February 2025.103 failed batches.

Batches, by manufacturer

1. GujaratBacillus clausii Spores Suspension (Bactogermina Oral Suspension 2 Billion/ 5 ml) · batch AFL241415AARMED FORMULATIONS PVT. LTD · Failed: Assay as "Viability" (Total viable count) · CDTL Mumbai
2. Tamil NaduRABISAP tablets Rabeprazole Gastro Resistant Tablets IP 20 mg · batch AST 24524AASSK Pharmaceuticals Pvt Ltd (600122) · Failed: NOT OF STANDARD QUALITY Sample does not complies in respect of Dissolution test as per IP · State Lab Drugs Control Laboratory, Telangana.
3. GujaratLinezolid IV Injection 600 mg/ 300 ml (ABAZOLID) · batch A4544004Abaris Healthcare Pvt. Ltd (382740) · Failed: "Related substances" · CDTL Mumbai
4. Himachal PradeshRabicy-20 Tablets Rabeprazole Tablets IP 20 mg · batch AT2403 4149Accura Care Pharmaceuticals Pvt Ltd (173030) · Failed: NOT OF STANDARD QUALITY &MISBRADED 1. Sample does not complies in respect of Dissolution test as per IP 2. The drug Rabeprazole Sodium is official in IP. But the product titile Rabeprazole Sodium IP is not mentioned on the product label. Hence the subject drug is Misbranded as per section 17 of Drugs & Cosmetics Act 1940, as it is not labeled in the prescribed manner · State Lab Drugs Control Laboratory, Telangana.
5. GujaratWholeshield Refire Premium Herbal Blend Capsule · batch EAHC24021Aeron Lifescience Pvt. Ltd (382430) · Failed: Assay · CDL Kolkata
6. GujaratWholeshield Refire Premium Herbal Blend Capsule · batch EAHC24020Aeron Lifescience Pvt. Ltd (382430) · Failed: Assay · CDL Kolkata
7. Himachal PradeshCalcium & Vitamin D3 Tablets IP · batch PGT246 72Affy Parenterals (173205) · Failed: The sample does not conform to the IP 2022 requirement with respect to uniformity of weights · DTL Srinagar (J&K)
8. Himachal PradeshCefdoxi-CV-50 dry syrup Cefpodoxime & Potassium Clavulanate for Oral Suspension · batch CD0724 002FAlencure Biotech Pvt Ltd (173030) · Failed: NOT OF STANDARD QUALITY 1. Description Dose Not complies- Orange -colored suspension, that is not uniformly resuspendable after reconstitution with the sterile water ampoule provided in the pack A clear phase separation is observed immediately after reconstitution. Additionally, the reconstituted suspension exhibits an obnoxious/ unacceptable odour. 2. Assay Does Not Complies: The Assay content found is not within the prescribed limit. · State Lab Drugs Control Laboratory, Telangana.
9. Himachal PradeshACEGLO tablets Aceclofenac and Paracetamol Tablets · batch ATG4I7 87Anrose pharma (173205) · Failed: MISBRANDED DRUG The drug product Aceclofenac and Paracetamol Tablets is official i.e. included in the Addendum 2024 to Indian Pharmacopoeia 2022 effective from 1st July, 2024-current edition of IP and as required as per Second Schesule of the Drugs and Cosmetics Act, 1940. The said drug product shall comply with the standards set out in the Indian Pharmacopoeia .But the designation IP in conjunction with the official title Aceclofenac and Paracetamol tablets on the label of the drug product was not menttioned as an indication that the drug product purports to comply with IP standards. Hence the drug product shall be deemed to be Misbranded Drug as per Secton 17 of Drugs and Cosmetics Act, as it is not labeled in the prescribed manner. · State Lab Drugs Control Laboratory, Telangana.
10. UttarakhandVitamin B1, Vitamin B2, Nicotinamide, Vitamin B6, Vitamin B12 & Calcium D- Pantothenate Syrup (B- Complex Syrup), · batch BOB-2423Apple Formulations Pvt. Ltd (247667) · Failed: Assay of Calcium D-Pantothenate · CDL Kolkata
11. UttarakhandVitamin B1, Vitamin B2, Nicotinamide, Vitamin B6, Vitamin B12 & Calcium D-Pantothenate Syrup (B- Complex Syrup) · batch BOB-2452Apple formulation Pvt. Ltd (247667) · Failed: Assay of Vitamin B12 · CDL Kolkata
12. UttarakhandVitamin B1, Vitamin B2, Nicotinamide, Vitamin B6, Vitamin B12 & Calcium D- Pantothenate Syrup (B- Complex Syrup) · batch BOB-2438Apple formulations Pvt. Ltd (247667) · Failed: Assay of Vitamin B12 · CDL Kolkata
13. UttarakhandVitamin B1, Vitamin B2, Nicotinamide, Vitamin B6, Vitamin B12 & Calcium D- Pantothenate Syrup (B- Complex Syrup) · batch BOB-2424Apple formulations Pvt. Ltd (247667) · Failed: Assay of Calcium D-Pantothenate · CDL Kolkata
14. GujaratLevocetirizine Dihydrochloride Tablets IP 5 mg (Alercet-5) · batch 2411110Brij Healthcare Pvt. Ltd (383001) · Failed: Dissolution · CDTL Indore
15. TelanganaMoovrun tablets Diclofenac Sodium and Paracetamol tablets · batch DFP- 2403Concord Drugs Ltd (501505) · Failed: MISBRANDED DRUG The drug product Diclofenac sodium and Paracetamol tablets is offcially included in the current edition of Indian Pharmacopoeia IP 2022 and as required as per second schedule of the Drugs and Cosmetics Act, 1940 the said Product shall comply with the standards set out in the Indian Pharmacopoeia. But the designation IP in conjunction with the offcial title Diclofenac sodium and Paracetamol tablets on the label of the drug product was not mentioned as an indication that the drug product purports to comply with the IP satadards. Hence the drug product shall deemed to be MISBRANDED DRUG as per section 17 of Drugs and Cosmetics Act, 1940 as it is not labelled in the prescribed Manner. · State Lab Drugs Control Laboratory, Telangana.
16. Himachal PradeshTelfine -CT · batch T-1150Cosmas Pharmacls Ltd (174103) · Failed: The sample does not conform w.r.t the Assay contents of Telmisartan and Chlorthalidone · DTL Srinagar (J&K) & MDTL Kathua (J&K)
17. State not givenFolic Acid Tablets IP 5 mg [Foldivit] · batch FTV240 04Danish Healthcare (p) Ltd (456010) · Failed: It fails the test ?Dissolution? Specified in the laboratory protocol as per IP · DTL Thiruvananthapuram
18. GujaratClonazepam Tablets IP 0.5 mg (NOZIM-0.5) · batch DT40078Elikem Healthcare Private Limited (382715) · Failed: Dissolution · CDTL Indore
19. UttarakhandCompound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) · batch DCSL3021Eurolife Healthcare Pvt. Ltd (247667) · Failed: Particulate Contamination, Bacterial endotoxin test, Sterility and Description · CDL Kolkata
20. Himachal PradeshLignocaine Hydrochloride Gel IP 5 % w/v (30 g) · batch G407Gnosis Pharmaceuticals Pvt. Ltd (173030) · Failed: "pH" · CDTL Mumbai
21. Himachal PradeshCompound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection ) (Hi-Ring-RL ) · batch F41799HIGGS HEALTHCARE · Failed: Bacterial endotoxins · CDL Kolkata
22. Himachal PradeshCompound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection ) (Hi- Ring-RL) · batch F41746HIGGS HEALTHCARE · Failed: Bacterial endotoxins · CDL Kolkata
23. Himachal PradeshParacetamol Tab IP 500 mg · batch PAK 551Healer?s Lab · Failed: It fails the test ?Dissolution? Specified in the laboratory protocol as per IP · DTL Thiruvananthapuram
24. Himachal PradeshAdrenaline Bitartrate Injection I.P. 1ml · batch HIAN24005AHealth Biotech Ltd (173205) · Failed: Appearance of solution, Particulate matter and Description · CDL Kolkata
25. Himachal PradeshBupivaaine Hydrochloride in Dextrose Injection USP · batch HIBU23010Health Biotech Ltd (173205) · Failed: Particulate Matter in Injection and Description · CDL Kolkata
26. State not givenParacetamol & Diclofenac Sodium Tablets I.P. (IG Pyrin) · batch IGN-2602I.G. PHARMA LTD · Failed: Dissolution of Paracetamol & Diclofenac Sodium · RDTL Guwahati
27. PunjabPhenytoin Tablets IP 100 mg · batch T-1150Jackson Laboratories Pvt Ltd (143001) · Failed: The sample does not conforms w.r.t the test for description · DTL Srinagar (J&K) & MDTL Kathua (J&K)
28. PunjabNitrofurantoin Tablets IP 100mg · batch T-2485Jackson Laboratories Pvt.Ltd (143001) · Failed: Dissolution · RDTL Guwahati
29. GujaratMydew Ultra Syndet Bar · batch 2387Jain Soap · Failed: The sample does not conform to the test pH as per manufacturer?s specification for Mydew Ultra Syndet Bar as specified in the Laboratory Protocol · DTL Thiruvananthapuram
30. KarnatakaGlimepiride Tablets I.P. 1mg · batch GLI10823KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LIMITED (560058) · Failed: Dissolution · RDTL Guwahati
31. UttarakhandZinc Sulphate 20mg Dispersible Tablets IP · batch T-15192Karnal Pharmaceuticals Pvt Ltd (248011) · Failed: NOT OF STANDARD QUALITY The sample Zinc Sulphate 20 mg Dispersible Tablets IP does not comply disintegration test as per I.P 2022. · State Lab Drugs Control Laboratory, Telangana.
32. KeralaCefixime Oral Suspension IP 100 mg/5ml · batch D2852/2 4-25Kerala Medical Services Corporation · Failed: It fails the test ?Assay? and ?Descriptive part? for oral powders specified above as per IP · DTL Thiruvananthapuram
33. KeralaClopidogrel Tab IP 75 mg · batch D 2720/24 -25Kerala Medical Services Corporation · Failed: It fails the test ?Dissolution?, ?Assay? and descriptive part for tablets specified above as per IP · DTL Thiruvananthapuram
34. KeralaVitamin B Complex Tablets N.F.I · batch S0018/2 4-25Kerala Medical Services Corporation · Failed: The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the laboratory protocol. · DTL Thiruvananthapuram
35. KeralaVitamin B Complex Tablets N.F.I · batch S0017/2 4-25Kerala Medical Services Corporation · Failed: The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the laboratory protocol. · DTL Thiruvananthapuram
36. GujaratSucralfate USP · batch LSU2409105LEGEND INDUSTRIES, Unit-II, Plot No. C1/200-201/4, Phase-II, Opp. Encore Ltd (382330) · Failed: Spurious Identification and Assay of Sucralfate · CDL Kolkata
37. HaryanaPara 500 · batch NBRT- 018Laborate Pharmaceuticals India Ltd (132046) · Failed: The sample does not conforms to the IP 2022 requirement w.r.t dissolution test · DTL Srinagar (J&K)
38. Himachal PradeshAmrox-LS syrup Levosalbutamol Sulphate, Amborxol Hydrochloride & Guaipenesin syrup · batch AJLH24 051Leeford Healthcare Ltd (173205) · Failed: MISBRANDED DRUG In the composition the label should be mentioned as Levosalbutamol Sulphate IP equivalent to Levosalbutamol. But the label is mentioned as only Levosalbutamol Sulphate IP, equivalent to Levosalbutamol as not mentioned. Hence it is a Misbranded drug as per section 17 of Drugs and Cosmetics Act, as it is not labeled in the prescribed manner. · State Lab Drugs Control Laboratory, Telangana.
39. State not givenDiclofenac Sodium tablets IP 50mg. · batch DT23- 38Leostar Healthcare Pvt. Ltd (502281) · Failed: NOT OF STANDARD QUALITY 1. While opening the strip, it is found that the tablets are not in intact condition. Hence sample is of Not of Standard Quality with respect to Description test parameter. 2. Disintegration test does not complies since the tablets disintegrated in acid medium completely. But as per IP the coating of the enteric coated should be in intact condition in acid medium. Hence sample is of Not of Standerd Quality with respect to Disintegration test parameter. · State Lab Drugs Control Laboratory, Telangana.
40. UttarakhandAlbendazole Tablets IP 400 mg · batch LMT241138Life Max Cancer Laboratories (249403) · Failed: "Dissolution" of Albendazole · RDTL Guwahati
41. Himachal PradeshGlitel M1 (Glimepride & Metformin Hydrochloride Prolonged Releasre Tablets IP) · batch LGN05/ 186/08Logos Pharma (174101) · Failed: The sample does not conform to Standard in respect of the tests for ?Assay, Dissolution & Uniformity of content for Glimepiride? performed. · SDTL Agartala, Tripura
42. Himachal PradeshGlitel M2 (Glimepride & Metformin Hydrochloride Prolonged Releasre Tablets IP) · batch LGM09/ 237/11Logos Pharma (174101) · Failed: The sample does not conform to Standard in respect of the tests for ?Assay, Dissolution & Uniformity of content for Glimepiride? performed. · SDTL Agartala, Tripura
43. Himachal PradeshPolywin Vitamin B Complex Injection (Polywin) · batch MA24H16MARTIN & BROWN BIO- SCIENCES PVT. LTD (173205) · Failed: Extractable volume, Particulate matter, Assay of Riboflavin Sodium Phosphate and Description · CDL Kolkata
44. Himachal PradeshRabeprazole Sodium Injection IP · batch MD24E30MARTIN & BROWN BIO- SCIENCES PVT. LTD (173205) · Failed: pH, Clarity of Solution, Particulate matter and Description · CDL Kolkata
45. Tamil NaduCEFIXIME & LACTIC ACID BACILLUS TABLETS (AFIX- L 200) · batch MDP - 785MEDINOK HEALTHCARE PVT. LTD (605009) · Failed: For the received sample Cefixime & Lactic Acid Bacillus tablets (AFIX- L 200), (i) The label on the secondary packaging, name of the colour information is concealed ,whereas the primary packaging label specifies 'Red oxide of Iron' as the colour. This discrepancy indicates a mismatch between the primary and secondary packaging labels. (ii) The primary packaging label claims the tablet colour is ' Red oxide of Iron' but physical verification of the tablet observed as pale yellow colour. - NSQ · Puducherry
46. Tamil NaduPREGABALIN AND METHYLCOBALA MIN CAPSULES (Amalin Plus ) · batch MDP- 774MEDINOK HEALTHCARE PVT. LTD (605009) · Failed: The sample received is labelled as PREGABALIN AND METHYLCOBALAMIN CAPSULES, however PREGABALIN AND METHYLCOBALAMIN CAPSULES is an official IP monograph (2022) hence should be labelled as PREGABALIN AND METHYLCOBALAMIN CAPSULES IP- Misbranded · Puducherry
47. State not givenAceclofenac, Paracetamol & Serratiopeptidase Tablets (Acemarc-SP Tablets) · batch MT-306Maha Avtar, Health Care Pvt. Ltd (201002) · Failed: Uniformity of weight · RDTL Chandigarh
48. Himachal PradeshRabeprazole Sodium Injection IP · batch MD23H10Martin & Brown Bio- Sciences K. No (173205) · Failed: pH, Clarity of Solution, Particulate matter, Related Substances and Assay of Rabeprazole sodium · CDL Kolkata
49. Himachal PradeshCarboxymethylcellulose Sodium Eye Drops IP 10 ml · batch MO24H19Martin & Brown Bio- Sciences Pvt. Ltd (173205) · Failed: pH and Sterility · CDL Kolkata
50. Himachal PradeshRabeprazole Tablets IP 20 mg · batch MT-24E30Martin & Brown Bio- Sciences Pvt. Ltd (173205) · Failed: Related Substances, Dissolution (Buffer Stage) and Assay of Rabeprazole Sodium · CDL Kolkata
51. Himachal PradeshAminophylline Injection I.P .10 ml · batch MA23L108Martin and Brown Biosciences K.No-918/419 (173205) · Failed: Particulate matter, Assay of Ethylenediamine and Theophylline and Description · CDL Kolkata
52. State not givenSitagliptin Phoshpate Tablets I.P. (50 mg) · batch MT243714Mascot Health Series Pvt. Ltd (249403) · Failed: Assay of Sitagliptin Phosphate · CDL Kolkata
53. KarnatakaLiquid Paraffin IP · batch 163Medi smith Pharma Lab (560074) · Failed: It fails the test ?Light Absorption? specified in the laboratory protocol as per IP · DTL Thiruvananthapuram
54. Tamil NaduPANTOPROZOL E SODIUM (EC) & DOMPERIDONE (SR) CAPSULES (Tonixpro DSR) · batch MDP- 345Medinok Healthcare Pvt. Ltd (605009) · Failed: 1. The primary packaging label claims 'Each film coated tablet contains:' however, on physical observation the received sample is found to be 'Hard Gelatin Capsules'. 2.The received sample is labelled as 'PANTOPROZOLE SODIUM (EC) & DOMPERIDONE (SR) CAPSULES', however Pantoprazole Gastro- resistant and Domperidone Prolonged-release Capsules is an official IP monograph (2022) hence should be labelled as PANTOPRAZOLE SODIUM (EC) & DOMPERIDONE (SR) CAPSULES IP. 3.The sample name and the label claim of the drug states 'PANTOPROZOLE' instead of 'PANTOPRAZOLE' but the proper name of the drug should be written asprescribed under 96(1), (i)(A) of the Drugs & Cosmetics Act.- Misbranded · Puducherry
55. State not givenAcetazolamide Tablets IP 250 mg · batch T 240840Micron Pharmaceuticals (396195) · Failed: It fails the test ?Dissolution? Specified in the laboratory protocol as per IP · DTL Thiruvananthapuram
56. State not givenVitamin B Complex Tablets N.F.I · batch VBT 2468Modern Laboratories (452015) · Failed: The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the laboratory protocol. · DTL Thiruvananthapuram
57. State not givenVitamin B Complex Tablets N.F.I · batch VBT 2415Modern Laboratories (452015) · Failed: The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the laboratory protocol. · DTL Thiruvananthapuram
58. State not givenVitamin B Complex Tablets N.F.I · batch VBT 2417Modern Laboratories (452015) · Failed: The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the laboratory protocol. · DTL Thiruvananthapuram
59. State not givenVitamin B Complex Tablets N.F.I · batch VBT 2414Modern Laboratories (452015) · Failed: The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the laboratory protocol. · DTL Thiruvananthapuram
60. State not givenVitamin B Complex Tablets N.F.I · batch VBT241 6Modern Laboratories (452015) · Failed: The sample does not conform to IP standards to Descriptive part for tablets As per IP, the tablets should have sufficient hardness to withstand handling without crumbling or breaking. The tablets are soft and in powdered form and cannot be removed from strip in intact form and further tests cannot be performed for the reason specified in the laboratory protocol. · DTL Thiruvananthapuram
61. PunjabCloprostenol Injection IP (Vet) (M Promate Injection) · batch I241020Monatt Biotech (151005) · Failed: Sheep Husbandry Supply / The sample is found spurious as the Assay contents of Cloprostenol Sodium I.P is found to be Nil and also fails in the Test for Sterility · DTL Srinagar (J&K) & MDTL Kathua (J&K)
62. AssamSodium Hypochlorite 5% (NaOCL) · batch NSSH1 0Neucleus Scientific (781017) · Failed: The Sample does not conform to standard in respect of the test ?Assay? performed. · SDTL Agartala, Tripura
63. UttarakhandCo-trimoxazole Tablets I.P. (D.S.= Double Strength) · batch PT30119OMEGA PHARMA (247667) · Failed: Dissolution (Sulphamethoxazol e and Trimethoprim) · RDTL Guwahati
64. Himachal PradeshTelmisartan Tablets IP (TELMOPI-40 Tablets) · batch 23I-T2013Orison Pharma International (173030) · Failed: Dissolution · RDTL Guwahati
65. PunjabURINIF-SR (Nitrofurantoin Sustained Release Tablets I.P. 100 mg · batch USR- 186Overseas Health Care Pvt. Ltd (144410) · Failed: The sample does not conform to standard in respect of the test for ?Dissolution? test performed. · SDTL Agartala, Tripura
66. PunjabAzithromycin Oral Suspension I.P. (Azysafe Liquid-100 ) · batch AZ1-206Overseas Healthcare Pvt. Ltd (144410) · Failed: Uniformity of Volume · CDL Kolkata
67. West BengalCOMPOUND SODIUM LACTATE INJECTION IP 500 ml. (Ringers Lactate I.P. ) (RL) · batch 03BF2442Paschim Banga Pharmaceuticals (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Bacterial endotoxins · CDL Kolkata
68. West BengalCiprofloxacin Injection IP (0.2%w/v) · batch 09AF0075Paschim Banga Pharmaceuticals (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Particulate contamination · CDL Kolkata
69. Himachal PradeshIsosorbide Dinitrate Tablets IP [ISOMIC 10] · batch PT- 42968Pharmaroots Healthcare · Failed: The sample does not conform to identification test for Isosorbide Dinitrate as per IP. Hence the sample is spurious and declared as Not of Standard Quality · DTL Thiruvananthapuram
70. Himachal PradeshTelmisartan Tablets IP 40mg (Savtel 40 Tablets) · batch PT-40584Pharmaroots Healthcare · Failed: Dissolution · RDTL Guwahati
71. Himachal PradeshAmoxyheal-CV tablets Amoxycillin & Potassium Clavulanate Tablets I.P · batch TB2403 78APolestar power industries(Pharma division) Damuwala (174103) · Failed: NOT OF STANDARD QUALITY The sample failed with respect to the test for Unifarmity of Weight for tablets, as 6 out of twenty tablets fall outside the prescribed limit of 5 percent. · State Lab Drugs Control Laboratory, Telangana.
72. Himachal PradeshPhenytoin Sodium Injection USP · batch PTS-225APushkar Pharma (173030) · Failed: Alcohol Content and Propylene Glycol content · CDL Kolkata
73. Tamil NaduTelmisartan Tab IP 40 mg [Telmasil-40] · batch TBS 034RTN Pharma (635109) · Failed: It fails the test ?Dissolution? Specified in the laboratory protocol as per IP · DTL Thiruvananthapuram
74. Himachal PradeshTELMISARTAN & HYDROCHLORO THIAZIDE TABLETS IP (Lanztel-H) · batch RHT24- 401Revantis Healthcare (173205) · Failed: For the received sample Telmisartan & Hydrochlorothiazide Tablets IP, Presence of Spot and Rough Surface was observed which should not be present as per Drugs & Cosmetics (Amendment) Act, 2008 of DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No. (i) Presence of Spot/discoloration (vii) Rough surface and rule 124B of the Drugs Rules,1945. -NSQ · Puducherry
75. Tamil NaduACECLOFENAC & PARACETAMOL TABLETS (ACPON-P) · batch ACP- 046Rippon Laboratories No.44-45 (605110) · Failed: The sample received is labelled as ACECLOFENAC & PARACETAMOL TABLETS (ACPON-P), however ACECLOFENAC & PARACETAMOL TABLETS is an official IP monograph (Addendum 2024) hence should be labelled as ACECLOFENAC & PARACETAMOL TABLETS IP.- Misbranded · Puducherry
76. UttarakhandSodium Bicarbonate Tablets U.S.P. 1000 mg (NABOSIS 1000 mg · batch T-2307270Rivpra Formulation Pvt. Ltd (249403) · Failed: Description · CDTL Hyderabad
77. Himachal PradeshHaloperidol Injection IP (Radipace) · batch L2403/2SBS Biotech · Failed: Particulate matter and Description · CDL Kolkata
78. PunjabPIOGLITAZONE 15, GLIMEPIRIDE 2mg+ METFORMIN 500 mg (Lanzpride- PM2) · batch SP/T/74 3SIGNORET PHARMACEUTICALS PVT.LTD (160059) · Failed: For the received sample PIOGLITAZONE 15, GLIMEPIRIDE 2mg+ METFORMIN 500 mg (Lanzpride-PM2), 1. The label is mentioned as ?Approved colour used? but common name of the permitted colour used in the formulation as prescribed under rule 127(2) of the Drugs Rules,1945 was not mentioned. 2.For the received sample PIOGLITAZONE 15, GLIMEPIRIDE 2mg+ METFORMIN 500 mg (Lanzpride-PM2), On visual inspection pink coloured spots were observed on other side (white colour) of the tablets .-Misbranded · Puducherry
79. PunjabSITAGLIPTIN PHOSPHATE 50 + METFORMIN 500MG TABLETS (LanZsita-M) · batch SP/T/76 1SIGNORET PHARMACEUTICALS PVT.LTD (160059) · Failed: For the received sample SITAGLIPTIN PHOSPHATE 50 + METFORMIN 500MG TABLETS (LanZsita-M), The label is mentioned as ?Approved colour used? but common name of the permitted colour used in the formulation as prescribed under rule 127(2) of the Drugs Rules,1945 was not mentioned.-Misbranded · Puducherry
80. Himachal PradeshFevanex Rapid - 650[ Paracetamol Tab IP 650 mg] · batch SRGT- 24471SPAS REMEDISE (173205) · Failed: It fails the test ?Dissolution? Specified in the laboratory protocol as per IP · DTL Thiruvananthapuram
81. TelanganaIron Sucrose Injection USP 100 mg/ 5 ml · batch 23IS10Sai Parenterals Limited (500055) · Failed: "pH", "Alkalinity" and "Particulate Matter In Injection" · CDTL Mumbai
82. Tamil NaduTELMISARTAN TABLETS IP 40 mg (Leaftel-40) · batch 240390Sai sarvaa Biotech Pvt. Ltd (605101) · Failed: Sheep Husbandry Supply / The sample is found spurious as the Assay contents of Cloprostenol Sodium I.P is found to be Nil and also fails in the Test for Sterility · Puducherry
83. State not givenAmrutharishtam · batch 58Sakthi Ayurveda Pharmaceuticals · Failed: It fails the test ?Total Solids? , ?Specific Gravity?, ?Reducing Sugar? and ?Alcohol Content? as specified in the Laboratory protocol as per API · DTL Thiruvananthapuram
84. State not givenAsokarishtam · batch 56Sakthi Ayurveda Pharmaceuticals · Failed: It fails the test ?Total Solids? , ?Specific Gravity?, ?Reducing Sugar? and ?Alcohol Content? as specified in the Laboratory protocol as per API · DTL Thiruvananthapuram
85. State not givenBalarishtam · batch 57Sakthi Ayurveda Pharmaceuticals · Failed: It fails the test ?Total Solids? , ?Specific Gravity?, ?Reducing Sugar? and ?Alcohol Content? as specified in the Laboratory protocol as per API · DTL Thiruvananthapuram
86. PunjabRABEPRAZOLE ENTERIC COATED TABLETS IP 20mg (Rabelanz-20) · batch SP/T/76 2Signoret Pharmaceuticals Pvt.Ltd (160059) · Failed: For the received sample Rabeprazole Enteric Coated Tablets IP 20mg, 1. Chipping and Rough surface defect was observed which should not be present as per Drugs & Cosmetics (Amendment) Act, 2008 of DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No. (V) Chipping and (Vii) Rough surface. 2. Cracking of the coating defect was observed which should not be present as prescribed under rule 124B of the Drugs Rules ,1945. 3. The label is mentioned as ?Approved colour used? but common name of the permitted colour used in the formulation as prescribed under rule 127(2) of the Drugs Rules ,1945 was not mentioned. 4. Does not comply with respect to test for Disintegration and Assay - NSQ · Puducherry
87. PunjabSITAGLIPTIN IP 100mg TABLETS (LanZsita 100) · batch SP/T/83 8Signoret Pharmaceuticals Pvt.Ltd (160059) · Failed: For the received sample Sitagliptin IP 100mg Tablets (LanZsita 100), The label is mentioned as ?Approved colour used? but common name of the permitted colour used in the formulation as prescribed under rule 127(2) of the Drugs Rules ,1945 was not mentioned.- Misbranded · Puducherry
88. Himachal PradeshXorcid-O Suspension · batch LSF- B0656Spen Formulations Pvt Ltd (174315) · Failed: Under Investigation / The sample is found spurious as the Assay contents of Sucralfate and Oxetacaine are found to be NIL and also fails in the test for Description · DTL Srinagar (J&K) & MDTL Kathua (J&K)
89. Tamil NaduCALCIUM WITH VITAMIN D3 TABLETS IP (S- CAL) · batch ST2406 09Spycaa Life care Sciences Private Limited (603308) · Failed: For the received sample, label is mentioned as "Approved colour used" but common name of the permitted colour used in the formulation as prescribed under rule 127(2) of the Drug Rule,1945 was not mentioned.-Misbranded · Puducherry
90. West BengalAmoxycillin & Potassium Clavulanate Tab I.P. · batch APTD- 002Standard Pharmaceuticals Ltd (712203) · Failed: Does not conform to I.P. · SDTL Kolkata
91. TelanganaCefixime Dispersible Tablets IP 100 mg · batch oo84Stride Organics Private Limited · Failed: MISBRANDED DRUG 1. The sample is deemed to be misbranded as it is labeled only with the words approved colours used but fails to include the common name of the color on the label, as required by Rule 127(2) of the Drugs Rules, 1945. 2. Additionally, the label does not state that the tablets should be dispersed in water immediately before use, as required by the IP 2022 monograph for Cefixime Dispersible tablets. Hence, the drug is deemed Misbranded under section 17 of the Drug and Cosmetics Act, 1940 as it is not labeled in the prescribed manner. · State Lab Drugs Control Laboratory, Telangana.
92. Himachal PradeshFerric Carboxymaltose Injection 1 g,/ 20 ml (For IV Injection / Infusion) · batch SVI-24168BSunvet Healthcare (173001) · Failed: "Bacterial Endotoxins", "Sterility" and "Assay" · CDTL Mumbai
93. Himachal PradeshFerric Carboxymaltose Injection 500 mg/ 10 ml (For IV Injection / Infusion) · batch SVI-24171ASunvet Healthcare (173001) · Failed: "Bacterial Endotoxins", "Sterility" and "Assay" · CDTL Mumbai
94. Himachal PradeshMETHYLCOBALA MIN, FOLIC ACID, ALPHA LIPOIC ACID, VITAMIN B6, CHROMIUM PICOLINATE, SODIUM SELENITE & ZINC SOFT GELATIN CAPSULES (Mi- 6) · batch SOD- 2470Symbiosis Pharmaceuticals Pvt. Ltd (173030) · Failed: Does not comply with respect to test for Disintegration -NSQ · Puducherry
95. Madhya PradeshDrotaverine Hydrochloride Tablets 40 mg. (Dratovis-40 ) · batch 12680Syncom Formulations (India) Ltd (454775) · Failed: Assay of Drotaverine Hydrochloride · CDL Kolkata
96. MaharashtraMIDAZOLAM Injection IP · batch 24257T Walkers Pharmaceuticals Pvt Ltd (411004) · Failed: NOT OF STANDARD QUALITY The sample Midazolam Injection I.P does not comply for Assay and pH parameters as per IP 2022. · State Lab Drugs Control Laboratory, Telangana.
97. OdishaDisinfectant Fluid Phenolic Type (Konark Super Phenyle) · batch KSP-355Teedeecol (India) (768201) · Failed: Grade and Germicidal Value · CDL Kolkata
98. Himachal PradeshLevosalbutamol Sulphate, Ambroxol Hydrochloride & Guaiphenesin Syrup, (Blurex-LS Syrup) · batch TBHX0448Three B Healthcare Ltd (173025) · Failed: Assay of Ambroxol Hydrochloride · CDL Kolkata
99. Himachal PradeshLinezolid Tablets I.P. 600 mg. (ALINO-600 Tablets) · batch VLB-GT-2500Vee Laboratories (173211) · Failed: Dissolution · RDTL Guwahati
100. Himachal PradeshNorfloxacin Tablets I.P. 400mg. · batch NFXT-1002WINGS BIOTECH LLP (173205) · Failed: Dissolution · RDTL Guwahati
101. Himachal PradeshDICLOFENAC SODIUM AND PARACETAMOL TABLETS I.P (DiCLOWiN PLUS) · batch DPT- 5765Wings Biotech LLP (173205) · Failed: Does not comply with respect to Assay for Diclofenac sodium -NSQ · Puducherry
102. Himachal PradeshAmoxycillin & Clavulanate Potassium for Oral Suspension I.P. 3.6gm/30ml · batch 724-37ZEE LABORATORIES LTD (173025) · Failed: Identification and Assay/Content of Clavulanic Acid · RDTL Guwahati
103. Himachal PradeshParacetamol Tab IP [Parayes -500 ) · batch 423- 1582Zee Laboratories Ltd (173025) · Failed: It fails the test ?Dissolution? Specified in the laboratory protocol as per IP · DTL Thiruvananthapuram