Drug Alert: CDSCO Flags 48 Formulations As Not Of Standard Quality
New Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drug Standard Control Organization (CDSCO), has flagged 48 medicine batches for failing to qualify for a random drug sample test for August– 2024.
These include Amoxycillin and Potassium Clavulanate Tablets (Mexclav 625) manufactured by Meg Lifscience, Calcium and Vitamin D3 Tablets IP Shelcal 500 (Shelcal) manufactured by Pure and Cure Healthcare, Metformin Hydrochloride Sustained-release Tablets IP (Glycimet-SR-500) manufactured by Scott-Edil, Vitamin B Complex with Vitamin C Softgels manufactured by Asoj Soft Caps, Rifmin 550 (Rifaximin Tablets 550 mg) manufactured by Legen Healthcare, Paracetamol Tablets IP 500 mg manufactured by Karnakata Antibiotics, Montair LC Kid (Montelukast Sodium & Levocetirizine Hydrochloride Dispersible Tablets) manufactured by Pure & Care Healthcare, and others.
Furthermore, the list includes popular medicines Amoxicillin and Potassium Clavulanate (Clavam 625) tablets manufactured by Alkem Pharmaceuticals, and Pantoprazole Gastro-Resistant and Domperidone Prolonged-Release Capsules IP (Pan-D) manufactured by Alken Health Science.
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of uniformity of weight, failure of completeness of solution, clarity of solution and particulate matter, failure of pH, particulate matter, and description.
The samples collected were tested in four laboratories: RDTL Chandigarh, CDL Kolkata, CDTL Mumbai, and RDTL-Guwahati.
NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF AUGUST – 2024.
A. CDSCO/Central Laboratories | |||||||
S.No | Product/Drug Name | Batch No. | Manufacturing Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Amoxicillin And Potassium Clavulanate Tablets IP (Clavam 625) | 23443940 | 11/2023 | 04/2025 | M/s. Alkem Health Science, Unit-2, Samardung, Karek Block, P.O. Namthang, South Sikkim 737 137. | Spurious Identification & Assay of Amoxycillin Trihydrate & Potassium Clavulanate | CDL, Kolkata |
2. | Amoxycillin & Potassium Clavulanate Tablets (Mexclav 625) | 7372 | 10/2023 | 09/2025 | M/s. Meg Lifesciences, Khasara No. 47/5, Palli Gaon, Distt-Sirmour- 173001. | Spurious Identification & Assay of Amoxycillin Trihydrate & Potassium Clavulanate | CDL, Kolkata |
3. | Calcium And Vitamin D3 Tablets IP Shelcal 500 (Shelcal) | GDXD0581 | 08/2023 | 07/2025 | M/s. Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27-30, Sector-8A, IIE, SIDCUL, Ranipur, Haridwar - 249 403, Uttarakhand. | Description, Identification of Vitamin D3, Dissolution of Calcium and Assay of Calcium & Vitamin D3 | CDL, Kolkata |
4. | Metformin Hydrochloride Sustained-release Tablets IP (Glycimet-SR-500) | GT3J023 | 10/2023 | 09/2025 | M/s. Scott-Edil Pharmacia Ltd., 56, EPIP, Phase-1, Jharmajri, Baddi, Distt. Solan -173205 (HP), India | Dissolution of Metformin Hydrochloride | CDL, Kolkata |
5. | Vitamin B Complex with Vitamin C Softgels | 1423 | 09/2023 | 08/2025 | M/s. Asoj Soft Caps Pvt. Ltd., Asoj, Baroda-Halol Highway, Dist-Baroda- 391510, GUJRAT | Assay of Calcium Pantothenate | CDL, Kolkata |
6. | Rifmin 550 (Rifaximin Tablets 550 mg) | TX-17798 | 02/2024 | 01/2026 | M/s. Legen Healthcare, Plot No. 20, Sector-5, Parwanoo, Distt. Solan (H.P.) 173220 | Dissolution & Water | CDL, Kolkata |
7. | Pantoprazole Gastro-Resistant and Domperidone Prolonged-Release Capsules IP (Pan - D) | 23444296 | 12/2023 | 11/2025 | M/s. Alkem Health Science, Unit-2, Samardung, Karek Block, P.O. Namthang, Dist. Namchi, Sikkim 737 137. | Spurious Identification, Assay, Dissolution & Related Substancces | CDL, Kolkata |
8. | Paracetamol Tablets IP 500 mg | 2508323 | 02/2023 | 01/2026 | M/s. Karnataka Antibiotics and Pharmaceuticals Ltd., Plot No. 14, II Phase, Peenya, Bengaluru-560058 | Description | CDL, Kolkata |
9. | Montair LC Kid (Montelukast Sodium & Levocetirizne Hydrochloride Dispersible Tablets) | AFB23W73 | 09/2023 | 08/2025 | M/s. Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27-30, Sector-8A, IIE, Sidcul, Ranipur, Haridwar 249 403, Uttarkhand | Uniformity of Dispersion & Assay of Montelukast Sodium | CDL, Kolkata |
10. | Compound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection) (RL 500 ml) | MP24050511 1 | 05/2024 | 04/2027 | M/s. Vision Parenteral Pvt. Ltd. Located at A-2, 44,45, Sector-15, GIDA, Sahjanwa (U.P.) 273 209 | Assay of Calcium Chloride | CDL, Kolkata |
11. | Fexofenadine Hydrochloride Tablets IP 120 mg | MP9AA2303 | 07/2023 | 06/2026 | M/s. Maxtar Bio-Genics, Khasra No-705, Vill-Malku Majra, Nalagarh Road, Baddi, Distt-Solan- 173205(HP), India | Dissolution | CDL, Kolkata |
12. | Fexofenadine Hydrochloride Tablets IP 120 mg | MP9AA2303 (Two different | 07/2023 | 06/2026 | M/s. Maxtar Bio-Genics, Khasra No-705, Vill-Malku Majra, Nalagarh Road, | Dissolution | CDL, Kolkata |
samples received with same batch number) | Baddi, Distt-Solan- 173205(HP), India | ||||||
13. | Laxnorm Solution (Lactulose Solution USP) | LG24-0204 | 02/2024 | 01/2026 | M/s. Athens Life Sciences, Mauza Rampur Jattan, Nahan Road, Kala Amb, Dist-Sirmour, HP-173030 | Assay | CDL, Kolkata |
14. | Heparin Sodium Injection 5000 Units (Hostranil Injection) | HIHE23028A | 10/2023 | 09/2025 | M/s. Health Biotech Ltd., Village: Sandoli, Nalagarh Road, Baddi, Distt. Solan (H.P.), India-173205 | Particulate Matter, Bacterial Endotoxins & Sterility | CDL, Kolkata |
15. | Buflam Forte Suspension (Ibuprofen & Paracetamol Oral Suspension) | 231202A | 12/2023 | 11/2025 | M/s. Ornate Pharma Pvt. Ltd., 2, G.V.M.S.A.V Ltd., Odhav, Ahmedabad 382 410, Gujrat, India | Uniformity of Volume | CDL, Kolkata |
16. | Cepodem XP 50 Dry Suspension (Cefpodoxime Proxetil and Potassium Clavulanate Oral Suspension) | PEA0083 | 07/2023 | 12/2024 | M/s. Hetero Labs Limited (Unit-I), Village: Kalyanpur, Chakkan Road, Tehsil: Baddi, Dist: Solan, Himachal Pradesh - 173205. | pH and Assay of Potassium Clavulanate | CDL, Kolkata |
17. | Nimesulide, Paracetamol and Chlorzoxazone Tablets (NICIP MR) | GS22236 | 09/2022 | 08/2025 | M/s. HSN International Plot No. 54-55, Sector-6A, SIDCUL, Haridwar, (Uttarakhand) 249403 | Disintegration | CDL, Kolkata |
18. | Rolled Gauze (Non- Sterilized) | RG-006 | 01/2023 | 12/2024 | M/s. Blazon India, At: Musallahpur, Baripath, Patna-6 | Width, Absorbency, Scouring Loss, Freedom from Optical Whitener, Mass, Length | CDL, Kolkata |
19. | Ciprofloxacin Tablets I.P. 500 mg (Ocif-500) | OCF5-23- 221 | 05/2023 | 04/2025 | M/s. Ornate Labs Pvt. Ltd., Bela Industrial Estate, Muzaffarpur - 842 005 | Dissolution & Assay | CDL, Kolkata |
20. | Nimesulide, Phenylephrine | T-23115 | 01/2023 | 12/2024 | M/s. Unispeed Pharmaceuticals Pvt. Ltd., | Description | CDL, Kolkata |
Hydrochloride & Levocetirizine Dihydrochloride Tablets (Nunim- Cold) | 445/2, Behimd Wrigleys Vill. Katha, Baddi, Distt. Solan (H.P.) 173205 | ||||||
21. | Adrenaline Injection I.P. Sterile 1 ml | AI22268 | 09/2022 | 08/2024 | M/s. Alves Healthcare Pvt. Ltd., Nangal Uperla, Swarghat Road, Nalagarh, Distt. Solan-174101 (HP). | Description, Appearance of Solution, Particulate Matter & Assay | CDL, Kolkata |
22. | Compound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection) RL 500ml | MP24040508 5 | 04/2024 | 03/2027 | M/s. Vision Parentral Pvt. Ltd., A-2-44-45, Sector 15, GIDA Industrial Area, Gorakhpur 273209 (U.P.), India. | Sterility | CDL, Kolkata |
23. | Vingel XL Pro Gel (Diclofenac Diethylamine, Linseed Oil, Methyl Salicylate and Menthol Gel) | F23208 | 06/2023 | 05/2025 | M/s. Universal Twin Labs, Village Gullarwala, Near Sai Road, Baddi, District Solan, H.P. | Assay of Diclofenac Diethylamine & Methyl Salicylate | CDL, Kolkata |
24. | Atropine Sulphate Injection IP 2 ml | ATA12407 | 03/2024 | 02/2026 | M/s. Nandani Medical Laboratories Pvt. Ltd., 221/5, Bicholi Hapsi, Kanadia Road, Indore. | Description & Particulate Matter | CDL, Kolkata |
25. | Cefoperazone & Sulbactam For Injection (Todaycef 1.5 G) | D0481 | 11/2023 | 10/2025 | M/s. Daxin Pharmaceuticals Pvt. Ltd., Plot No. 121-122 EPIP, Jharmajri Phase-1, Teh. Baddi, Distt. Solan (H.P.) 174 103. | Clarity of Solution, Particulate matter and Assay | CDL, Kolkata |
26. | Heparin Sodium Injection IP 25000 IU / 5ml | GV3C002 | 03/2023 | 02/2026 | M/s. Scott-Edil Pharmacia Ltd., 56, E.P.I.P. Phase-1, Jharmajri, Baddi, Distt. Solan - 173 205 (H.P.), India | Description & Particulate Matter | CDL, Kolkata |
27. | Cefepime & Tazobactam for | I230041A | 04/2023 | 03/2025 | M/s. Cosmas Research Lab. Ltd., Village: | Particulate Matter | CDL, Kolkata |
Injection (Crupime - TZ Kid Injection) | Gaunspura, P.O. Noorpur Bet, Hambran, Ludhiana 141 008 | ||||||
28. | Atropine Sulphate Injection I.P. (Atropine Sulphate) | AS-9055 (Two different samples received with same batch number) | 10/2022 | 09/2024 | M/s. Priya Pharmaceuticals 109/397, Nehru Nagar, Kanpur-208012, Uttar Pradesh | Description, pH, Particulate Matter, Extractable Volume | CDL, Kolkata |
29. | Atropine Sulphate Injection I.P. (Atropine Sulphate) | AS-9055 (Two different samples received with same batch number) | 10/2022 | 09/2024 | M/s. Priya Pharmaceuticals 109/397, Nehru Nagar, Kanpur-208012, Uttar Pradesh | Description, pH, Particulate Matter, Extractable Volume | CDL, Kolkata |
30. | Atropine Sulphate Injection I.P. (Atropine Sulphate) | AS-9057 (Two different samples received with same batch number) | 04/2023 | 03/2025 | M/s. Priya Pharmaceuticals 109/397, Nehru Nagar, Kanpur-208012, Uttar Pradesh | Description, Particulate Matter, Extractable Volume, Assay | CDL, Kolkata |
31. | Atropine Sulphate Injection I.P. (Atropine Sulphate) | AS-9057 (Two different samples received with same batch number) | 04/2023 | 03/2025 | M/s. Priya Pharmaceuticals 109/397, Nehru Nagar, Kanpur-208012, Uttar Pradesh | Description, Particulate Matter, Extractable Volume, Assay | CDL, Kolkata |
32. | Salbutamol, Bromhexine HCI, Guaifenesin and Menthol Syrup(Acozil Expectorant) | A-244003 | 04/2024 | 03/2027 | M/s. Antila Lifesciences Pvt Ltd, Plot No. P-2, Savli Bio- Tech Park, At-Manjusar, Tal-Savli, Dist- Vadodara- 391775, Gujarat, | Not of Standard Quality | CDTL-Mumbai |
33. | Diclofenac Sodium IP | DFS- 2405031 | 05/2024 | 04/2029 | M/s. Sara Exports Ltd. Plot No. 35, 35/1 & 36, South Side of GT Road, Industrial Area, Ghaziabad-201009 Uttar Pradesh, | Not of Standard Quality | CDTL-Mumbai |
34. | Escitalopram and Clonazepam Tablets IP (Klozaps-ES Tablets) | NTD0203 | 12/2023 | 11/2025 | M/.s Digital Vision, 176, Mauza Ogli, Nahan Road, Kala-Amb, Distt. Sirmour (H.P.)-173030 | Assay of Escitalopram Oxalate calculated as Escitalopram and Clonazepam | RDTL, Chandigarh |
35. | Phenytoin Sodium Injection USP | HIPY23012C | 10/2023 | 09/2025 | M/.s Health Biotech Ltd., Village Sandoli, Nalagarh Road, Baddi, Distt. Solan (H.P.) India-173205 | Alcohol, Propylene Glycol and Particulate Matter | RDTL, Chandigarh |
36. | Paracetamol, Phenylephrine Hydrochloride and Cetirizine Hydrochloride Suspension (Cethel Cold DS Suspension) | WPS-013 | 04/2024 | 03/2026 | M/s. Win Cure Pharma, Plot No. 21, DIC, Baddi (H.P.) 173205 | Assay of Paracetamol, Phenylephrine Hydrochloride and Cetirizine Hydrochloride | RDTL, Chandigarh |
37. | Calcium 500 mg with Vitamin D3 250 IU Tablets IP | LMT231058 | 12/2023 | 11/2025 | M/s. Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector 6A, IIE, SIDCUL, Haridwar249403 (U.K) | Assay of Calcium and vitamin D3 and Dissolution of Calcium | RDTL, Guwahati |
38. | Amoxycillin and Potassium Clavulanate Tablets IP 625 mg (Renamega- CV 625) | MD19AA08 | 10/2023 | 09/2025 | M/s. Malik Lifesciences Pvt. Ltd. (A Subsidiary of Akums Drugs & Pharmaceuticals Ltd.) Plot No. Vardhman, Indl. Estate, N.H.58, Haridwar-247667 (Uttarakhand) | Assay and Uniformity of content of Clavulanic Acid and Dissolution of Amoxycillin and Clavulanic Acid | RDTL, Guwahati |
39. | Olmesartan Medoxomil Tablets IP 40 mg | LMT240387 | 03/2024 | 02/2026 | M/s. Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector 6A, IIE, | Dissolution of Olmesartan Medoxomil | RDTL, Guwahati |
SIDCUL, Haridwar249403 (U.K) | |||||||
40. | INFUSION SET-NV | KT-015 | 01/2024 | 12/2026 | M/s. MEDIVISION HEALTHCARE, 84/4 Span Industrial Complex. Second Floor, Phase-1, 'F' Road, Opp. Kotak Mahindra Bank, G.I. D.C. Vatva, Ahmedabad- 382445 | Sterility | RDTL, Guwahati |
41. | Telmisartan Tablets IP 40 mg | LMT240528 | 05/2024 | 04/2026 | M/s. Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector 6A, IIE, SIDCUL, Haridwar249403 (U.K) | Description | RDTL, Guwahati |
42. | Telmisartan Tablets IP 40 mg | LMT240502 | 04/2024 | 03/2026 | M/s. Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector 6A, IIE, SIDCUL, Haridwar249403 (U.K) | Description | RDTL, Guwahati |
43. | Telmisartan Tablets IP 40 mg | LMT240502 | 04/2024 | 03/2026 | M/s. Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector 6A, IIE, SIDCUL, Haridwar249403 (U.K) | Description | RDTL, Guwahati |
44. | Telmisartan Tablets IP 40 mg | 251TTF011 | 07/2023 | 06/2025 | M/s. Swiss Garnier Life Science, 21-23, Industrial Area, Mehatpur, Dist. Una, , Himachal Pradesh- 174315. Iindia | Dissolution | RDTL, Guwahati |
45. | Alprazolam Tablets IP 0.25 mg (Erazol- 0.25 Tablets) | 16747 | 08/2023 | 07/2025 | M/s. ELIKEM Pharmaceuticals Private Limited, 816/1, Rakanpur, Ta. Kalol, Dist. Gandhinagar, Guj. 382721 | Dissolution | RDTL, Guwahati |
46. | GLIMEPIRIDE TABLETS IP (2 mg) | MT234799 | 11/2023 | 10/2025 | M/s, Mascot Health Series Pvt. Ltd., 79 & 80, Sec-6A, IIE Sidcul Haridwar- 249403 | Description | RDTL, Guwahat |
47. | Calcium and Vitamin D3 Tablets I.P. | UDT11151 | 08/2023 | 01/2025 | M/s. Unicure India Ltd., C- 21, 22 & 23, Sector-3, Noida-201 301 Distt. Gautam Budh Nagar (U.P.) | Assay of vitamin D3 | RDTL, Guwahati |
48. | Metronidazole Tablets IP 400mg | HMAA04 | 07/2023 | 06/2025 | M/s. HINDUSTAN ANTIBIOTICS LTD. (A Government of India Enterprises) at 11, W.E. A. Faridabad - 121001 (Haryana) R.O.:Pimpri, Pune-411018,INDIA | Dissolution | RDTL, Guwahati |
Also Read:CDSCO Releases Draft Guidelines on Good Clinical Practices
