53 Drug Samples Fail To Clear CDSCO Test, 1 Declared Misbranded
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 53 medicine batches for failing to qualify for a random drug sample test for the month of July, while one drug sample has been declared misbranded.
These drugs samples which are declared not of standard quality include Cadila Pharmaceticals' Tinidazole Tablets I.P. 300 mg, Theon Pharmaceuticals' Fexofenadine hydrochloride tablets i.p., United Bioceuticals' Care Zinc Tablets (Zinc Sulphate Dispersible Tablets IP 20 mg), Navkar Lifesciences' Ofloxacin & Ornidazole Tablets IP and others.
This came after analysis and test were conducted by the CDSCO, Drugs Control Departments on 1337 samples. Out of this, 1283 samples were found of standard quality while 53 of them were declared as Not of Standard Quality (NSQ), while one drug was misbranded.
Further, the list contains one misbranded drug Balaji enterprise's Codine Phasphate & Chlorpheniramine Maleat Syrup.
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of disintegration test, failure of sterility test failure of the sterility test.
The samples collected were tested in five laboratories, namely CDTL Hyderabad, CDL Kolkata, CDTL Mumbai, RDTL Guwahati, RDTL Chandigarh.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of July – 2022.
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- | Description | Drug Control Department Bihar | RDTL Guwahati |
523 002, Andhra | |||||
Pradesh. | |||||
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 | 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 | RDTL |
Sodium(E.C.) & | Department | Guwahati | |||
Itopride | Assam | ||||
Hydrochloride | |||||
Sustained Release | |||||
Capsules | |||||
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, | Dissolution | CDSCO Sub- Zone Guwahati | RDTL Guwahati |
Himachal Pradesh. |
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 |
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