkalinity' and 'Assay of Tramadol' · CDL Kolkata
18. State not givenNon-Sterile Not for Intravenous Administration Concentrated Acidic Solution · batch BT229Bio Tech Formulation (520007) · Failed: Appearance of solution, assay of sodium, potassium, calcium, magnesium and total chloride. Particulate contamination and description · CDL Kolkata
19. Tamil NaduTtocin Ointment, Mupirocin with Tea Tree Oil Ointment · batch MVO-070Bonn Schetering Bio Sciences (605107) · Failed: Sample does not conform to label claim with respect to the content of mupirocin. · DTL Chennai
20. GujaratParacetamol Oral Suspension BP (100 ml) 120 mg/ 5 ml · batch ZA23019Brussels Laboratories Pvt. Ltd (382210) · Failed: Assay of Paracetamol · CDTL Mumbai
21. UttarakhandSucralfate and Oxetacain Suspension · batch SEL2401CU-V-Kar Genetic Medicines Pvt Ltd (248011) · Failed: Sample does not conform to Label claim with respect to content of Oxetacaine. · DTL Madurai
22. Himachal PradeshCiprofloxacin Injection IP · batch LV4210Captab Biotec · Failed: In test of Lactic Acid per mg of Ciprofloxacin · RDTL Chandigarh
23. Himachal PradeshOfloxacin Ophthanmic Solution IP (Ocuex Eye Drops) · batch ED4648Captab Biotec (173205) · Failed: Assay of Ofloxacin · CDL Kolkata
24. State not givenRabeprazole Sodium (as enteric coated) & Domperidone (As Sustained Release) Capsules (Rabito-DSR) · batch RTD.23010 5Cartel Laboratories · Failed: Assay of Rabeprazole Sodium · RDTL Guwahati
25. MaharashtraMetoclopramide Injection BP · batch 4EC038092Ciron Drugs & Pharmaceuticals Pvt. Ltd (401506) · Failed: Description and Particulate Contamination · CDL Kolkata
26. MaharashtraMetformin Hydrochloride Sustained Release Tablets I.P. 500mg (Conmet SR- 500) · batch C21D93400 3Concept Pharmaceuticals Ltd (431006) · Failed: Dissolution · CDL Kolkata
27. GujaratKetoya Soap · batch MO26Elegant Cosmed Pvt Ltd (360023) · Failed: sample does not conform to label claim with respect to the content of Ketoconazole · DTL Chennai
28. GujaratN-Clin Gel · batch M030Elegant Cosmed Pvt Ltd (360023) · Failed: Sample does not conform to label claim with respect to the content Clindamycin in Clindamycin Phosphate · DTL Chennai
29. JammuFlumethrin 1% Porur- On Solution · batch EE- 240906Ethicare Laboratories (180010) · Failed: Sample does not conform to Lablel Claim with respect to the content of Flumethrin. · DTL Madurai
30. PunjabKaltfer Drops Iron(III)- Hydroxide Polymaltose Complex Drops. · batch EHL- 3532Exotic Healthcare Plot No. 1305, Sector - 82, JLPL, Mohali, SAS Nagar, Punjab. . Mrkt: M/s. Curezen Pharma Pvt. Ltd (500025) · Failed: NOT OF STANDARD QUALITY The sample Does not meets the Specifications wrt. Identification Test - Negative, Assay - Nil as per STP. U/S. 17 B of Drugs and Cosmetics Act 1940. The Sample deemed to be Spurious Drug. · State Lab Drugs Control Laboratory, Telangana.
31. Tamil NaduCumox 500 · batch FDCX- 076Firstmed Therapeuticals pvt ltd (605101) · Failed: Sample does not conform to IP specification for Amoxycillin capsules with respect to Uniformity of Weight and to the content of Amoxycillin in Amoxycillin Trihydrate. · DTL Chennai
32. State not givenB&B Beaute Blanc Hair Colour Conditioner Natural Black · batch 2201202 4Gabt Co Ltd · Failed: The sample is found to contain m- phenylenediamine which must not form part of the conposition of cosmetics products as per BIS specification 4707 (Part 2): 2017, under Annex A (clauses 1,2 and 3.1), serial No.1198. · DTL Chennai
33. UttarakhandCefpodoxim e & Potassium Clavulanate Tablets · batch BPT- 3003Geenac Pharma (247667) · Failed: NOT OF STANDARD QUALITY The sample does not meets the Specifications wrt. Identification test - and Assay - for Cefpodoxime and Clavulanic Acid as per STP. U/S. 17 B of Drugs and Cosmetics Act 1940. The Sample is deemed to be Spurious Drug. · State Lab Drugs Control Laboratory, Telangana.
34. State not givenNyomi Fruit Vinegar Black Hair Gel Colour · batch 2024071 2Guangzhou Aocai Bio- Technology Co. Ltd · Failed: Sample does not conform to BIS Specification for Oxidation Hair dye with respect to the content of Phenyl Methyl Pyrazole. · DTL Chennai
35. State not givenAmbroxol HCL, Levosalbutamol sulphate and Guaiphenesin Drops (Breath- LS Drops ) · batch HBD 2403HIPPO LABS PVT. LTD · Failed: Description · CDL Kolkata
36. State not givenGentamicin Injection IP- 2ml · batch HLI615FHimalaya Meditek Private Ltd (248197) · Failed: sample does not Conform to the requirement for PH · King Institute Chennai
37. State not givenGentamicin Injection IP- 2ml · batch HLI623FHimalaya Meditek Private Ltd (248197) · Failed: sample does not Conform to the requirement for PH · King Institute Chennai
38. State not givenGentamicin Injection IP- 2ml · batch HLI628FHimalaya Meditek Private Ltd (248197) · Failed: sample does not Conform to the requirement for PH · King Institute Chennai
39. State not givenGentamicin Injection IP- 2ml · batch HLI620FHimalaya Meditek Private Ltd (248197) · Failed: sample does not Conform to the requirement for PH · King Institute Chennai
40. State not givenAspirin Tablets · batch TAS2301 0ALHindustan Laboratories Limited · Failed: Sample does not conform to IP Specification for Aspirin Tablets with respect to the content of Aspirin. · DTL Madurai
41. Himachal PradeshLukus · batch G198INDKUS Biotech India (173001) · Failed: Sample does not conform to IP specification for Luliconazole Cream with respect to the content of Luliconazole · DTL Madurai
42. Himachal PradeshCefixime & Ofloxacin Tablets (CEPHAFLU- 400) · batch CT5853AJ.M.LABORATORIES (173211) · Failed: Assay of Cefixime · CDL Kolkata
43. Himachal PradeshBETAHISTI NE DIHYDROC HLORIDE TABLETS IP (Betahox- 8) · batch T-18946Jackson Laboratories Pvt Ltd (176501) · Failed: On the received sample presence of spots were observed which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discolouration. - NSQ · State Lab Puducherry
44. PunjabFexofenadin e Hydrochlori de Tab IP 180 mg [Fexodil- 180] · batch T 3105Jackson Laboratories Pvt Ltd (143001) · Failed: It fails the test ?Dissolution? as per IP · DTL Thiruvananthapuram
45. PunjabAlbendazole Tablets IP 400 mg (Albendazole 400) · batch T-3159Jackson Laboratories Pvt.Ltd (143001) · Failed: Dissolution · RDTL Guwahati
46. Tamil NaduPodine-M · batch PM 04Karlin Pharmaceuticals & Exports Private Limited (600087) · Failed: sample does not conform to label claim with respect to the content of available iodine in povidone iodine · DTL Chennai
47. UttarakhandOndansetro n orally disintegratin g tablets IP 4 mg · batch T-15842Karnani Pharmaceuticals Pvt.Ltd (248011) · Failed: NOT OF STANDARD QUALITY While opening the strip, it is found that the tablets are not in intact condition. Received 50 tablets, out of 50 tablets, 40 tablets are not in intact condition. Hence sample is of Not of Standard Quality with respect to Description test parameter. · State Lab Drugs Control Laboratory, Telangana.
48. KeralaGlimepiride Tablet IP · batch D2854/24 -25Kerala Medical Services Corporation · Failed: The sample does not conform to IP standards with respect to ?Descriptive Part? for tablets. · DTL Thiruvananthapuram
49. KeralaGlimepiride Tablet IP 1 mg · batch D2721/24 -25Kerala Medical Services Corporation · Failed: The sample does not conform to IP standards with respect to ?Descriptive Part? for tablets. · DTL Thiruvananthapuram
50. KeralaGlimepiride Tablet IP 1 mg · batch D2505/24 -25Kerala Medical Services Corporation · Failed: It fails the test dissolution and ?Descriptive Part? specified in the Laboratory Protocol as per IP · DTL Thiruvananthapuram
51. KeralaLosartan Potassium Tab IP 25 mg · batch D 2615/24- 25Kerala Medical Services Corporation · Failed: It fails the ?Descriptive Part? for the tablets as per IP , tablets should have sufficient hardness for handling without crumbling and breaking · DTL Thiruvananthapuram
52. KeralaVitamin B Complex Tablets NFI · batch S0016/24 -25Kerala Medical Services Corporation · Failed: The sample does not conform to IP standards with respect to ?Descriptive Part? for tablets. · DTL Thiruvananthapuram
53. KeralaCetirizine Syrup IP · batch CE3010Kerala State Drugs and Pharmaceuticals Limited (688522) · Failed: It fails the test ?Assay? as per IP · DTL Thiruvananthapuram
54. KeralaCetirizine Syrup IP · batch CE 3008Kerala State Drugs and Pharmaceuticals Limited (688522) · Failed: It fails the test Assay and content of packaged dosage forms specified in the laboratory protocol as per IP · DTL Thiruvananthapuram
55. KeralaCetirizine Syrup IP · batch CE4019Kerala State Drugs and Pharmaceuticals Limited (688522) · Failed: It fails the tests Microbial contamination in non- sterile products as per IP · DTL Thiruvananthapuram
56. Madhya PradeshNimesulide & Paracetamol Tablets (SOMOO) · batch T-24004Kshipra Drugs Pvt. Ltd (455001) · Failed: Disintegration · RDTL Guwahati
57. Tamil NaduMecobalami n Sublingual Tablets 1500 mcg (Re- Xite BTX) · batch D240601 9LINUX LIFE SCIENCES PVT LTD (605107) · Failed: On the received sample, Presence of Spot defect was observed which should not be present as per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration.- NSQ · State Lab Puducherry
58. UttarakhandCalcium 500 mg with Vitamin D3 250 IU Tablets IP · batch LMT240431Life Max Cancer Laboratories (249403) · Failed: Identification and Assay of Vitamin D3 and Dissolution of Calcium · RDTL Guwahati
59. UttarakhandLosartan Tablets IP 50 mg · batch LMT240826Life Max Cancer Laboratories (249403) · Failed: Dissolution · RDTL Guwahati
60. UttarakhandZinc Sulphate Dispersible Tablets IP 20 mg · batch LMT240811Life Max Cancer Laboratories (249403) · Failed: Uniformity of dispersion & Disintegration · RDTL Guwahati
61. Himachal PradeshRabeprazole Sodium 20mg (EC) & Domperidone 10mg (IR), Domperidone 20mg (SR) Capsules (Rebast-ARD) · batch LC-6943Lifevision Healthcare (174103) · Failed: Dissolution · RDTL Guwahati
62. Tamil NaduCalcium Carbonate & Vitamin D3 Tablets (VICTOCAL ? D3) · batch MDP - 746MEDINOK HEALTHCARE PVT LTD (605009) · Failed: The sample received is labelled as CALCIUM CARBONATE & VITAMIN D3 TABLETS, however CALCIUM CARBONATE & VITAMIN D3 TABLETS is an official IP monograph (2022) hence should be labelled as CALCIUM AND VITAMIN D3 TABLETS IP. - Label issue · State Lab Puducherry
63. HaryanaTicagrelor Tablets IP 90 mg (Tigamon 90) · batch MT230087MONIQUE PHARMACEUTICAL S PVT. LTD (121004) · Failed: Dissolution · CDL Kolkata
64. Himachal PradeshAceclofenac , Paracetamo l and Chlorzoxazo ne Tablets (Megaceclo MR) · batch AMT2407 160Marine Medicare Pvt. Ltd (174103) · Failed: On the received sample presence of spots observed which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration- NSQ · State Lab Puducherry
65. Himachal PradeshRabeprazole Sodium Injection I.P. · batch MD23H13Martin & Brown Bio-Sciences Pvt. Ltd (173205) · Failed: pH, Water, Clarity of Solution, Particulate matter and Assay of Rabeprazole Sodium · CDL Kolkata
66. State not givenCefixime & Lactic Acid Bacillus Dispersible Tablets · batch MLS- 24506Maskon Life sciences pvt ltd (247667) · Failed: Sample does not conform to label claim with respect to the content of Anhydrous Cefixime in Cefixime Trihydrate · DTL Madurai
67. MaharashtraCo- Trimoxazole Tablets IP 480mg · batch MT402Maxwell Lifescience Pvt Ltd (401506) · Failed: Sample does not conform to IP Specification for Co- Trimoxazole Tablets with respect to Dissolution for Trimethoprim and Sulphamethoxazole · DTL Chennai
68. Himachal PradeshMupirocin Ointment IP · batch ME-41Maxwell pharma (173220) · Failed: Sample does not conform to IP specification for Mupirocin Ointment with respect to identification and content of mupirocin · DTL Madurai
69. Himachal PradeshTuclav -CV 625[ Amoxycillin and Potassium Clavulanate Tab IP · batch MYRTAB -618Mayer Lab (173213) · Failed: It fails the test Dissolution and Assay as per IP · DTL Thiruvananthapuram
70. Tamil NaduClopidogrel Tablet I.P 75 mg (Maxgrel - 75) · batch MDP - 309Medinok Healthcare Pvt. Ltd (605009) · Failed: (i) On the received sample, Presence of Spot and discoloration defects were observed which should not be present as per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration. (ii)The label of the container in the drug is mentioned as 'Approved colour used' but the common name of the permitted colour used in the formulation as prescribed under rule 127 (2) of the drug rule was not mentioned. (iii) On the received sample, The name of the manufacturer and as prescribed under 96 (1) (iv) of the Drugs and Cosmetics Act. (iv) On the received sample,the label details of the primary packing does not match with that of the secondary packing (Excipients ?q.s is not mentioned in primary packing)- NSQ the address of the premises of the manufacturer appears in an inconspicuous manner on the label whereas they should appear in a conspicuous manner · State Lab Puducherry
71. Tamil NaduMetoprolol Succinate Extended Release & Telmisartan Tablets (Leaftel Beta ? 25) · batch MP - 231584Medistark Biotech Pvt. Ltd (605111) · Failed: The label of the container in the drug is mentioned as 'Approved colour used' but the common name of the permitted colour used in the formulation as prescribed under rule 127 (2) of the drug rule was not mentioned. - Misbranded · State Lab Puducherry
72. Tamil NaduPregabalin (SR) & Methylcobal amin Tablet (Mecoben ? PG) · batch MP - 240724Medistark Biotech Pvt. Ltd (605111) · Failed: The label of the container in the drug is mentioned as 'Approved colour used' but the common name of the permitted colour used in the formulation as prescribed under rule 127 (2) of the drug rule was not mentioned. - Misbranded · State Lab Puducherry
73. State not givenLiquid Paraffin IP 400 ml · batch HP 24002Multicure Pharma Private Limited (508116) · Failed: It fails the tests ?Weight per ml and ?Light Absortion? as per IP · DTL Thiruvananthapuram
74. MaharashtraHYPODERMIC SYRINGE WITH NEEDLE (Nusafe 2ml) · batch 2407154NUBENO HEALTHCARE PRIVATE LIMITED (441108) · Failed: Sterility · RDTL Guwahati
75. Himachal PradeshMupirocin Ointment IP 2% w/w · batch NO33015 6Nanz med Science Pharma Pvt Ltd (173025) · Failed: Sample does not conform to IP specification for Mupirocin Ointment with respect to the content of mupirocin · DTL Madurai
76. Himachal PradeshPovinanz Gargle · batch ES40030Nanz med Science Pharma Pvt Ltd (173025) · Failed: sample does not conform to label with respect to the content of available iodine in povidone-iodine · DTL Chennai
77. State not givenDexamethasone Sodium Phosphate Injection (Dexamethason e 30ml) · batch DX-18New Lab Industry · Failed: SPURIOUS pH, Extractable volume, Particulate matter, Sterility, Identification and Assay of Dexamethasone Sodium Phosphate and Description · CDL Kolkata
78. State not givenGentamicin Injection I.P. 30 ml · batch GM-19New Lab Industry · Failed: SPURIOUS Particulate Matter, Extractable Volume, Composition of Gentamicin Sulphate, Identification and Assay of Gentamicin Sulphate and Description · CDL Kolkata
79. GujaratNozal · batch 4246Olcare Laboratories (363035) · Failed: Sample does not conform to BP Specification for Ketoconazole cream with respect to the content of Ketoconazole · DTL Chennai
80. GujaratNozal Cream · batch 3447Olcare Laboratories (363035) · Failed: Sample does not conform to BP Specification for Ketoconazole Cream with respect to the content of Ketoconazole. · DTL Chennai
81. HaryanaSpironolacto ne Tablets IP · batch T- 2403993Oscar Remedies Pvt. Ltd (135001) · Failed: Sample does not conform to IP specification for Spironolactone Tablets with respect to Dissolution · DTL Chennai
82. PunjabCalcium Aspartate, Calcium Orotate, Calcitriol, Minerals And Vitamins Tablets · batch EZF-1989Overseas Healthcare Pvt. Ltd (144410) · Failed: Assay/content of 'Calcitriol' and 'Zinc' · CDL Kolkata
83. Himachal PradeshCLAVPARK -LB 625mg (Amoxycillin , Potassium Clavulanate & Lactic Acid Bacillus Tab) · batch CHTJ426 0Park Pharmaceuticals · Failed: Does not confirm to claim · SDTL Kolkata
84. West BengalCompound Sodium Lactate Injection I.P (Ringer?s Lactate I.P) · batch 03BF224 1Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Test for Sterility · State Lab Karnataka
85. West BengalCompound Sodium Lactate Injection I.P (Ringer?s Lactate I.P) · batch 03BF232 8Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Bacterial Endotoxin Test? and ?Test for Sterility · State Lab Karnataka
86. West BengalCompound Sodium Lactate Injection I.P (Ringer?s Lactate I.P) · batch 03BP006 0Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Test for Sterility · State Lab Karnataka
87. West BengalCompound Sodium Lactate Injection I.P (Ringer?s Lactate I.P) · batch 03BF231 9Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Bacterial Endotoxins Test · State Lab Karnataka
88. West BengalCompound Sodium Lactate Injection I.P (Ringer?s Lactate I.P) · batch 03BF238 9Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Test for Sterility · State Lab Karnataka
89. West BengalCompound Sodium Lactate Injection I.P (Ringer?s Lactate I.P) · batch 03BF231 8Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Bacterial Endotoxins Test? and ?Test for Sterility · State Lab Karnataka
90. West BengalCompound Sodium Lactate Injection I.P (Ringer?s Lactate I.P) · batch 03BF225 6Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Test for Sterility · State Lab Karnataka
91. West BengalCompound Sodium Lactate Injection I.P (Ringer?s Lactate I.P) · batch 03BF232 9Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Bacterial Endotoxin Test? and ?Test for Sterility · State Lab Karnataka
92. West BengalCompound Sodium Lactate Injection I.P (Ringer?s Lactate I.P) · batch 03BF221 0Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Test for Sterility · State Lab Karnataka
93. West BengalCompound Sodium Lactate Injection I.P (Ringer?s Lactate I.P) · batch 03BF234 2Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Sterility Test? · State Lab Karnataka
94. West BengalCompound Sodium Lactate Injection I.P (Ringer?s Lactate I.P) · batch 03BF225 4Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Sterility Test · State Lab Karnataka
95. West BengalCompound Sodium Lactate Injection I.P (Ringer?s Lactate I.P) · batch 03BF236 9Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Bacterial Endotoxin Test · State Lab Karnataka
96. West BengalCompound Sodium Lactate Injection I.P (Ringer?s Lactate I.P) · batch 03BP005 7Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Test for Sterility · State Lab Karnataka
97. West BengalCompound Sodium Lactate Injection I.P (Ringer?s Lactate I.P) · batch 03BF226 0Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Test for Sterility · State Lab Karnataka
98. West BengalCompound Sodium Lactate Injection I.P (Ringer?s Lactate I.P) · batch 03BP012 0Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Test for Sterility · State Lab Karnataka
99. West BengalCompound Sodium Lactate Injection I.P (Ringer?s Lactate I.P) · batch 03BP011 5Paschim Banga Pharmaceuticals, (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Test for Sterility and Bacterial Endotoxins Test · State Lab Karnataka
100. Tamil NaduAmoxycillin Dispersible Tablets IP 125 mg · batch PGA24- 006Pondchy Pharmaceuticals (605110) · Failed: Sample does not conform to IP Specification for Dispersible Tablets with respect to uniformity of Dispersion and Disintegration · DTL Chennai
101. Tamil NaduAmoxycillin Dispersible Tablets IP 125 mg · batch PGA24- 001Pondchy Pharmaceuticals (605110) · Failed: Sample does not conform to IP Specification for Dispersible Tablets with respect to uniformity of Dispersion and Disintegration · DTL Chennai
102. Himachal PradeshHyoscine Butylbromide Tablets IP (BUSCOPRIME -10 TABLETS) · batch PT-102441Primus Pharmaceuticals (173030) · Failed: Assay of Hyoscine Butylbromide · RDTL Chandigarh
103. Tamil NaduAmoxycillin Trihydrate Capsules (RIMOXIN) · batch RIX-040RIPPON LABORATORIES No.44 (605110) · Failed: The sample received is labelled as AMOXYCILLIN TRIHYDRATE CAPSULES , however AMOXYCILLIN TRIHYDRATE CAPSULES is an official IP monograph (2022) hence should be labelled as AMOXYCILLIN TRIHYDRATE CAPSULES IP.- Label issue · State Lab Puducherry
104. State not givenCalcium Gluconate Injection I.P. 10% w/v (REOCAL) · batch CG-386Rathi Laboratories(Hindust an) Pvt. Ltd (800013) · Failed: pH, Particulate matter, Sterility and Description · CDL Kolkata
105. State not givenMobicool TM-S Suspenion · batch RL- 231203Rednex pharmaceuticals · Failed: Sample does not conform to Label claim with respect to content Oxetacaine · DTL Madurai
106. UttarakhandAceclofenac & Drotaverine Hydrochlori de Tablets (100 mg/ 80 mg) · batch PRT2401 -01Regent Ajanta Biotech (247667) · Failed: Description · State Lab Karnataka
107. State not givenLuliconazole Cream IP 1% w/w · batch 2946Regent Ajanta Biotech (247667) · Failed: sample does not Conform to IP Specification for Luliconazole Cream with respect to the PH of 10% w/v solution. · DTL Madurai
108. Andhra PradeshNorfloxacin Tablets IP 400mg · batch RNFT- 017Revat Laboratories Pvt.Ltd (523002) · Failed: NOT OF STANDARD QUALITY Dissolution test does not complies for Norfloxacin Tablets IP at S2 Level as per IP 2022. · State Lab Drugs Control Laboratory, Telangana.
109. Andhra PradeshNorfloxacin Tablets IP 400mg · batch RNFT- 014Revat Laboratories Pvt.Ltd (523002) · Failed: NOT OF STANDARD QUALITY Dissolution test does not complies for Norfloxacin Tablets IP at S2 level as per IP 2022. · State Lab Drugs Control Laboratory, Telangana.
110. GujaratAmlodipine Tablets IP 5 mg (Systogan-5) · batch CT062Ryzer Pharmaceutical Pvt. Ltd (382845) · Failed: Related substances · CDTL Mumbai
111. State not givenIron Sucrose Injection USP 100mg/5ml · batch 24RS04SAI Parenterals Limited (500055) · Failed: pH · CDL Kolkata
112. State not givenIron Sucrose Injection USP 100mg/5ml · batch 24RS08SAI Parenterals Limited (500055) · Failed: pH · CDL Kolkata
113. Himachal PradeshMupirocin Ointment IP · batch SO-033SB Lifesciences pvt ltd (173205) · Failed: Sample does not conform to IP specification for Mupirocin Ointment with respect to the content of Mupirocin · DTL Madurai
114. State not givenGentamicin Injection IP- 2ml · batch 24BUE74SVP Life Sciences · Failed: Sample does not conform to the requirement for PH. · King Institute Chennai
115. State not givenGentamicin Injection IP- 2ml · batch 24BUF83SVP Life science · Failed: sample does not Conform to the requirement for PH · King Institute Chennai
116. State not givenGentamicin Injection IP- 2ml · batch 23BUH50SVP Life science · Failed: sample does not Conform to the requirement for PH · King Institute Chennai
117. Himachal PradeshCeftriaxone Injection IP (Cefiglad-1 Injection) · batch SRIJ240041SYSTOLE REMEDIES PVT. LTD (173030) · Failed: Particulate matter · RDTL Chandigarh
118. Andhra PradeshSodium Chloride and Glycerine Sterile Diluent for fowl pox vaccine and its combinations for wing web application · batch ACF24159Safe Parenterals Pvt. Ltd (522408) · Failed: Description, Appearance of solution and Particulate matter · CDL Kolkata
119. TelanganaParenteral preparations , Piperacillin & Tazobactam Injection I.P. 4.5 gm · batch 24PT41Sai parenterals limited (500055) · Failed: NOT OF STANDARD QUALITY Test for sterility does not complies as per IP for the sample Piperacillin and Tazobactam injection IP 4.5 gm · State Lab Drugs Control Laboratory, Telangana.
120. Himachal PradeshOfloxacin & Ornidazole Tablets IP (Zeof-O) · batch SCZAG230 07Sano-Cito Therapeutics Inc (173211) · Failed: Dissolution · CDL Kolkata
121. Tamil NaduParacetamo l, Phenylephri ne HCl, Caffeine & Diphenhydr amine HCl Tablets (CINKOLD) · batch SG034B0 3Sharun Pharmaceuticals Pvt Ltd (605102) · Failed: NOTE:(i) On the received sample, Presence of Spot defect was observed which should not be present as per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration. (ii)The label of the container in the drug is mentioned as 'Approved colour used' but the common name of the permitted colour used in the formulation as prescribed under rule 127 (2) of the drug rule was not mentioned. vel - NSQ · State Lab Puducherry
122. HaryanaMonopropylene Glycol USP · batch 9971702044Shell Eastern Chemicals (138588) · Failed: Water · CDL Kolkata
123. GujaratLorazepam Tablets IP 1 mg (PROLINE - 1) · batch 06P23T03Shine Pharmaceuticals Limited (391240) · Failed: Assay · CDTL Mumbai
124. Himachal PradeshAceclofenac, Paracetamol and Serratiopeptidas e Tablets (ST- SP Tablets) · batch NBT- 240624Soft Touch Pharmaceuticals India Lt (173234) · Failed: Assay of Aceclofenac and Paracetamol · RDTL Chandigarh
125. TelanganaPantoprazol e tablets IP · batch P03524Spansules formulations India Pvt.Ltd (502325) · Failed: NOT OF STANDARD QUALITY Assay and Dissolution test does not complies for Pantoprazole tablets as per IP 2022. · State Lab Drugs Control Laboratory, Telangana.
126. State not givenDiclofenac Sodium Injection I.P (DEPAIN-75) · batch SNDA23801Srinija Parenterals (522009) · Failed: pH · CDL Kolkata
127. Tamil NaduXputum-LS Syrup · batch 24-XLS- 010Stedman Pharmaceuticals Pvt Ltd (603110) · Failed: Sample does not conform to Label Claim With respect to content of Levosalbutamol in Levosalbutamol Sulphate. · DTL Madurai
128. State not givenBetamethas one Valerate Oilment IP 0.1% w/w · batch BO6Syndicate Pharma (452015) · Failed: Sample does not conform to IP specification for Betamethasone Valerate Ointment with respect to the content of Betamethasone in Betamethasone Valerate. · DTL Chennai
129. State not givenBetamethas one Valerate Ointment IP 0.1% w/w · batch B76Syndicate Pharma (452015) · Failed: Sample does not conform to IP Specification for Betamethasone Valerate Ointment with respect to the content of Betamethasone in Betamethasone Valerate. · DTL Chennai
130. PunjabClobazam Tablets IP 5 mg · batch TPT-012058Tanpal Pharmaceuticals (147201) · Failed: Dissolution · CDL Kolkata
131. PunjabPyridoxine Tablets IP 10 mg (Pyrotan-10) · batch TPT- 0102064Tanpal Pharmaceuticals (147201) · Failed: Assay of Pyridoxine · RDTL Chandigarh
132. PunjabRamipril Tablets IP 5 mg · batch TPT- 0102040Tanpal Pharmaceuticals (147201) · Failed: Assay of Ramipril · RDTL Chandigarh
133. State not givenMetoprolol Succinate Prolonged Release Tablets IP 25 mg · batch DT 2403Triveni Formulations Limited (521212) · Failed: Dissolution · CDTL Hyderabad
134. State not givenTELMA AM · batch 5240367Under Investigation · Failed: Does not confirm to I.P. · SDTL Kolkata
135. UttarakhandFexofenadine Hydrochloride Tablets I.P. 120 mg. · batch UGT231163Unimarck Healthcare Ltd (249403) · Failed: Dissolution · RDTL Guwahati
136. Tamil NaduVIP Hair Colour Shampoo · batch B107CVIMAC (600077) · Failed: Sample does not conform to BIS specification for oxidation hair dye with respect to the content of phenyl methyl pyrazolone and Resorcinol · DTL Chennai
137. Himachal PradeshCefpodoxim e Proxetil Tablets IP 200 MG (RIZDOX- 200) · batch VCT/129Vats Biotech Pvt Ltd (173211) · Failed: On the received sample Discoloration,rough surface and picking defects were observed which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration (iv)Picking and (vii)Rough surface. - NSQ · State Lab Puducherry
138. Himachal PradeshMontelukast & Levocetirizine Hydrochloride Tablets IP (SOLIKAST-L) · batch VLB-GT- 2219Vee Laboratories (173211) · Failed: Dissolution · RDTL Guwahati
139. Himachal PradeshPC-WIN- 650 · batch VGT2316 99CVrindavan Global (173205) · Failed: The sample does not conform to IP 2022 with respect to the test for Dissolution · Drug Testing Laboratory Srinagar (J&K) vide report on Form 13 bearing No. L/DA/2024-25/1593 Dated: 29.10.2024. (Report attached as Annexure A)
140. UttarakhandCoscopin Cold Plus · batch CSP2300 1Windlas Biotech Limited (248110) · Failed: Sample does not conform to Label claim with respect to the content of Phenylephrine Hydrochloride · DTL Madurai
141. Himachal PradeshParacetamo l, Cetirizine Hydrochlori de & Phenylephri ne Hydrochlori de Tablets (WINCOLD Z) · batch WNZT- 3240Wings Biotech LLP (173205) · Failed: On the received sample presence of spots were observed which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration - NSQ · State Lab Puducherry
142. Himachal PradeshAmbroxol HCl, Guaiphenesin, Terbutaline Sulphate and Menthol Syrup (BRONKOREX AM Syrup) · batch BALS-2005Wings Novitas Healthcare LLP (173205) · Failed: Assay of Ambroxol Hydrochloride and Terbutaline Sulphate · RDTL Chandigarh
143. Himachal PradeshVitamin B- Complex with Vitamin C and Zinc Capsules (Nutribest-Plus ) · batch 1724-226ZEE LABORATORIES LTD (173025) · Failed: Assay of 'Cyanocobalami n' and 'Calcium Pantothenate' · CDL Kolkata
144. Himachal PradeshThiamine Hydrochlori de Tablets IP 100mg (KTHAMINE -100) · batch ZRST- 1361ZRS PHARMACEUTICALS INDIA PVT LTD (173220) · Failed: (i) On the received sample, Presence of Spot defect was observed which should not be present as per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of Spot/discoloration. (ii)The label of the container in the drug is mentioned as 'Approved colour used' but the common name of the permitted colour used in the formulation as prescribed under rule 127 (2) of the drug rule was not mentioned. (iii) The label claim of the drug states 'Thiamin hydrochloride IP 100mg' instead of ' Thiamine Hydrochoride IP 100mg' but the proper name of the drug should be written as prescribed under 96(1),(i)(A) of The Drugs and Cosmetics Act. (iv) The label claim of the received sample states Thiamin Hydrochloride IP 100mg whereas in the IP monograph, The usual strength of the thiamine tablet is stated as 5mg, 10mg, 50mg. Hence,the Strength of the sample received does not match the usual strength as mentioned in the IP monograph. - NSQ · State Lab Puducherry
145. GujaratLevocetirizine Hydrochloride & Montelukast Sodium Tablets IP (Montura-L) · batch ZT23547CZenon Lifesciences Pvt. Ltd (382220) · Failed: Dissolution of Montelukast · RDTL Guwahati