Drug alert: CDSCO flags 27 medicine batches as not of standard quality
New Delhi: In its latest drug safety alert, the Central Drugs Standard Control Organization (CDSCO) has flagged 27 medicine batches as not of Standard Quality for the month of April 2022. The drugs samples include Morepen Labs' CalciQuick-500, Abbott's Ursodeoxycholic Acid Tablets IP 300mg, Alkem Health Science's Amoxicillin and Potassium Clavulanate Tablets, Sun Pharma's Pantoprazole Gastro Resistant and Domperidone Prolonged-Release Capsules.
This came after analysis and test were conducted by the CDSCO, Drugs Control Departments on 1164 samples. Out of this, 1137 samples were found of standard quality while 27 of them were declared as Not of Standard Quality. No sample was found as spurious and misbranded.
Some of the reasons for the failure of drugs are dissolution, Assay of Vitamin D3, description, related substances of Silodosin.
The samples collected were tested in four laboratories namely CDL Kolkata, CDTL Mumbai, CDTL Hyderabad, RDTL Guwahati.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of April 2022, reads;
| Total number of samples tested | 1164 |
| Total number of samples declared as of Standard Quality | 1137 |
| Total number of samples declared as Not of Standard Quality | 27 |
| Total number of samples declared as Spurious | 0 |
| Total number of samples declared as Misbranded | 0 |
| 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 Tablets I.P. 20 mg | B. No.: RPR-117 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. C.I. Laboratories, 24 - B, B. L. Shah Road, Kolkata 700053. | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
| 2. | CalciQuick-500 (Calcium and Vitamin D3 Tablets I.P.) | B. No.: T-1H0250 Mfg dt: 08/2021 Exp dt: 07/2023 Mfd by: M/s. Morepen Laoratories Ltd., Morepen Village, Malkumajra, Baddi, Dist. Solan, Himachal Pradesh – 173 205. | Assay of Vitamin D3 | CDSCO East Zone Kolkata | CDL Kolkata |
| 3. | Ofloxacin & Ornidazole Tablets IP | B. No.: TB1058A Mfg dt: 02/2021 Exp dt: 01/2023 Mfd by: M/s. Navkar Life Sciences, Plot No. 76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan, Himachal Pradesh. | Description & Dissolution | CDSCO Guwahati | CDL Kolkata |
| 4. | Alphacept - D4 (Silodosin and Dutasteride Tablets) | B. No.: SGUL0192 Mfg dt: 09/2021 Exp dt: 08/2023 Mfd by: M/s. Swiss Garnier Genexiaa Sciences Pvt. Ltd., (Unit II), Plot No. 568- 569 & 576-579, Tarpin Block, Rhenock, Rongli East Sikkim 737133. | Related Substances of Silodosin | CDSCO South Zone Chennai | CDL Kolkata |
5. | Alprazolam Tablets IP 0.25 mg | B. No.: SUO2102 Mfg dt: 09/2021 Exp dt: 08/2023 Mfd by: M/s. Coral Laboratories Ltd., Plot No. 27/28, Pharmacity Selaqui, Dehradun - 248011, Uttarakhand, India. | Assay | CDSCO South Zone Chennai | CDL Kolkata |
6. | Alphacept – D8 (Silodosin and Dutasteride Tablets) | B. No.: SGUL0191 Mfg dt: 09/2021 Exp dt: 08/2023 Mfd by: M/s. Swiss Garnier Genexiaa Sciences Pvt. Ltd., (Unit II), Plot No. 568- 569 & 576-579, Tarpin Block, Rhenock, Rongli East Sikkim 737133. | Related Substances of Silodosin | CDSCO South Zone Chennai | CDL Kolkata |
7. | Sodium Valproate Tablets I.P. 200 mg | B. No.: BT5871 Mfg dt: 08/2021 Exp dt: 07/2023 Mfd by: M/s. Brilliant Lifesciences Pvt Ltd., At Chuval Dangarwa, Ta.- Detroj Distt. Ahmedabad, Gujarat. | Dissolution | CDSCO West Zone Mumbai | CDTL Mumbai |
8. | Albithral 500 (Azithromycin Tablets IP) | B. No.: DD21007 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Skymap Pharmaceutical Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee – 247667, Uttarakhand. | Description | CDSCO West Zone Mumbai | CDTL Mumbai |
9. | Diaset 1 (Glimepiride Tablets I.P. 1 mg) | B. No.: C22F81 Mfg dt: 09/2021 Exp dt: 08/2024 Mfd by: M/s. Stadmed Private Limited, 15,Jawpore Road, Kolkata 7000074. | Dissolution | CDSCO South Zone Goa | CDTL Mumbai |
| 10. | Glimepiride & Metformin Hcl (Sustaned Release) Tablets (Synopride- M4 Forte) | B. No.: AT2110122A Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. ADDII BIOTECH PVT. LTD., ViLL. Kaundi, P.P. Thana, Tah. Baddi, Distt. Solan – 173205, Himachal Pradesh. | Dissolution | CDSCO Zonal Office Hyderabad | CDTL Hyderabad |
| 11. | Ampicillin Capsules IP | B. No.: AMI-1901 Mfg dt: 07/2019 Exp dt: 06/2022 Mfd by: M/s. Ridley Lifescience Pvt. Ltd., D-1651, DSIDC, Indl. Complex, Narela, Delhi-110040. | Assay and Misbranded | Drug Control Department Arunachal Pradesh | RDTL Guwahati |
| 12 | Ibuprofen Tablets IP 400 mg | B. No.: BPT20003 Mfg dt: 09/2020 Exp dt: 08/2022 Mfd by: M/s. Vivek Pharmachem ( India) Limited., NH-8, Chimanpura, Amer, Jaipur – 303102, Rajasthan. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
| 13. | Paracetamol, Phenylephrine Hydrochloride, Caffeine and Diphenhydramine Hydrochloride (SNEZEE 500) | B. No.: TP1020810 Mfg dt: 10/2020 Exp dt: 09/2022 Mfd by: M/s. Maxrelief Healthcare, Vill. Anji, Solan, Himachal Pradesh- 173212. | Identification and Assay | Drug Control Department Jharkhand | RDTL Guwahati |
| 14. | Ibuprofen Tablets I.P. 400 mg | B. No.: BPT20005 Mfg dt: 09/2020 Exp dt: 08/2022 Mfd by: M/s. Vivek Pharmachem ( India) Ltd.,NH-8, Chimanpura, Amer, Jaipur-303102, Rajasthan. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
| 15. | Amlodipine Tablets IP | B. No.: TL20-25 Mfg dt: 12/2020 Exp dt: 11/2022 Mfd by: M/s. Om Biomedic Pvt. Ltd., Plot NO. 68, 69, 82 & 83, Sector-6A, IIE, SIDCUL, Haridwar- 249403, Uttarakhand. | Assay | Drug Control Department Meghalaya | RDTL Guwahati |
16. | Paracetamol Tablets IP | B. No.: ADT-08-0541 Mfg dt: 08/2020 Exp dt: 07/2022 Mfd by: M/s. Adwin Pharma, Vill- Rampur Jattan, Trilokpur Road, Kala-Amb, Tehsil- Nahan, Distt. Sirmour, Himachal Pradesh - 173030. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
17. | Ursodeoxycholic Acid Tablets IP 300mg (Udiliv 300) | B. No.: 250923D7 Mfg dt: 01/2021 Exp dt: 05/2023 Mfd by: M/s. Abbott India Limited, L-18/19, Verna Industrial Area, Verna, Salcette, Goa- 403722. | Identification and Assay | Drug Control Department Assam | RDTL Guwahati |
18. | Telmisartan Tablets IP 40mg | B. No.: TETY-01 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. Nestor Pharmaceuticals Limited, 11, Western Extension Area, Faridabad - 121001, Haryana, INDIA. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
19. | Levocetirizine Dihydrochloride and Montelukast Sodium Tablets IP | B. No.: 21112701 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Mercury Laboratories Ltd. Unit No. 2, Halol-Baroda Road, Village:Jarod, Tal. Waghodia, Dist. Vadodara-391510, Gujarat. | Dissolution | CDSCO Sub - Zone Guwahati | RDTL Guwahati |
20. | Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP | B. No.: LMT21001MB Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Sri Ram Healthcare Pvt. Ltd., 81-C/2, EPIP-I, Jharmajri, Baddi, Distt. Solan, Himachal Pradesh -173205. | Dissolution | Drug Control Department Assam | RDTL Guwahati |
21. | Amoxicillin and Potassium Clavulanate Tablets IP | B. No.: 21441454 Mfg dt: 05/2021 Exp dt: 10/2022 Mfd by: M/s. Alkem Health Science A Unit of Alkem Laboratories Limited, Unit-2, Samardung, Karek Block, PO. Nanthang, South Sikkim- 737137. | Assay | Drug Control Department Assay | RDTL Guwahati |
22. | Pantoprazole Gastro Resistant and Domperidone Prolonged-Release Capsules IP | B. No.: RPB0651A Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. Sun Pharma Laboratories Ltd., Plot No. 107-108, Namli Block, P.O. Ranipool, East Sikkim- 737135. | Identification and Assay | Drug Control Department Assay | RDTL Guwahati |
23. | Misoprostol Tablets I.P. 200mcg | B. No.: MOT20002 Mfg dt: 06/2020 Exp dt: 05/2022 Mfd by: M/s. Vivek Pharmachem ( India) Ltd., NH-8, Chimanpura, Amer, Jaipur-303102, Rajasthan. | Assay | Drug Control Department Assay | RDTL Guwahati |
24. | Omeprazole Capsules IP | B. No.: CO40-001 Mfg dt: 06/2020 Exp dt: 05/2022 Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Baddi, Distt. Solan, Himachal Pradesh, INDIA. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
25. | Omeprazole Capsules IP | B. No.: CO40-002 Mfg dt: 06/2020 Exp dt: 05/2022 Mfd by: M/s. Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Baddi, Distt. Solan, Himachal Pradesh, INDIA. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
26. | Primaquine Tablets I.P. 2.5 mg | B. No.: AHT-2768 Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. Algen Healthcare Limited, 134/2, Vill. Khara Khari, Sadhaura Road, Kala Amb, Distt. Sirmour, Himachal Pradesh – 173030. | Dissolution and Assay | CDSCO Sub-Zone Guwahati | RDTL Guwahati |
27. | Calcium Lactate Vit. D3, Cyanocobalamine, L-Lysine Hcl & L- Glutamic Acid | B. No.: D11 Mfg dt: 05/2020 Exp dt: 04/2022 Mfd by: M/s. Swiss-de- cheme At: Mithanpura- 842002, H.O. 96, Lock Gate Road, Sri Krishnapur, P.O. Kulghacia, Distt. Howrah- 711306, West Bengal. | Assay | Drug Control Department Bihar | RDTL Guwahati |
For more details, check out a full notice on the link below:
https://medicaldialogues.in/pdf_upload/drug-alert-listapril-222094.pdf
