CDSCO declared Not of Standards Drugs and Cosmetics July 2022
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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 tested | 1337 |
| Total number of samples declared as of Standard Quality | 1283 |
| Total number of samples declared as Not of Standard Quality | 53 |
| Total number of samples declared as Spurious | – |
| Total number of samples declared as Misbranded | 1 |
| S.No. | Name of Drugs/medical device/cosmetics | Batch No./Date of Manufacture/Date of Expiry/Manufactured By | Reason for failure | Drawn By | From |
| 1. | Rabeprazole Gastro Resistant Tablets I.P. 20mg | B. 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. | Assay | Drug Control Department Bihar | RDTL Guwahati |
| 2. | Paracetamol Tablets IP 650mg | B. 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 & Dissolution | Drug Control Department Assam | RDTL Guwahati |
| 3. | Ofloxacin & Ornidazole Tablets IP | B. 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. | Dissolution | Drug Control Department Assam | RDTL 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, | Description | Drug Control Department Bihar | RDTL Guwahati |
| Pernamitta, Ongole- 523002, Andhra Pradesh. | |||||
| 5. | Levocetirizine Dihydrochloride Tablets IP 5 mg | B. 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. | Dissolution | Drug Control Department Assam | RDTL 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. | Description | Drug Control Department Bihar | RDTL 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. | Description | Drug Control Department Bihar | RDTL Guwahati |
| 8. | Rabeprazole Sodium(E.C.) & Itopride Hydrochloride Sustained Release Capsules | B. 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. | Assay | Drug Control Department Assam | RDTL Guwahati |
| 9. | Ofloxacin & Ornidazole Tablets IP | B. 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. | Dissolution | CDSCO Sub- Zone Guwahati | RDTL 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. | Assay | Drug Control Department Assam | RDTL 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 Substances | Drug Control Department Assam | RDTL Guwahati |
| 12. | Rabeprazole Gastro Resistant Tablets IP 20 mg | B. 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 & Assay | Drug Control Department Bihar | RDTL 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 & Assay | Drug Control Department Jharkhand | RDTL Guwahati |
| 14. | Levocetirizine Dihydrochloride Tablets IP 5 mg | B. 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. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
| 15. | Telmisartan Tablets IP 40 mg | B. No.: TETY-01 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. NESTOR | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
| PHARMACEUTICALS LIMITED, 11, Western Extension Area, Faridabad-121001, Haryana, INDIA. | |||||
| 16. | Ofloxacin & Ornidazole Tablets IP | B. 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. | Dissolution | Drug Control Department Assam | RDTL 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. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
| 18. | Rabeprazole Gastro-Resistant Tablets IP | B. 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 & Description | Drug Control Department Assam | RDTL Guwahati |
| 19. | Levocetirizine Dihydrochloride & Montelukast Sodium Tablets IP | B. 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. | Dissolution | Drug Control Department Assam | RDTL 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- | Dissolution | Drug Control Department Assam | RDTL 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. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
| 22. | Codine Phasphate & Chlorpheniramine Maleat Syrup | B. 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. | Misbranded | Drug Control Department Jharkhand | RDTL Guwahati |
| 23. | Paracetamol Tablets IP 650 mg | B. 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. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
| 24. | Ciprofloxacin Tablets IP | B. 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. | Dissolution | Drug Control Department Jharkhand | RDTL 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 Dioxide | CDSCO East Zone Kolkata | CDL Kolkata |
| Paithan Road, Chitegaon, Aurangabad – 431 105, Maharashtra. | |||||
| 26. | Cefixime Dispersible Tablets I.P. 100 mg | B. 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. | Assay | CDSCO East Zone Kolkata | CDL 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. | Assay | CDSCO East Zone Kolkata | CDL 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 D3 | CDSCO East Zone Kolkata | CDL Kolkata |
| 29. | Tinidazole Tablets I.P. 300 mg | B. 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.. | Disintegration | CDSCO East Zone Kolkata | CDL Kolkata |
| 30. | Zinc Sulphate Dispersible Tablets IP | B. No.: ZST21053 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. La- Chemico Pvt. Ltd., Taki Road, Kadambagachi, Barasat, North 24- | Disintegration | CDSCO East Zone Kolkata | CDL 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 & Assay | CDSCO East Zone Kolkata | CDL Kolkata |
| 32. | Zinc Sulphate Dispersible Tablets IP | B. 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. | Disintegration | CDSCO East Zone Kolkata | CDL 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. | Disintegration | CDSCO East Zone Kolkata | CDL 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. | Assay | CDSCO South Zone Chennai | CDL 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. | Assay | CDSCO South Zone Chennai | CDL Kolkata |
| 36. | Fical-500 (Calcium | B. No.: GFM02 2102 | Description | CDSCO South | CDL |
| 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. | & Assay | Zone Chennai | Kolkata | |
| 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 & Assay | CDSCO South Zone Chennai | CDL 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 Acid | CDSCO South Zone Chennai | CDL 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. | Sterility | Drug Control Department Odisha | CDL 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. | Dissolution | CDSCO Guwahati | CDL Kolkata |
| 41. | Levocetirizine Dihydrochloride and | B. No.: 22112701 Mfg dt: 01/2022 | Dissolution | CDSCO, Guwahati | CDL 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 IP | B. 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. | Dissolution | CDSCO, Guwahati | CDL Kolkata |
| 43. | Ofloxacin & Ornidazole Tablets IP | B. 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 & Assay | CDSCO, Guwahati | CDL 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 Dispersion | CDSCO East Zone Kolkata | CDL 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 Endotoxins | Drug Control Department Odisha | CDL Kolkata |
| 46 | TOPERCIL – 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, | Assay | CDSCO South Zone Chennai | CDL Kolkata |
| P.O. Manpura, Baddi- Nalagarh Road, Tehsil – Nalagarh, Dist. Solan, Himachal Pradesh- 174101. | |||||
| 47 | Snelgy-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. | Dissolution | CDSCO Sub – Zone Goa | CDTL Mumbai |
| 48 | Thyroxium 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 Dissolution | CDSCO West Zone Mumbai | CDTL Mumbai |
| 49 | Thyroxium 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. | Assay | CDSCO West Zone Mumbai | CDTL 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 Substances | CDSCO Sub-Zone Baddi | RDTL 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-Shimla | Dissolution | CDSCO North -Zone | RDTL Chandigarh |
| Highway, Deonghat, Saproon, Solan, Himachal Pradesh – 173211. | |||||
| 52. | ZINC SULPHATE DISPERSIBLE TABLETS I.P. 20mg | B. 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 dispersion | CDSCO Visakhapatnam | CDTL 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. | Dissolution | CDSCO Zonal Office Hyderabad | CDTL Hyderabad |
| 54. | ENALAPRIL MALEATE TABLETS I.P. 5mg | B. 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 Assay | CDSCO Zonal Office Hyderabad | CDTL Hyderabad |