October 2024.91 failed batches.

Batches, by manufacturer

1. Madhya PradeshOndansetron Injection IP 2mg/ml · batch OT-5411Alchemist Remedies Pvt. Ltd · Failed: The sample does not Conform to IP Standards with respect to TEST FOR STERILITY · CDTL Chennai
2. TelanganaFer-XT Tablets, Ferrous Ascorbate & Folic Acid Tablets · batch FXT.2309Alfansa Bio Pvt.Ltd (500072) · Failed: NOT OF STANDARD QUALITY & MISBRANDED The drug product ferrous Ascorbate and Folic Acid Tables is official in Indian Pharamacopoeia 2022. But the letters IP is not mentioned on the strip after the product name Ferrous Ascorbate and Folic Acid tablets. Hence it is a Misbranded Drug under section 17 of Drugs and Cosmetics Act 1940. So the drug product Ferrous Ascorbate & Folic Acid Tablets is Not of Standard Quality and Misbranded. · State Lab Drugs Control Laboratory, Telangana.
3. Himachal PradeshAceclofenac & Paracetamol Tablets (Eldigesic-P) · batch AGT305144Alventa Pharma Limited (174101) · Failed: Assay of Aceclofenac · CDTL Mumbai
4. Himachal PradeshElcipro 500[Ciprofloxacin Hydrochloride Tab IP 500 mg ] · batch AGT31256Alventa Pharma Ltd (174101) · Failed: It fails the test ?Dissolution? as per IP as specified in the Laboratory Protocol · DTL Thiruvananthapuram
5. UttarakhandRacecadotril & Oflozacin Suspension (Combact-O + Suspension) · batch L23J003ABajaj Formulations (247661) · Failed: Assay of Racecadotril & Ofloxacin · CDTL Mumbai
6. MaharashtraPropylene Glycol USP / IP · batch BT1205B251 22023Balaji Amines Limited (413255) · Failed: Water · CDTL Mumbai
7. GujaratSodium Fusidate Cream 2 % · batch 344Bharat Parenterals Limited (391250) · Failed: Assay · CDTL Mumbai
8. State not givenParacetamol Tablets IP 500 mg (Pararex-500 · batch CT-7129CHEMETAC PHARMACEUTICALS (201003) · Failed: Dissolution · RDTL Guwahati
9. Himachal PradeshBETAHISTINE DIHYDROCHLO RIDE TABLETS IP(CGHEST-8) · batch CT2425028 4BCMG BIOTECH 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
10. Himachal PradeshCiprofloxcin Tablets IP 250 mg · batch CT23241818CMG BIOTECH PVT.LTD (176501) · Failed: Dissolution of Ciprofloxcin · RDTL Guwahati
11. Himachal PradeshTrypsin & Chymotrypsin Tablets (Lysoflam Forte) · batch LFTF24002CCachet Pharmaceuticals Private Limited (173205) · Failed: Assay of Trypsin & Chymotrypsin · CDL Kolkata
12. Himachal PradeshRabeprazole Sodium (EC) and Levosulpiride (SR) Capsules (RPL LS CAPSULES) · batch CGC-24020Calrax Healthcare Pvt.Ltd (173205) · Failed: Dissolution of Levosulpiride · RDTL Chandigarh
13. Himachal PradeshVRIZAROX-100DT Tablets Cefpodoxime Proxetil Dispersible Tablets · batch CABQ4001Chiros Pharma (173211) · Failed: MISBRANDED The monograph of Cefpodoxime Tablets in the current edition of Indian Pharamacopoeia i.e. IP-2022. is also applicable for Cefpodoxime Dispersible Tablets as indicated under labelling section of the monograph. However the firm failed to indicate the latters IP after the product name CefpodoximeDispersible Tablets. Hence, the drug is deemed to be Misbranded as per section 17 of the Drugs and Cosmetics Act, 1940, since it is not labeled in the prescribed mannar. · State Lab Drugs Control Laboratory, Telangana.
14. UttarakhandC Mont LC KID 60 ml[Montelukast and Levocetirizine Dihydrochloride syrup 60 ml ] · batch AL 23206Cian Healthcare Ltd (247661) · Failed: The content of Montelukast sodium is not with in the limits of ?Schedule V? of Drugs and Cosmetics Act & Rules thereunder as specified in the Laboratory Protocol · DTL Thiruvananthapuram
15. Himachal PradeshTelmisartan Tablets I.P. (Telesky-40 Tablet) · batch CMT23-1658Cortex Medical Inc · Failed: Dissolution · RDTL Guwahati
16. PunjabPaclitaxel Injection IP · batch OI220089ACosmas Research Lab Ltd (141008) · Failed: Description & Particulate Matter · CDL Kolkata
17. Himachal PradeshCefem -200 Tablets, Cefixime with Lactic Acid Bacillus tablets · batch DB240126Daxin Pharmaceuticals Pvt Ltd (174103) · Failed: NOT OF STANDARD QUALITY 1. Thirteen Individual weights deviated from the average weight 636.0 mg i.e 6 tablets deviated by less than 5 percent and 7 tablets deviated by more than 5 percent . Hence the sample does not complies the test Uniformity of weight. 2. Assay of Cefixime does not complies. Hence the sample is of NOT OF STANDARD QUALITY · State Lab Drugs Control Laboratory, Telangana.
18. State not givenDecitabine for Injection 50 mg / vial · batch H230266Dr. Reddys Laboratories · Failed: Water Content · CDL Kolkata
19. Himachal PradeshBetamethasone Sodium Phosphate Injection I.P. (Betalone ) · batch IBT-11189E.G. Pharmaceuticals · Failed: Description & Particulate matter · CDL Kolkata
20. KeralaInternational dona Beauty Soap Jasmine · batch DNJN1/24Excel+ Health care products (695143) · Failed: The sample does not conform to IS 2888:2004 for the test ?matter insoluble in alcohol , percent by Mass, Max ? as per the specifications of toilet soap for Grade III · DTL Thiruvananthapuram
21. Himachal PradeshAmoxycillin and Potassium Clavulanate Injection (Manclav 300 mg) · batch HIAP23001AHealth Biotech Ltd (173205) · Failed: Particulate matter and Assay of Potassium Clavulanate calculated as Clavulanic Acid · RDTL Chandigarh
22. State not givenPanlib -D [Pantoprazole and Domeperidone Tablets] · batch HTN253DHimalaya Meditek pvt.Ltd (248197) · Failed: It fails the test ?Disintegration? as per IP and the contents of active ingredients of Pantoprazole and Domeperidone are not with in the limits of ?Schedule V? of Drugs and Cosmetics Act & Rules thereunder as specified in the Laboratory Protocol · DTL Thiruvananthapuram
23. HaryanaOrnidazole & Ofloxacin Tablets IP · batch HOOA07Hindustan Antibiotics Ltd (121001) · Failed: Description · CDL Kolkata
24. TelanganaZyfer-XT Tablets, Ferrous Ascorbate, Folic Acid Tablets · batch WW-2405Hindustan Nutraceuticals INC · Failed: NOT OF STANDARD QUALITY Sample Does not meets the Specifications wrt. Assay of Folic Acid as per STP. · State Lab Drugs Control Laboratory, Telangana.
25. SikkimAmlodipine and Perindopril Tablets (Amtas PRP) · batch K2201310Intas Pharmaceuticals Ltd (737132) · Failed: Assay of Perindopril Erbumine · CDL Kolkata
26. Himachal PradeshTorsemide Tablets IP (Torverge-10 Tablets) · batch GT7137AJ.M. Laboratories (173211) · Failed: Assay of Torsemide (86.85%) · RDTL Chandigarh
27. HaryanaAbsorbent Cotton Wool IP · batch 2013Jind Surgicals (126102) · Failed: Surface active Substances, Sulphated ash, Fluorescence, Water Soluble Substances · CDL Kolkata
28. KeralaTheophylline & Etophylline Tablets · batch TE4029Kerala State Drugs & Pharmaceuticals Ltd · Failed: It fails the test ?Disintegration? Specified in the Laboratory Protocol as per IP · DTL Thiruvananthapuram
29. TelanganaMyoplus Tablets, Paracetamol & Chlorzoxazone Tabletes · batch MT24-1LEOSTAR Healthcare Pvt.Ltd (502281) · Failed: NOT OF STANDARD QUALITY 18 Tablets were tested. All the 18 tablets did not Disintigrate within the time limit (i.e 15 Minutes) specified as per IP. · State Lab Drugs Control Laboratory, Telangana.
30. Himachal PradeshEnrofloxacin Injection I.P. (Vet.) (ENROXACIN VET Injection) · batch LV326Lavista Ideal Pharmacy Pvt. Ltd (173205) · Failed: pH · CDL Kolkata
31. GujaratSUCRALFATE USP · batch LSU2404015Legend Industries, (Unit-II) C1/200, 201/4, Phase-II, GIDC, Opp. Encore Ltd (382330) · Failed: Spurious, Identification & Assay · CDL Kolkata
32. UttarakhandCalcium 500 mg with Vitamin D3 250 IU Tablets IP · batch LMT240377Life Max Cancer Laboratories (249403) · Failed: Dissolution of Calcium and Assay of Vitamin D3 · RDTL Guwahati
33. UttarakhandGlimepiride Tablets IP 2 mg · batch LMT240333Life Max Cancer Laboratories (249403) · Failed: Dissolution · RDTL Guwahati
34. UttarakhandTelmisartan Tablets I.P. 40 mg · batch LMT240611Life Max Cancer Laboratories (249403) · Failed: Description · RDTL Guwahati
35. UttarakhandTelmisartan Tablets IP 40 mg · batch LMT240536Life Max Cancer Laboratories (249403) · Failed: Description · RDTL Guwahati
36. SikkimGlucosamine Sulfate Potassium Chloride MSM and Diacerein Tablets (Orcerin GM ) · batch KOO2207AMACLEODS PHARMACEUTICAL LTD (737135) · Failed: Description · CDL Kolkata
37. Himachal PradeshAceclofenac, Paracetamol and Serratiopeptidase Tablets (Megaceclo SP) · batch AMT2302037MARINE MEDICARE PVT. LTD (174103) · Failed: Description and Assay of Serratiopeptidase · CDL Kolkata
38. Himachal PradeshPantoprazole Tablets IP · batch MT-23J13MARTIN & BROWN BIO- SCIENCES PVT. LTD (173205) · Failed: Dissolution (Buffer Stage) · RDTL Chandigarh
39. Himachal PradeshIron Sucrose Injection USP 5 ml · batch MA24B129MARTIN & BROWN BIO-SCIENCES PVT. LTD (173205) · Failed: Particulate Matter · CDL Kolkata
40. Madhya PradeshDiclofenac Sodium, Paracetamol & Chlorzoxazone Tablets · batch DCPT3310MODERN LABORATORIES (452015) · Failed: Disintegration · CDL Kolkata
41. Himachal PradeshEMITIL [Prochlorperazine Mesylate Injection IP] · batch MA 24E27Martin & Brown Bio Science Pvt Ltd (173205) · Failed: It fails the test ?pH? as per IP as specified in the Laboratory Protocol · DTL Thiruvananthapuram
42. Himachal PradeshAmoxycillin and Potassium Clavulanate Tablets IP (Moxileb-CV 625 Tablets) · batch MBT23068Mediwell Biotech (173205) · Failed: Assay of Amoxycillin Trihydrate calculated as Amoxycillin · RDTL Chandigarh
43. Madhya PradeshItraconazole Capsules USP 100 mg · batch IZC2401Modern Laboratories (452015) · Failed: Dissolution · SDTL Agartala, Tripura
44. Madhya PradeshVitamin B Complex Tablets N.F.I · batch VBT2498Modern Laboratories (452015) · Failed: Description · SDTL Agartala, Tripura
45. Madhya PradeshVitamin B m plex Tablets N.F.I · batch VBT2442Modern Laboratories (452015) · Failed: Description · SDTL Agartala, Tripura
46. State not givenDulhan Special · batch NilMohsin Idustries · Failed: MISBRANDED · State Lab, Drugs Control
47. State not givenMontelukast Tablets IP 10 mg · batch F4E0425Morepan Laboratories Ltd · Failed: It fails the test ?Dissolution? Specified in the Laboratory Protocol as per IP · DTL Thiruvananthapuram
48. State not givenSingle use Syringe (EDGEX) · batch 5DSB27NOBLE PHARMACARE LTD (751024) · Failed: Cleanliness and Design of Piston/Plunger assembly · RDTL Chandigarh
49. Madhya PradeshIron Sucrose Injection USP 5 ml · batch IRA12320Nandani Medical Laboratories Pvt. Ltd · Failed: Specific Gravity, Particulate matter, Assay of Sucrose & Assay of Ferric Hydroxide with sucrose calculated as elemental Iron · CDL Kolkata
50. Himachal PradeshTerbinafine Hydrochloride Tablets IP (TERBONATE- 250) · batch NT-7900Neptune Life Sciences Pvt. Ltd (173205) · Failed: Test for Dissolution · CDTL Hyderabad
51. HaryanaTablets, Cefixime Tablets IP 400 mg · batch CTTB-01Nestor Pharmaceticals Limited (121001) · Failed: NOT OF STANDARD QUALITY Tablets does not complies in respect of Description. · State Lab Drugs Control Laboratory, Telangana.
52. HaryanaMeropenem Injection IP (ZENEM 1 g INJECTION) · batch B240720DOSCAR REMEDIES PVT.LTD (135001) · Failed: Particulate matter and Content of Sodium · RDTL Chandigarh
53. West BengalChlorhexidine Gluconate Solution 4% w/v · batch 12OVERSEAS CHEMICALS (712247) · Failed: Assay · CDL Kolkata
54. Himachal PradeshEnalapril Maleate Tablets IP 5 mg (Opioril- 5) · batch 23HT1771Orison Pharma International (173030) · Failed: Dissolution and Assay of Enalapril Maleate · CDTL Mumbai
55. HaryanaFexofenadine Hydrochloride Tablets I.P. · batch T-2403971Oscar Remedies Pvt. Ltd (135001) · Failed: Dissolution of Fexofenadine Hydrochloride. · RDTL Guwahati
56. GujaratSUCRALFATE USP · batch SCF/24/0049Par Drugs & Chemicals Limited (364004) · Failed: Spurious, Identification & Assay · CDL Kolkata
57. West BengalCiprofloxacin Injection IP 100 ml · batch 09AF0061Paschim Banga Pharmaceuticals (A Unit of Farista Vanijya Pvt. Ltd (733214) · Failed: Extractable Volume · CDL Kolkata
58. Himachal PradeshNatamycin Ophthalmic Suspension IP (Nataprime Eye Drops) · batch PE062308Primus Pharmaceuticals (173030) · Failed: Sterility · CDL Kolkata
59. Himachal PradeshAciclovir Intravenous Infusion IP 250 mg (Acyclotech Injection) · batch D0072406BProtech Telelinks (173030) · Failed: Assay of Aciclovir · RDTL Chandigarh
60. GujaratBupropion Hydrochloride Extended Release Tablets U.S.P. 150 mg (Brudel SR-150) · batch T23169Rebase Lifescience Pvt. Ltd (382430) · Failed: Assay of Bupropion Hydrochloride · CDTL Mumbai
61. UttarakhandCiprofloxacin Tablets U.S.P. 500 mg · batch T-2401066Rivpra Formulation Pvt. Ltd (249403) · Failed: Dissolution · RDTL Guwahati
62. RajasthanBuprenorphine Injection I.P. (LUPIGESIC) · batch 1470 ASGS.M.G. PHARMACEUTICALS (Pvt) Ltd (306185) · Failed: Assay" of Buprenorphine · RDTL Guwahati
63. TelanganaAmoxycillin and Potassium Clavulanate for Injection IP 1.2 gm · batch 23AP10SAI Parenterals Limited (500055) · Failed: Particulate matter & Clarity of Solution · CDL Kolkata
64. UttarakhandMetronidazole 400 mg Tablets (Metagyl - 400) · batch B22-275Saint Michael Biotech (247656) · Failed: Dissolution of Metronidazole. · RDTL Guwahati
65. MaharashtraTrenaxa Inj. [Tranexamic Acid injection I.P] · batch TNA2407Sanjivani Paranteral Ltd (400701) · Failed: It fails the test Sterility as per IP · DTL Thiruvananthapuram
66. Himachal PradeshAdrenaline Injection IP 1.8mg/ml (Adrenascot) · batch GA3A020Scott-Edil Pharmacia Ltd (173205) · Failed: Appearance of Solution and Description · RDTL Guwahati
67. Himachal PradeshRabeprazole Sodium & Domperidone SR Capsules (RABALKEM- DSR) · batch RKBC22064 SShiva Biogenetic Laboratories Pvt. Ltd (174101) · Failed: Assay of Rabeprazole · CDL Kolkata
68. GujaratBiocetamol -500 · batch SPD230078Skymap Pharmaceuticals Pvt. Ltd (382110) · Failed: The sample does not conform to the IP requirements with respect to the test, 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)
69. GujaratPantoprazole Sodium (Enteric Coated and Domperidone (Sustained Release) Capsules (Penstal-DSR) · batch C582Stalion Laboratories Pvt. Ltd (382220) · Failed: Dissolution of Domperidone · CDTL Mumbai
70. Himachal Pradesh(COUGH-DM Cough Syrup) · batch SHL3037Sunfine Healthcare · Failed: Assay of Phenylephrine Hydrochloride · RDTL Chandigarh
71. KeralaTelmisartan Tab IP 40 mg · batch S0007/24- 25Supplied by Kerala Medical Services Corporation · Failed: It fails the test ?Dissolution? as per IP · DTL Thiruvananthapuram
72. KeralaVitamin B Complex Tablet · batch S0010/24- 25Supplied by Kerala Medical Services Corporation · Failed: The sample does not conform to IP Standards with respect to ?Descriptive part? for tablets · DTL Thiruvananthapuram
73. KeralaVitamin B Complex Tablet · batch S0008/24- 25Supplied by Kerala Medical Services Corporation · Failed: The sample does not conform to IP Standards with respect to ?Descriptive part? for tablets · DTL Thiruvananthapuram
74. KeralaVitamin B Complex Tablet · batch S0009/24- 25Supplied by Kerala Medical Services Corporation · Failed: The sample does not conform to IP Standards with respect to ?Descriptive part? for tablets · DTL Thiruvananthapuram
75. Himachal PradeshEsomeprazole Tablets IP 40 mg (Essokynt-40) · batch TT23-505Tanishka Pharmaceuticals Pvt. Ltd · Failed: Dissolution (Buffer Stage) · RDTL Guwahati
76. Himachal PradeshTablets, Divalproex Sodium SR Tablets 500 mg · batch TMT-0211Tas Med (Indi) Pvt. Ltd (173205) · Failed: MISBRANDED The drug product Divalproex Sodium SR Tablets is official in the currect edition of IP 2022. and as required as per second schedule 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 conjunctin with the official title Divalproex Sodium SR Tablets on the label of the drug product was not mentioned as an indication that the drug product purports to comply with IP standrds. Hence the drug product shall be deemed to be MISBRANDED DRUG as per Section 17 of the drug and Cosmetics Act 1940 as it not labeled in the prescribed manner · State Lab Drugs Control Laboratory, Telangana.
77. Himachal PradeshDivalproex Sodium SR Tablets · batch TMT-0165Tas Med (India) Pvt.ltd (173205) · Failed: MISBRANDED The drug product Divalproex Sodium SR Tablets is official in the currect edition of IP 2022. and as required as per second schedule of the Drugs and cosmetics Act, 1940, the said drug product shall comply with the standards set out in the · State Lab Drugs Control Laboratory, Telangana.
78. Himachal PradeshDivalproex Sodium SR Tablets 500 mg · batch TMT-0164Tas Med (India) Pvt.ltd (173205) · Failed: MISBRANDED The drug product Divalproex Sodium SR Tablets is official in the currect edition of IP 2022. and as required as per second schedule 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 conjunctin with the official title Divalproex Sodium SR Tablets on the label of the drug product was not mentioned as an indication that the drug product purports to comply with IP standrds. Hence the drug product shall be deemed to be MISBRANDED DRUG as per Section 17 of the drug and Cosmetics Act 1940 as it not labeled in the prescribed manner · State Lab Drugs Control Laboratory, Telangana.
79. Himachal Pradeshcefixime Dispersible Tablets IP 100mg · batch CT240783Theon Pharmaceuticals LTD (174101) · Failed: Assay & Disintegration · SDTL Agartala, Tripura
80. UttarakhandHydroquinone, Tretinoin & Allantoin Cream (Lumadip) · batch LD-18Tosc International Pvt. Ltd (263153) · Failed: Description & pH · CDL Kolkata
81. Himachal PradeshLiposomal Amphotericinn B Injection 50mg (Ambilip) · batch ALLC4A1UNITED BIOTECH (P) LIMITED (174101) · Failed: Bacterial endotoxins and Assay of Amphotericin B · CDL Kolkata
82. Himachal PradeshRabeprazole Sodium (Enteric Coated) And Domperidone (Sustained Release) Capsules (ZABIL- DSR) · batch UD2C- 23469EUltra Drugs Pvt. Ltd (173205) · Failed: Dissolution of Rabeprazole & Domperidone, Assay of Domperidone · CDL Kolkata
83. State not givenCefixime Tablets IP (TAXIM-O 200) · batch 23460072Under Investigation · Failed: Dissolution and Assay · Not applicable
84. State not givenPantoprazole Gastro-resistant and Domeperiodone Prolong Released Capsules IP ( PAN-D) · batch 23444296Under Investigation · Failed: Identification and Assay · Not applicable
85. State not givenRosuvastatin Tablets IP (Rosuvas 10) · batch SIE0116AUnder Investigation · Failed: Dissolution and Assay · Not applicable
86. UttarakhandParacetamol Tablets IP 650 mg [Nopain-650] · batch URDT2433Unicure India Ltd (247661) · Failed: It fails the test ?Dissolution? Specified in the Laboratory Protocol as per IP · DTL Thiruvananthapuram
87. Himachal PradeshAmpicillin 1G Powder for Injection 1000 mg · batch EXPN-24004Unital Formulations · Failed: Particulate matter and Assay of Ampicillin Sodium calculated as Ampicillin · RDTL Chandigarh
88. Himachal PradeshCeftriaxone and Sulbactam for Injection (Tykone- S Injection) · batch UNI-240013Unital Formulations · Failed: Particulate matter · RDTL Chandigarh
89. Himachal PradeshRosuvastatin Tablets IP (ROZUTIN- 10) · batch VDT-23531Vidhyasha Pharmaceuticals (173030) · Failed: Related Substances · CDL Kolkata
90. TelanganaCYPROHEPTAD INE HCl & TRICHOLINE CITRATE · batch WHL-00623Warner Hindusthan Pvt Ltd (500039) · Failed: The label of the container in the drug is mentioned as 'Approved colour used' but the common name of the · State Lab Puducherry
91. Himachal PradeshMontelukast Sodium and Levocetirizine Hydrochloride Tablets IP 10 mg/5 mg · batch MLHT-1022Wings Biotech LLP (173205) · Failed: It fails the test ?Dissolution? Specified in the Laboratory Protocol as per IP · DTL Thiruvananthapuram