CDSCO Drug Alert: 67 Drug Samples Including Sun Pharma Pantocid DSR, Alkem's Pan -D flagged
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 67 medicine batches for failing to qualify for a random drug sample test for the month of January– 2023.
These drug samples include Rabeprazole Gastro Resistant Tablets IP 20 mg manufactured by Revat Laboratories, Itraconazole Capsules B.P. 100 mg manufactured by Navkar lifesciences, Phenytoin Sodium Tablets IP 100 mg manufactured by Jackson Laboratories, Misoprostol Tablets I.P. 200 mcg manufactured by Ridley Lifescience and others.
In addition to this, the name of Pantocid DSR (Pantoprazole Gastro-Resistant and Domperidon Prolonged Release Capsules IP) manufactured by Sun Pharma Laboratories is also on the list of samples declared as Not of Standard Quality due to failure of identification and assay of Pantocid DSR. Having said that, the alert also carries a remark noting that on response to the aforementioned alert, pharmaceutical giant Sun Pharma Laboratories has informed the CDSCO office regarding availability of Spurious/ Counterfeit of the said batch of drug.
"Accordingly samples were drawn during the raid. Further Investigation is under process." the CDSCO added to its note.
Furthermore, the list includes Teneligliptin Tablets I.P. 20mg (ZITEN) manufactured by Glenmark Pharmaceuticals, Trypsin Chymotrypsin Tablets (CHYMORAL FORTE TABLETS) manufactured by Torrent pharmaceuticls, Aceclofenac 100 mg & Thiocolchicoside 4 mg Tablets (Zerodol TH 4 Tablets) manufactured by Ipca Laboratories.
Popular marketed drug Pan -D (Pantoprazole Gastro-Resistant and Domperidone Prolonged Release Capsules IP) manufactured by Alkem Health Science, A unit of Alkem Laboratories Limited is also on the list.
The list came after analysis and test were conducted by the CDSCO, Drugs Control Departments on 1348 samples. Out of this, 1281 samples were found of standard quality while 67 of them were declared as Not of Standard Quality (NSQ).
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of the disintegration test, failure of pH and identification test, failure of clarity test, failure of specific assay of drug test and others.
The samples collected were tested in six laboratories RDTL Guwahati, CDL Kolkata, CDTL Chennai, CDTL Mumbai, CDTL Hyderabad, RDTL Chandigarh.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of January– 2023.
| Total number of samples tested | 1348 |
| Total number of samples declared as of Standard Quality | 1281 |
| Total number of samples declared as Not of Standard Quality | 67 |
| Total number of samples declared as Spurious | - |
| Total number of samples declared as Misbranded | - |
| 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 IP 20 mg | B. No.: RRZT-023 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 of Rabeprazole Sodium and Description | Drug Control Department Bihar | RDTL Guwahati |
| 2. | Rabeprazole Gastro Resistant Tablets IP 20 mg | B. No.: RRZT-021 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 of Rabeprazole Sodium and Description | Drug Control Department Bihar | RDTL Guwahati |
| 3. | CIPROFLOXACIN HYDROCHLORID E TABLETS I.P. 500 mg | B. No.: 0701522 Mfg dt: 06/2022 Exp dt: 05/2025 Mfd by: M/s. Karnataka Antibiotics & Pharmaceuticals Limited, Plot No. 14, II Phase, Peenya, Bengaluru – 560 058. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
| 4. | Lvcipro-500 (Ciprofloxacin Hydrochloride Tablets IP) | B. No.: LV22CT-691 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. L V Life Sciences, VPO Gurumajra, Baddi, Distt. Solan, Himachal | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
|
|
| Pradesh -174 101. |
|
|
|
| 5. | Ciprofloxacin Tablets IP 500 mg Cipronir 500 | B. No.: CCF111004 Mfg dt: 11/2021 Exp dt: 10/2024 Mfd by: M/s. Celebrity Biopharma Ltd. Village-Panga, Via- Jharmajri, Hill Top Estate, Barotiwala, Distt-solan, Himachal Pradesh- 174103. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
| 6. | Zinc Sulphate Oral | B. No.: ZS1-21-224 | Weight per ml | Drug | RDTL |
|
| Solution I.P., | Mfg dt: 01/2022 |
| Control | Guwahati |
|
| 100ml | Exp dt: 12/2023 |
| Department |
|
|
|
| Mfd by: M/s. Ornate Labs |
| Bihar |
|
|
|
| Pvt. Ltd. Bela Industrial |
|
|
|
|
|
| Estate, Muzaffarpur- |
|
|
|
|
|
| 842005, Bihar. |
|
|
|
| 7. | Zinc Sulphate Oral | B. No.: ZCH-2207 | Weight per ml | Drug | RDTL |
|
| Solution I.P., | Mfg dt: 01/2022 |
| Control | Guwahati |
|
| 100ml | Exp dt: 12/2023 |
| Department |
|
|
|
| Mfd by: M/s. Apple |
| Bihar |
|
|
|
| Formulations Pvt. Ltd. |
|
|
|
|
|
| Plot No. 208 Kishanpur, |
|
|
|
|
|
| Roorkee-247667, |
|
|
|
|
|
| Uttarakhand. |
|
|
|
| 8. | Telmisartan | B. No.: TETY-01 | Dissolution | Drug | RDTL |
|
| Tablets IP 40 mg | Mfg dt: 04/2021 |
| Control | Guwahati |
|
|
| Exp dt: 03/2023 |
| Department |
|
|
|
| Mfd by: M/s. NESTOR |
| Jharkhand |
|
|
|
| PHARMACEUTICALS |
|
|
|
|
|
| LIMITED. 11, Western |
|
|
|
|
|
| Extension Area, |
|
|
|
|
|
| Faridabad-121 001, |
|
|
|
|
|
| Haryana, INDIA. |
|
|
|
| 9. | Itraconazole | B. No.: CH2006A | Dissolution | Drug | RDTL |
|
| Capsules B.P. | Mfg dt: 08/2022 |
| Control | Guwahati |
|
| 100 mg | Exp dt: 07/2024 |
| Department |
|
|
|
| Mfd by: M/s. NAVKAR |
| Assam |
|
|
|
| LIFESCIENCES, Plot No. |
|
|
|
|
|
| 76, Lodhi Majra, |
|
|
|
|
|
| Industrial Area, Baddi, |
|
|
|
|
|
| Distt. Solan, Himachal |
|
|
|
|
|
| Pradesh. |
|
|
|
| 10. | B-complex | B. No.: UGC22020 | Description | Drug | RDTL |
|
| capsules | Mfg dt: 01/2022 |
| Control | Guwahati |
|
|
| Exp dt: 06/2023 |
| Department |
|
|
|
| Mfd by: M/s. UNIMARCK |
| Bihar |
|
|
|
| HEALTHCARE LTD., Plot |
|
|
|
|
|
| No. 24, 25 & 37, Sector- |
|
|
|
|
|
| 6A, SIDCUL, Haridwar- |
|
|
|
|
|
| 249 403 Uttarakhand. |
|
|
|
| 11. | ABSORBENT | B. No.: 1786 | NEPS | Drug | RDTL |
|
| COTTON WOOL | Mfg dt: 05/2021 |
| Control | Guwahati |
|
| I.P. | Exp dt: 04/2024 |
| Department |
|
|
|
| Mfd by: M/s. Om Surgical |
| Assam |
|
|
|
| Industries, V & P.O. Titoli, |
|
|
|
|
|
| Jind Road, Rohtak- 124 |
|
|
|
|
|
| 001, Haryana. |
|
|
|
| 12. | Rabeprazole | B. No.: RRZT-019 | Assay | Drug | RDTL |
|
| Gastro-Resistant | Mfg dt: 12/2021 | and | Control | Guwahati |
|
| Tablets IP 20 mg | Exp dt: 11/2023 | Description | Department |
|
|
|
| Mfd by: M/s. Revat |
| Bihar |
|
|
|
| Laboratories Pvt. Ltd., |
|
|
|
|
|
| 12-321, Opp. I.D.A, |
|
|
|
|
|
| Kurnool Road, |
|
|
|
|
|
| Pernamitta, Ongole – |
|
|
|
|
|
| 523 002, Andhra |
|
|
|
|
|
| Pradesh. |
|
|
|
| 13. | Phenytoin Sodium | B. No.: T-23953 | Description | Drug | RDTL |
|
| Tablets IP 100 mg | Mfg dt: 02/2021 |
| Control | Guwahati |
|
|
| Exp dt: 01/2023 |
| Department |
|
|
|
| Mfd by: M/s. Jackson |
| Meghalaya |
|
|
|
| Laboratories Pvt. Ltd., |
|
|
|
|
|
| 22-24, Majitha Road, Bye |
|
|
|
|
|
| Pass, Amritsar-143 001, |
|
|
|
|
|
| Punjab (India). |
|
|
|
| 14. | Levocetirizine | B. No.: LZR-2209 | pH | Drug | RDTL |
|
| Dihydrochloride | Mfg dt: 01/2022 |
| Control | Guwahati |
|
| Syrup 30 ml | Exp dt: 12/2023 |
| Department |
|
|
|
| Mfd by: M/s. Apple |
| Bihar |
|
|
|
| Formulations Pvt. Ltd., |
|
|
|
|
|
| Plot No. 208, Kishanpur, |
|
|
|
|
|
| Roorkee – 247 667, |
|
|
|
|
|
| Uttarakhand. |
|
|
|
| 15. | Levocetirizine Dihydrochloride Syrup 30 ml | B. No.: LZR-2207 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Apple Formulations Pvt. Ltd., Plot No. 208, Kishanpur, Roorkee – 247 667, Uttarakhand. | pH | Drug Control Department Bihar | RDTL Guwahati |
| 16. | Levocetirizine Dihydrochloride Syrup 30 ml | B. No.: LZR-2211 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Apple Formulations Pvt. Ltd., Plot No. 208, Kishanpur, Roorkee – 247 667, Uttarakhand. | pH | Drug Control Department Bihar | RDTL Guwahati |
| 17. | B-Complex Capsules | B. No.: UGC22130 Mfg dt: 06/2022 Exp dt: 11/2023 Mfd by: M/s. UNIMARCK HEALTHCARE LTD. Plot No. 24, 25 & 37, Sector 6A, SIDCUL, Haridwar-249403, Uttarakhand. | Description | Drug Control Department Bihar | RDTL Guwahati |
| 18. | RL-500 ml Compound Sodium Lactate Injection I.P. | B. No.: S2FBV07 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. SWAROOP Pharmaceuticals Pvt. Ltd., A-10, Tala Nagari, Industrial Area, Aligarh – 202 001, Uttar Pradesh. | Sterility and Bacterial Endotoxins | Drug Control Department Mizoram | RDTL Guwahati |
| 19. | B-Complex Capsules | B. No.: UGC22131 Mfg dt: 06/2022 Exp dt: 11/2023 Mfd by: M/s. UNIMARCK HEALTHCARE LTD. Plot No. 24, 25 & 37, Sector 6A, SIDCUL, Haridwar-249403 Uttarakhand. | Description | Drug Control Department Bihar | RDTL Guwahati |
| 20. | Erythromycin Stearate Tablets IP 250 mg (Erycon™-250) | B. No.: VGT11028 Mfg dt: 10/2021 Exp dt: 09/2024 Mfd by: M/s. Vobb Healthcare, Vill. Kishanpura, Baddi- Nalagarh Road, Baddi, Distt. Solan, Himachal Pradesh - 174 101. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
| 21. . | Amoxycillin 250 mg and Cloxacillin 250 mg Capsules | B. No.: 21BC012 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Maxmed Lifesciences Pvt. Ltd. Plot No-54, Sector-IIDC, SIDCUL, Rudrapur, Uttarakhand. | Description | Drug Control Department Meghalaya | RDTL Guwahati |
| 22. | Zinc Sulphate Oral Solution I.P., 100 ml | B. No.: ZCH-2209 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Apple Formulations Pvt. Ltd., Plot No. 208, Kishanpur, Roorkee – 247 667, Uttarakhand. | Weight per ml | Drug Control Department Bihar | RDTL Guwahati |
| 23. | KOOCAL-500 Tablets (Calcium with Vitamin D Tablets IP) | B. No.: TG21-2330 Mfg dt: 09/2021 Exp dt: 02/2023 Mfd by: M/s. Athens Life Sciences Mauza Rampur Jattan, Nahan Road, Kala Amb, Distt. Sirmour, Himachal Pradesh .- 173030. | Assay of Vitamin D3 | Drug Control Department Mizoram | RDTL Guwahati |
| 24. | KOOCAL-500 (Calcium with Vitamin D Tablets IP) | B. No.: TG21-2550 Mfg dt: 10/2021 Exp dt: 03/2023 Mfd by: M/s. Athens Life Sciences , Mauza Rampur Jattan, Nahan Road, Kala Amb, Distt. Sirmour, Himachal Pradesh -173030. | Assay of Vitamin D3 | Drug Control Department Mizoram | RDTL Guwahati |
|
|
| (A WHO - GMP CERTIFIED Company). |
|
|
|
| 25. | Zinc Sulphate | B. No.: LMT210773 | Disintegration | Drug | RDTL |
|
| Tablets 50 mg | Mfg dt: 08/2021 |
| Control | Guwahati |
|
| Zincload-50 | Exp dt: 07/2023 |
| Department |
|
|
|
| Mfd by: M/s. Life Max |
| Mizoram |
|
|
|
| Cancer Laboratories |
|
|
|
|
|
| Plot No. 106 & 106 A, |
|
|
|
|
|
| Sector-6A, IIE, |
|
|
|
|
|
| SIDCUL, Haridwar- |
|
|
|
|
|
| 249 403, Uttarakhand. |
|
|
|
| 26. | Neurace (Vitamin | B. No.: C00458 | Assay of | CDSCO | CDL |
|
| A, C, E & | Mfg dt: 07/2022 | Vitamin A | East Zone | Kolkata |
|
| Selenium | Exp dt: 12/2023 |
| Kolkata |
|
|
| Capsules ) | Mfd by: M/s. East West |
|
|
|
|
|
| Pharma (India) Pvt. Ltd., |
|
|
|
|
|
| Kh No. 196, Raipur |
|
|
|
|
|
| Industrial Area, |
|
|
|
|
|
| Bhagwanpur, Roorkee, |
|
|
|
|
|
| Dist. Haridwar, |
|
|
|
|
|
| Uttarakhand – 247 661, |
|
|
|
|
|
| India. |
|
|
|
| 27. | Hycorlin 100 mg | B. No.: DD2I002 | Clarity of Solution | CDSCO | CDL |
|
| (Hydrocortisone | Mfg dt: 09/2022 |
| East Zone | Kolkata |
|
| Sodium Succinate | Exp dt: 08/2024 |
| Kolkata |
|
|
| Injection IP) | Mfd by: M/s. Scott - Edil |
|
|
|
|
|
| Pharmecia Ltd., 56, |
|
|
|
|
|
| E.P.I.P. Phase I, |
|
|
|
|
|
| Jharmajri, Baddi Distt. |
|
|
|
|
|
| Solan – 173 205 (H.P.), |
|
|
|
|
|
| India. |
|
|
|
| 28. | ORLICA (Orlistat | B. No.: G22OEB001 | Dissolution | CDSCO | CDL |
|
| Capsules U.S.P. | Mfg dt: 06/2022 |
| East Zone | Kolkata |
|
| 120 mg) | Exp dt: 05/2024 |
| Kolkata |
|
|
|
| Mfd by: M/s. Acme |
|
|
|
|
|
| Generics Private Limited, |
|
|
|
|
|
| Plot No. 115, HPSIDC, |
|
|
|
|
|
| Industrial Area, Vill. |
|
|
|
|
|
| Davni, P.O. Gurumajra, |
|
|
|
|
|
| Tehsil Nalagarh, Distt. |
|
|
|
|
|
| Solan, Himachal |
|
|
|
|
|
| Pradesh, 174101, India. |
|
|
|
| 29. | Misoprostol Tablets I.P. 200 mcg | B. No.: RT220304 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Ridley Lifescience Pvt. Ltd., D- 1651, DSIDC, Indl. Complex, Narela, Delhi - 110 040. | Assay | CDSCO East Zone Kolkata | CDL Kolkata |
| 30. | SECROX (Cefuroxime Injection I.P. 1.5 gm), Sterile water for Injection I.P. 20 ml | B. No.: AB301008C Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Bengene Life Sciences Pvt. Ltd. Village Kishanpura, P.O. Manpura, Baddi - Nalagarh Road, Tehsil - Nalagarh, Distt. Solan, H.P. 174 101 (India). For WFI: B. No.: WM21E005, Mfg dt: 05/2021, Exp dt: 04/2024, Mfd by: M/s. Hindustan Polyfab, Plot No. 12, Ind Area, Davni Baddi, Himachal Pradesh – 173 205. | Particulate Matter | CDSCO South Zone Chennai | CDL Kolkata |
| 31. | SECROX (Cefuroxime Injection I.P. 1.5 gm), Sterile water for Injection I.P. 20 ml | B. No.: FAB302008 Mfg dt: 04/2022 Exp dt: 03/2024 Mfd by: M/s. Bengene Life Sciences Pvt. Ltd. Village Kishanpura, P.O. Manpura, Baddi - Nalagarh Road, Tehsil - Nalagarh, Distt. Solan, Himachal Pradesh - 174 101 (India). For WFI: B. No.: FW20-09, Mfg dt: 02/2022, Exp dt: 01/2027, Mfd by: M/s. Bhanu Healthcare Pvt. Ltd., | Particulate Matter | CDSCO South Zone Chennai | CDL Kolkata |
|
|
| V.P.O. Gurumajra, Nalagarh, Baddi, Solan, Himachal Pradesh – 173 205. |
|
|
|
| 32. | Romavit Capsules | B. No.: K21CS-63 | Description, Assay | CDSCO | CDL |
|
| (Amino Acids, | Mfg dt: 09/2021 | of Folic Acid, N- | South Zone | Kolkata |
|
| Biotin, Folic Acid, | Exp dt: 02/2023 | Acetyl Cysteine, | Chennai |
|
|
| Vitamins and | Mfd by: M/s. Kaizen | Ascorbic Acid |
|
|
|
| Minerals | Research Labs India Pvt. |
|
|
|
|
| Capsules) | Ltd., No. 705/5B, Old |
|
|
|
|
|
| Thiruthani Salai, |
|
|
|
|
|
| Melpudupettai, |
|
|
|
|
|
| Ananthalai Panchayat, |
|
|
|
|
|
| Walajapet T.K. Vellore, |
|
|
|
|
|
| District -632513, |
|
|
|
|
|
| Tamilnadu. |
|
|
|
| 33. | Romavit Capsules | B. No.: K22CS-36 | Description, Assay | CDSCO | CDL |
|
| (Amino Acids, | Mfg dt: 05/2022 | of N-Acetyl Cysteine | South Zone | Kolkata |
|
| Biotin, Folic Acid, | Exp dt: 10/2023 |
| Chennai |
|
|
| Vitamins and | Mfd by: M/s. Kaizen |
|
|
|
|
| Minerals | Research Labs India Pvt. |
|
|
|
|
| Capsules) | Ltd., No. 705/5B, Old |
|
|
|
|
|
| Thiruthani Salai, |
|
|
|
|
|
| Melpudupettai, |
|
|
|
|
|
| Ananthalai - Panchayat, |
|
|
|
|
|
| Walajapet T.K. Vellore, |
|
|
|
|
|
| District – 632 513, |
|
|
|
|
|
| Tamilnadu. |
|
|
|
| 34. | Cuprox-10 | B. No.: G-153/4014 | Dissolution | CDSCO | CDL |
|
| (Isoxsuprine | Mfg dt: 09/2021 |
| West Zone | Kolkata |
|
| Hydrochloride | Exp dt: 08/2023 |
| Mumbai |
|
|
| Tablets I.P. 10 mg) | Mfd by: M/s. Elfin Drugs |
|
|
|
|
|
| Pvt. Ltd., Vill. Berson, |
|
|
|
|
|
| Nalagarh, Himachal |
|
|
|
|
|
| Pradesh - 174 101. |
|
|
|
| 35. | Montelukast | B. No.: TE2027A | Description | CDSCO | CDL |
|
| Sodium and | Mfg dt: 05/2022 |
| West Zone | Kolkata |
|
| Levocetirizine | Exp dt: 04/2024 |
| Mumbai |
|
|
| Hydrochloride | Mfd by: M/s. Navkar |
|
|
|
|
| Tablets IP | Lifesciences, Plot No. 76, |
|
|
|
|
|
| Lodhi Majra, Industrial |
|
|
|
|
|
| Area, Baddi, Distt. Solan, |
|
|
|
|
|
| Himachal Pradesh. |
|
|
|
| 36. | Atorvastatin & Aspirin Capsules (10 / 75) | B. No.: AAC1010 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s. Vivimed Labs Limited, D-125 & 128, Phase III, I.D.A, Jeedimetla, Medchal - Malkajgiri District, Telangana State – 500 055. | Dissolution of Atorvastatin | CDSCO Sub-Zone Guwahati | CDL Kolkata |
| 37. | Budecort Respules 0.5 mg (Budesonide Nebuliser Suspension B.P.) | B. No.: IA20131 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Cipla Ltd., Plot 9 & 10, Indore SEZ Pithampur, Madhya Pradesh - 454 775, India | Assay | CDSCO Ahmedabad | CDL Kolkata |
| 38. | Montellion-10 (Montelukast Tablets IP 10 mg) | B. No.: T3092 Mfg dt: 10/2022 Exp dt: 09/2024 Mfd by: M/s. Stallion Laboratories Pvt. Ltd., C- 1B, 305/2, 3 4 & 5, G.I.D.C. Kerala (Bavla), Distt. Ahmeadbad - 382220, Gujarat. | Assay | CDSCO Ahmedabad | CDL Kolkata |
| 39. | Pan -D (Pantoprazole Gastro-Resistant and Domperidone Prolonged Release Capsules IP) | B. No.: 22442611 Mfg dt: 09/2022 Exp dt: 08/2024 Mfd by: M/s. Alkem Health Science, A unit of Alkem Laboratories Limited, Unit -2, Samardung, Karek Block, P.O. Namthang, South Sikkim – 737 137. | Identification and Assay | CDSCO East Zone Kolkata | CDL Kolkata |
| 40. | Pantocid DSR (Pantoprazole Gastro-Resistant and Domperidon Prolonged Release Capsules IP) | B. No.: SID0427A Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Sun Pharma Laboratories Ltd., Plot No. 107-108, Namli Block, P.O. Ranipool, East Sikkim 737 135. | Identification and Assay | CDSCO East Zone Kolkata | CDL Kolkata *Remark: The firm M/s. Sun Pharma, notified this office regarding availability of Spurious/ Counterfeit of the said batch of drug. |
|
|
|
|
|
| Accordingly samples were drawn during the raid. Further Investigation is under process. |
| 41. | Metronidazole Tablets IP 400 mg | B. No.: 3000521 Mfg dt: 03/2021 Exp dt: 02/2024 Mfd by: M/s. Karnataka Antibiotics and Pharmaceuticals Ltd., Plot No.14, II Phase, Peenya Industrial Area, Bengaluru-560058. | Dissolution | CDSCO Subzone Bangalore | CDTL Chennai |
| 42. | Apvaas 20 (Atorvastatin Calcium Tablets USP 20 mg) | B. No.: RE641 Mfg dt: 08/2022 Exp dt: 07/2025 Mfd by: M/s. Rivon Pharmaceuticals LLP, Plot No.33, Kamla Amrut Industrial Park, Indrad, Tal. Kadi, District : Mehsana, Gujarat. | Uniformity of weight | CDSCO Zonal Office Ahmedabad | CDTL Mumbai |
| 43. | Neorelax Gel (Diclofenac Gel I.P.) | B. No.: Q2203 Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. Curetech Skincare, Plot No. 33 & 34, Phase-IV, Bhatoli Kalan, Baddi, Dist. Solan, Himachal Pradesh - 173 205. | Related substances | CDSCO West-Zone Mumbai | CDTL Mumbai |
| 44. | Hydroxyzine HCl IP /BP | B. No.: 225004010 Mfg dt: 08/2022 Exp dt: 07/2027 Mfd by: M/s. Srikem Laboratories Pvt. Ltd., Plot 17/24, 17/23, 17/22, 17/13, MIDC Taloja- 410208, Taluka Panvel, Dist. Raigad, Maharashtra. | Appearance of solution | CDSCO West - Zone Mumbai | CDTL Mumbai |
| 45. | Hydroxyzine HCl IP /BP | B. No.: 225004015 Mfg dt: 09/2022 Exp dt: 08/2027 | Appearance of solution | CDSCO West - Zone Mumbai | CDTL Mumbai |
|
|
| Mfd by: M/s. Srikem Laboratories Pvt. Ltd., Plot 17/24, 17/23, 17/22, 17/13, MIDC Taloja- 410208, Taluka Panvel, Dist. Raigad., Maharashtra. |
|
|
|
| 46. | Hydroxyzine HCl IP /BP | B. No.: 225004009 Mfg dt: 08/2022 Exp dt: 07/2027 Mfd by: M/s. Srikem Laboratories Pvt. Ltd., Plot 17/24, 17/23, 17/22, 17/13, MIDC Taloja- 410208, Taluka Panvel, Dist. Raigad. Maharashtra. | Appearance of solution | CDSCO West - Zone Mumbai | CDTL Mumbai |
| 47. | Hydroxyzine HCl IP /BP | B. No.: 225004011 Mfg dt: 08/2022 Exp dt: 07/2027 Mfd by: M/s. Srikem Laboratories Pvt. Ltd., Plot 17/24, 17/23, 17/22, 17/13, MIDC Taloja- 410208, Taluka Panvel, Dist. Raigad. Maharashtra. | Appearance of solution | CDSCO West - Zone Mumbai | CDTL Mumbai |
| 48. | Hydroxyzine HCl IP /BP | B. No.: 225004007 Mfg dt: 07/2022 Exp dt: 06/2027 Mfd by: M/s. Srikem Laboratories Pvt. Ltd., Plot 17/24, 17/23, 17/22, 17/13, MIDC Taloja- 410208, Taluka Panvel, Dist. Raigad. Maharashtra. | Appearance of solution | CDSCO West - Zone Mumbai | CDTL Mumbai |
| 49. | Chymnetra-Forte (Trypsin- Chymotrypsin Tablets) | B. No.: TTP-22017 Mfg dt: 02/2022 Exp dt: 01/2025 Mfd by: M/s. D.R. Johns Lab Pvt. Ltd – Plot No.3, Sector 6A, IIE, SIDCUL, Haridwar- 249403, | Disintegration time and Assay | CDSCO West - Zone Mumbai | CDTL Mumbai |
|
|
| Uttarakhand. |
|
|
|
| 50. | INDIFIBER (Fenofibrate Capsules I.P.) | B. No.: 6078 Mfg dt: 04/2022 Exp dt: 03/2024 Mfd by: M/s. INDILINA PHARMACEUTICALS, Hambran Road, Jainpur, Ludhiana- 142027, Punjab. | Dissolution | CDSCO West - Zone Mumbai | CDTL Mumbai |
| 51. | Teneligliptin Tablets I.P. 20mg (ZITEN) | B. No.: 18220490 Mfg dt: 07/2022 Exp dt: 06.2024 Mfd by: M/s. Glenmark Pharmaceuticals Ltd.,Samlik Marchak, Industrial Growth Centre, East Sikkim, Sikkim- 737135 | Dissolution | CDSCO Zonal Office Hyderabad | CDTL Hyderabad |
| 52. | Adhesive Tape USP (Micropore Surgical Tape) | B. No.: R03200508 Mfg dt: 03/2020 Exp dt: 02/2025 Mfd by: M/s. 3M India Limited, B-20, MIDC – Ranjangaon, Tal. Shirur, Pune, Maharashtra- 412 220. | Tensile strength per 2.54 cm of width | Drug Control Department Gujarat | RDTL Chandigarh |
| 53. | Alpha Lipoic Acid, Folic Acid, Mecobalamin Pyridoxine, Viatmin D3 Tablet (NILCOBAL-D TABLETS) | B. No.: RP1T63 Mfg dt: 06/2022 Exp dt: 05/2023 Mfd by: M/s. Relieve Pharmaceuticals, Khasra No. 2032/2, Vill. Chandpur The. Haroli, Una, Himachal Pradesh. | Identification and Assay of Alpha Lipoic Acid, Folic Acid, Mecobalamin, Vitamin D3 and the Assay of Pyridoxine Hydrochloride | Drug Control Department Delhi | RDTL Chandigarh |
| 54. | Trypsin- Chymotrypsin Tablets (CHYMORAL FORTE TABLETS) | B. No.: 2JH3H019 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. TORRENT PHARMACEUTICLS LTD., 32 No. Middle Camp, NH-10, East District, Gangtok, Sikkim- 737 135. | Disintegration test (Acid Medium) | Drug Control Department Delhi | RDTL Chandigarh |
|
|
|
|
|
|
|
| 55. | Cloxacillin Sodium Capsules IP 500 mg | B. No.: RC220021 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Ridley Life Science Pvt Ltd., D-1651, DSIDC Indl Complex, Narela, Delhi - 110040. | Assay of Cloxacillin Sodium calculated as Cloxacillin | Drug Control Department Delhi | RDTL Chandigarh |
| 56. | Prednisolone Tablets IP 5 mg | B. No.: DTB-130 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. DAFFODILLS PHARMACEUTICALS LTD., Jawahar Nagar, Rohta Road, Meerut - 250 001, Uttar Pradesh (INDIA). | Related Substances | CDSCO North Zone Ghaziabad | RDTL Chandigarh |
| 57. | Voglibose Tablets IP (0.2 mg) | B. No.: TV-880012 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Centurion Remedies Pvt. Ltd., G/5 and G/6 industrial Estate Gorwa, Vadodara- 390016, Gujarat. | Disintegration | CDSCO North Zone Ghaziabad | RDTL Chandigarh |
| 58. | Peritoneal Dialysis Solution IP with 1.5% w/v Dextrose | B. No.: PD2206101 Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. Mitra Industries (P) Ltd., 14/4, Delhi-Mathura Road, Faridabad-121 003, Haryana, India. | Assay of Calcium Magnesium and Lactate | CDSCO North Zone Ghaziabad | RDTL Chandigarh |
| 59. | Frusemide Tablets IP 40 mg | B. No.: FXTZ-08 Mfg dt: 08/2022 Exp dt: 07/2024 Mfd by: M/s. Nestor Pharmaceuticals, Limited, 11, Western, Extension Area, Faridabad- 121 001, Haryana, India. | Uniformity of weight and Dissolution test | CDSCO North Zone Ghaziabad | RDTL Chandigarh |
| 60. | Peritoneal Dialysis Solution IP with 2.5% w/v Dextrose | B. No.: PD2206098 Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. Mitra Industries (P) Ltd., 14/4, Delhi-Mathura Road, Faridabad-121 003, Haryana, India. | Assay of Calcium, Magnesium and Lactate | CDSCO North Zone Ghaziabad | RDTL Chandigarh |
| 61. | Aceclofenac 100 mg & Thiocolchicoside 4 mg Tablets (Zerodol TH 4 Tablets) | B. No.: FXT011022AS Mfg dt: 12/2021 Exp dt: 11/2024 Mfd by: M/s. Ipca Laboratories Ltd., 393/394, Melli Jorethang Road, Gom Block, Bharikhola, South District, Sikkim-737 121. | Identification and Assay of Thiocolchicoside | Drug Control Department Himarchal Pradesh | RDTL Chandigarh |
| 62. | Aceclofenac 100 mg & Thiocolchicoside 4 mg Tablets (Zerodol TH 4 Tablets) | B. No.: FXT012008AS Mfg dt: 03/2022 Exp dt: 02/2025 Mfd by: M/s. Ipca Laboratories Ltd., 393/394, Melli Jorethang Road, Gom Block, Bharikhola, South District, Sikkim-737 121. | Identification and Assay of Thiocolchicoside | Drug Control Department Himarchal Pradesh | RDTL Chandigarh |
| 63. | Loose yellow colored Tablets (Purported to contain Rosuvastatin 10 mg) | B. No.: Not Mentioned Mfg dt: null Exp dt: null Mfd by: Manufactured in the premises of firm M/s Trizal Formulation, Plot No. 29, HPSIDC, Industrial Area, Distt. Solan, Himachal Pradesh. | Assay of Rosuvastatin | Drug Control Department Himarchal Pradesh | RDTL Chandigarh |
| 64. | Loose Powder (Purported to be contain Telmisartan) | B. No.: Not Mentioned Mfg dt: null Exp dt: null Mfd by: Not Mentioned, NM. | Identification of Telmisartan | Drug Control Department Himarchal Pradesh | RDTL Chandigarh |
| 65. | Aceclofenac and Thiocolchicoside Tablets (Acetan- TH Tablets) | B. No.: RT-190622 Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. Renowed Life Sciences, HACCP & ISO 9001:2015 Certified Co. Plot No.12, Sector-6B, SIDCUL, Haridwar-249403, Uttarakhand (INDIA). | Assay of Aceclofenac | Drug Control Department Himarchal Pradesh | RDTL Chandigarh |
| 66. | Levocetirizine Hydrochloride Tablets IP (Levocetirizine Tablets) | B. No.: AF-22T619 Mfg dt: 08/2022 Exp dt: 07/2024 Mfd by: M/s. Affine Formulations Ltd., 1947/3, Vill. Bhatian, Tehsil Nalagarh, Distt. Solan 174101, Himachal Pradesh, India. | Dissolution | CDSCO North Zone Ghaziabad | RDTL Chandigarh |
| 67. | Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (GlimiSave M2 Tablets) | B. No.: GGLV22007 Mfg dt: 03/2022 Exp dt: 02/2025 Mfd by: M/s. Eris Lifesciences Limited, Amingaon, North Guwahati, Dist. Kamrup - (Assam) 781031. | Dissolution | Drug Control Department Himachal Pradesh | RDTL Chandigarh |
