CDSCO declared Not of Standards Drugs and Cosmetics July 2022

CDSCO declared Not of Standards Drugs and Cosmetics July 2022

List  of  Drugs,  Medical  Devices  and  Cosmetics  declared  as  Not  of  Standard Quality/Spurious/Adulterated/Misbranded for the Month of July – 2022.

Total number of samples tested1337
Total number of samples declared as of Standard Quality1283
Total number of samples declared as Not of Standard Quality53
Total number of samples declared as Spurious
Total number of samples declared as Misbranded1
S.No.Name of Drugs/medical device/cosmeticsBatch No./Date of Manufacture/Date of Expiry/Manufactured ByReason for failureDrawn ByFrom
1.Rabeprazole Gastro Resistant Tablets I.P. 20mgB. No.: RRZT-014 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Revat Laboratories Pvt. Ltd., 12-321, Opp. I.D.A. Kurnool Road, Pernamitta, Ongole- 523002, Andhra Pradesh.AssayDrug Control Department BiharRDTL Guwahati
2.Paracetamol Tablets IP 650mgB. No.: T-20159 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Parth Orgichem Pvt. Ltd. Plot No.G-365, M.G. Road, Industrial Area, Hapur, Uttar Pradesh.Assay & DissolutionDrug Control Department AssamRDTL Guwahati
3.Ofloxacin & Ornidazole Tablets IPB. No.: SCZAG21004 Mfg dt: 06/2021 Exp dt: 11/2023 Mfd by: M/s. Sano – Cito Therapeutics Inc. (A Meridian Group Co.) Village Lonaran, P.O. Ghatti, Solan-173211, Himachal Pradesh.DissolutionDrug Control Department AssamRDTL Guwahati
4.Rabeprazole Gastro Resistant Tablets IP 20mg.B. No.: RRZT-017 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Revat Laboratories Pvt. Ltd., 12-321, Opp. I.D.A., Kurnool Road,DescriptionDrug Control Department BiharRDTL Guwahati
  Pernamitta, Ongole- 523002, Andhra Pradesh.   
5.Levocetirizine Dihydrochloride Tablets IP 5 mgB. No.: LCL-2105 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Apple Formulation Pvt. Ltd., Plot No- 208, Kishanpur, Roorkee- 247667, Uttarakhand.DissolutionDrug Control Department AssamRDTL Guwahati
6.Rabeprazole Gastro Resistant Tablets IP 20mg.B. No.: RRZT-018 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Revat Laboratories Pvt. Ltd., 12-321, Opp. I.D.A., Kurnool Road, Pernamitta, Ongole- 523 002, Andhra Pradesh.DescriptionDrug Control Department BiharRDTL Guwahati
7.Rabeprazole Gastro Resistant Tablets IP 20mg.B. No.: RRZT-013 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Revat Laboratories Pvt. Ltd., 12-321, Opp. I.D.A., Kurnool Road, Pernamitta, Ongole- 523 002, Andhra Pradesh.DescriptionDrug Control Department BiharRDTL Guwahati
8.Rabeprazole Sodium(E.C.) & Itopride Hydrochloride Sustained Release CapsulesB. No.: AC-20107 Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: M/s. Accretion Pharmaceuticals, 29, Xcelon Indl Park-1, Vasna-Chacharwadi, Ahmedabad – 382213, Gujarat.AssayDrug Control Department AssamRDTL Guwahati
9.Ofloxacin & Ornidazole Tablets IPB. No.: TK0034A Mfg dt: 11/2020  Exp dt: 10/2022  Mfd by: M/s. Navkar Lifesciences, Plot No. 76, Lodhi Majra, Industrial Area, Baddi, Distt. Soaln, Himachal Pradesh.DissolutionCDSCO Sub- Zone GuwahatiRDTL Guwahati
10.Rabeprazole Sodium Tablets IP (Rabcia 20)B. No.: RIA-01 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Applied Communication & Controls, Khasra No. 122, Selaqui Industrial Area, Dehradun, Uttarakhand – 248 011.AssayDrug Control Department AssamRDTL Guwahati
11.Rabeprazole Gastro-Resistant Tablets IP (Wrabzole-20)B. No.: PNT2435B Mfg dt: 09/2020 Exp dt: 08/2022 Mfd by: M/s. Plena Remedies, Plot No. 17, Industrial Area (Himuda), Bhatoli Klan, Baddi, Distt. Solan, Himachal Pradesh.Assay & Related SubstancesDrug Control Department AssamRDTL Guwahati
12.Rabeprazole Gastro Resistant Tablets IP 20 mgB. No.: RRZT-015 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Revat Laboratories Pvt. Ltd. 12-321, Opp. I.D.A., Kurnool Road, Pernamitta, Ongole- 523002, Andhra Pradesh.Description & AssayDrug Control Department BiharRDTL Guwahati
13.Paracetamol Tablets IP 500 mg.B. No.: DT21-222 Mfg dt: 09/2021 Exp dt: 08/2023 Mfd by: M/s. Ornate Labs Pvt. Ltd. Bela Industrial Estate, Muzaffarpur-842005, Bihar.Dissolution & AssayDrug Control Department JharkhandRDTL Guwahati
14.Levocetirizine Dihydrochloride Tablets IP 5 mgB. No.: LCL-2105 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Apple Formulations Pvt. Ltd. Plot No. 208, Kishanpur, Roorkee- 247667, Uttarakhand.DissolutionDrug Control Department AssamRDTL Guwahati
15.Telmisartan Tablets IP 40 mgB. No.: TETY-01 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. NESTORDissolutionDrug Control Department JharkhandRDTL Guwahati
  PHARMACEUTICALS LIMITED, 11, Western Extension Area, Faridabad-121001, Haryana, INDIA.   
16.Ofloxacin & Ornidazole Tablets IPB. No.: PC21053 Mfg dt: 03/2021 Exp dt: 02/2023 Mfd by: M/s. Prochem Pharmaceuticals (P) Ltd. 140-141, Makkanpur, Bhagwanpur, Roorkee, Dist. Haridwar, Uttarakhand – 247661.DissolutionDrug Control Department AssamRDTL Guwahati
17.Ciprofloxacin Tablets I.P.B. No.: LCCT-001 Mfg dt: 05/2021 Exp dt: 04/2024 Mfd by: M/s. Laborate Pharmaceuticals India Ltd., (Unit-II) 31, Rajban Road, Nariwala, Paonta Sahib, Himachal Pradesh.DissolutionDrug Control Department AssamRDTL Guwahati
18.Rabeprazole Gastro-Resistant Tablets IPB. No.: PNT2435B Mfg dt: 09/2020 Exp dt: 08/2022 Mfd by: M/s. Plena Remedies, Plot No. 17, Industrial Area (Himuda), Bhatoli Kalan, Baddi, Distt. Soaln, Himachal Pradesh.Assay & DescriptionDrug Control Department AssamRDTL Guwahati
19.Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IPB. No.: 21112704 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Mercury Laboratories Limited, Unit No. 2, Halol – Baroda Road, Village : Jarod, Tal : Waghodia, Dist : Vadodara – 391510, Gujarat.DissolutionDrug Control Department AssamRDTL Guwahati
20.Paracetamol Tablets IP (DIXMOL – 650)B. No.: RT-235 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Ruzette Organics, Plot No. D-DissolutionDrug Control Department AssamRDTL Guwahati
  28, Industrial Area Focal Point, Derabassi, Distt. S.A.S. Nagar – 140507, Punjab.   
21.Ofloxacin and Ornidazole Tablets IP (Ofoxo-OZ Tablet)B. No.: KHP-201218 Mfg dt: 12/2020 Exp dt: 11/2022 Mfd by: M/s. Preet Remedies Ltd., 183-186, HPSIDC, Industrial Area, Baddi – 173205, Himachal Pradesh.DissolutionDrug Control Department AssamRDTL Guwahati
22.Codine Phasphate & Chlorpheniramine Maleat SyrupB. No.: BLJ-0120 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. BALAJI ENTERPRISES Vill-Messa Tibba, Tehsil, Nalagarh, Dist. Solan – 174101, Himachal Pradesh.MisbrandedDrug Control Department JharkhandRDTL Guwahati
23.Paracetamol Tablets IP 650 mgB. No.: BTPT-107 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. ANG Lifesciences India Ltd. Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan- 173205 – Himachal Pradesh.DissolutionDrug Control Department AssamRDTL Guwahati
24.Ciprofloxacin Tablets IPB. No.: AFT21002SL Mfg dt: 07/2021 Exp dt: 06/2024 Mfd by: M/s. Shiva Biogenetic Laboratories Pvt. Ltd. Village, Manpura, Baddi, Dist. Solan, Himachal Pradesh – 174101.DissolutionDrug Control Department JharkhandRDTL Guwahati
25.CANATE (Antioxidant Tablets with Vitamins and Minerals)B. No.: CT0771G Mfg dt: 07/2021 Exp dt: 06/2024 Mfd by: M/s. Ajanta Pharma Limited, Mfd At: Gut No.11/12/14/15,Selenium DioxideCDSCO East Zone KolkataCDL Kolkata
  Paithan Road, Chitegaon, Aurangabad – 431 105, Maharashtra.   
26.Cefixime Dispersible Tablets I.P. 100 mgB. No.: RCET002 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Revat Laboratories Pvt. Ltd., 12-321, Opp. I.D.A. Kurnool Road, Pernamitta, Ongole – 523 002, Andhra Pradesh.AssayCDSCO East Zone KolkataCDL Kolkata
27.Thyroxinol-150 Tablets (Thyroxine Tablets IP 150 mcg)B. No.: 2202084C Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Biodeal Pharmaceuticals Pvt. Ltd., Vill. Saini Majra, Nalagarh- Ropar Road, Nalagarh -174101, Dist. Solan, Himachal Pradesh, India.AssayCDSCO East Zone KolkataCDL Kolkata
28.CalciQuick-500 (Calcium and Vitamin D3 Tablets I.P.)B. No.: T-1B0038 Mfg dt: 02/2021 Exp dt: 01/2023 Mfd by: M/s. Morepen Laboratories Ltd., Morepen Village, Malkumajra, Baddi, Distt. Solan, Himachal Pradesh -173205.Identification & Assay of Vitamin D3CDSCO East Zone KolkataCDL Kolkata
29.Tinidazole Tablets I.P. 300 mgB. No.: JKGJ20001 Mfg dt: 03/2020 Exp dt: 02/2024 Mfd by: M/s. Cadila Pharmaceticals Ltd., Industrial Growth Center, SIDCO, Samba 184121, State of Jammu & Kashmir..DisintegrationCDSCO East Zone KolkataCDL Kolkata
30.Zinc Sulphate Dispersible Tablets IPB. No.: ZST21053 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. La- Chemico Pvt. Ltd., Taki Road, Kadambagachi, Barasat, North 24-DisintegrationCDSCO East Zone KolkataCDL Kolkata
  Parganas, Kolkata- 700125, West Bengal.   
31.P- Solone -10 (Prednisolone Tablet IP 10 mg)B. No.: CN2106 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Century Drugs Pvt. Ltd., Plot No. 38, Sector – 3, Pithampur, Dist. Dhar, Madhya Pradesh.Dissolution & AssayCDSCO East Zone KolkataCDL Kolkata
32.Zinc Sulphate Dispersible Tablets IPB. No.: ZST21054 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. La- Chemico Pvt. Ltd., Taki Road, Kadambagachi, Barasat, North 24- Paraganas, Kolkata- 700125, West Bengal.DisintegrationCDSCO East Zone KolkataCDL Kolkata
33.Care Zinc Tablets (Zinc Sulphate Dispersible Tablets IP 20 mg)B. No.: T210292 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. United Bioceuticals Pvt. Ltd., Plot No. 33C, Industrial Park-IV, Begumpur, Haridwar – 249 402, Uttarakhand.DisintegrationCDSCO East Zone KolkataCDL Kolkata
34.Nutrozyme Plus 200 ml (Alpha Amylase and Pepsin Syrup)B. No.: CLNC1002 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Crest Lifesciences Pvt. Ltd., Plot No. 127-128, EPIP, Phase -1, Jharmajri, Tehsil Baddi, Dist. Solan, Himachal Pradesh – 174 103.AssayCDSCO South Zone ChennaiCDL Kolkata
35.Nutrozyme 200 ml (Diastase and Pepsin Syrup)B. No.: CLNC0010 Mfg dt: 12/2020 Exp dt: 11/2022 Mfd by: M/s. Crest Lifesciences Pvt. Ltd., Plot No. 127-128, EPIP, Phase – I, Jharmajri, Tehsil Baddi, Dist. Solan, Himachal Pradesh- 174 103.AssayCDSCO South Zone ChennaiCDL Kolkata
36.Fical-500 (CalciumB. No.: GFM02 2102DescriptionCDSCO SouthCDL
 Carbonate & Vitamin D3 Tablets IP),Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Progressive Lifesciences Pvt. Ltd., Latherdevahoon, P.O. Jhabrera, Roorkee, Distt. Haridwar – 247665, Uttarakhand.& AssayZone ChennaiKolkata
37.Velol XL- AM 25 (Metoprolol Succinate Prolonged Release & Amlodipine Tablets I.P.)B. No.: KT1021290 Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. Kausikh Therapeutics (P) Ltd., Plot No. 6 & 7, Door No. 728, Kakkanji Cross Street, Paraniputhur Road, Gerugambakkam, Chennai -600128.Dissolution & AssayCDSCO South Zone ChennaiCDL Kolkata
38.Benolipe (Benfotiamine, Mecobalamin, Alpha Lipoic Acid, Pyridoxine Hydrochloride and Folic Acid Capsules)B. No.: MLC-2146 Mfg dt: 08/2021 Exp dt: 01/2023 Mfd by: M/s. Medishines Laboratories (P) Ltd., 156/6, Vinayagar Koil Street, Thirubhuvanai Palayam, Puducherry 605107.Description & Assay of Alpha Lipoic AcidCDSCO South Zone ChennaiCDL Kolkata
39.Compound Sodium Lactate Injection IP 500 ml (RL) (Ringer Lactate Solution for Injection)B. No.: S2FBV18 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Swaroop Pharmaceuticals Pvt. Ltd., A-10, Tala Nagari Industrial Area, Aligarh – 202 001, Uttar Pradesh.SterilityDrug Control Department OdishaCDL Kolkata
40.Levocetirizine Dihydrochloride and Montelukast Sodium Tablets IP)B. No.: 21112704 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Mercury Laboratories Ltd. Unit No. 2, Halol Baroda Road, Vill. Jarod, Tal. Waghodia, Dist. Vadodara -391510, Gujarat.DissolutionCDSCO GuwahatiCDL Kolkata
41.Levocetirizine Dihydrochloride andB. No.: 22112701 Mfg dt: 01/2022DissolutionCDSCO, GuwahatiCDL Kolkata
 Montelukast Sodium Tablets IP)Exp dt: 12/2023 Mfd by: M/s. Mercury Laboratories Ltd. Unit No. 2, Halol Baroda Road, Vill. Jarod, Tal. Waghodia, Dist. Vadodara -391510.   
42.Ofloxacin & Ornidazole Tablets IPB. No.: TB1030A Mfg dt: 02/2021  Exp dt: 01/2023  Mfd by: M/s. Navkar Lifesciences, Plot No. 76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan, Himachal Pradesh.DissolutionCDSCO, GuwahatiCDL Kolkata
43.Ofloxacin & Ornidazole Tablets IPB. No.: TB1045A Mfg dt: 02/2021  Exp dt: 01/2023  Mfd by: M/s. Navkar Lifesciences, Plot No. 76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan, Himachal Pradesh.Dissolution & AssayCDSCO, GuwahatiCDL Kolkata
44.VERMACT – 12 (Ivermectin Dispersible Tablets)B. No.: B8FHU016 Mfg dt: 05/2021 Exp dt: 04/2024 Mfd by: M/s. Innova Captab Ltd., 1281/1, Hilltop Industrial Estate, Near EPIP Phase -1, Jharmajri, Baddi, Dist. Solan, Himachal Pradesh – 173 205..Uniformity of DispersionCDSCO East Zone KolkataCDL Kolkata
45.RL-500, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection)B. No.: S2FBV27 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Swaroop Pharmaceuticals Pvt. Ltd., A-10, Tala Nagari Industrial Area, Aligarh – 202 001, Uttar Pradesh.Bacterial EndotoxinsDrug Control Department OdishaCDL Kolkata
46TOPERCIL – 4.5 gm (Piperacillin & Tazobactam Injection IP)B. No.: AB151048B Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Bengene Life Sciences Pvt. Ltd., Village Kishanpura,AssayCDSCO South Zone ChennaiCDL Kolkata
  P.O. Manpura, Baddi- Nalagarh Road, Tehsil – Nalagarh, Dist. Solan, Himachal Pradesh- 174101.   
47Snelgy-M (Montelukast 10 mg & Levocetirizine 5 mg Tablets)B. No.: T21G003 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Snehal Pharma & Surgicals Pvt. Ltd., B-1/11, B-2/1, M.I.D.C., Butibori, Nagpur – 441122, Maharashtra.DissolutionCDSCO Sub – Zone GoaCDTL Mumbai
48Thyroxium 25 mcg (Thyroxine Tablets I.P.)B. No.: 2203052A Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Biodeal Pharmaceuticals Pvt. Ltd., Vill, Saini Majra, Nalagarh-Ropar Road, Nalagrah- 174101, Distt. Solan, Himachal Pradesh.Assay and DissolutionCDSCO West Zone MumbaiCDTL Mumbai
49Thyroxium 100 mcg (Thyroxine Tablets I.P.)B. No.: 2203078 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Biodeal Pharmaceuticals Pvt. Ltd., Vill, Saini Majra, Nalagarh-Ropar Road, Nalagrah- 174101, Distt. Solan, Himachal Pradesh.AssayCDSCO West Zone MumbaiCDTL Mumbai
50.PHENYLEPHRINE HYDROCHLORIDE I.P.B. No.: CPHE-IV20009 Mfg dt: 06/2020 Exp dt: 05/2025 Mfd by: M/s. KREBS BIOCHEMICALS & INDUSTRIES LIMITED, Regadichelika Village, Kodavalpur Mandal Nellore District, Andhra Pradesh-524316.Specific Optical Rotation and Related SubstancesCDSCO Sub-Zone BaddiRDTL Chandigarh
51.Cefuroxime Axetil Tablets IP (FOLECEF-500 TABLETS)B. No.: EXDP-0280 Mfg dt: 08/2021 Exp dt: 07/2023 Mfd by: M/s. ETHIX HEALTH CARE #82/33, Kalka-ShimlaDissolutionCDSCO North -ZoneRDTL Chandigarh
  Highway, Deonghat, Saproon, Solan, Himachal Pradesh – 173211.   
52.ZINC SULPHATE DISPERSIBLE TABLETS I.P. 20mgB. No.: RZNT-023 Mfg dt: 08/2021 Exp dt: 07/2023 Mfd by: M/s. Revat Laboratories Pvt. Ltd., 12-321, Opp. I.D.A. Kurnool Road, Pernamitta, Ongole- 523002, Andhra Pradesh.Disintegration and Assay Uniformity of weight, Uniformity of dispersionCDSCO VisakhapatnamCDTL Hyderabad
53.FEXOFENADINE HYDROCHLORIDE TABLETS I.P.B. No.: GT211107 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Theon Pharmaceuticals Ltd., Village Saini Majra, Teh, Nalagarh, Distt. Solan, Himachal Pradesh – 174101.DissolutionCDSCO Zonal Office HyderabadCDTL Hyderabad
54.ENALAPRIL MALEATE TABLETS I.P. 5mgB. No.: T012001 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. ANG Lifesciences India Ltd., Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan- 173205, Himachal Pradesh.Description ,Dissolution and AssayCDSCO Zonal Office HyderabadCDTL Hyderabad


CDSCO declared Not of Standards Drugs and Cosmetics July 2022

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