CDSCO Drug Alert: 70 drug samples including GSK Betnovate C cream, Cipla's Junior Lanzol mentioned in the list
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 70 medicine batches for failing to qualify for a random drug sample test for the month of December– 2022.
These drug samples include Glimepiride Tablets I.P. 1mg manufactured by T & G Medicare, Levocetirizine Dihydrochloride Syrup manufactured by Apple Formulations, Atenolol & Amlodipine Tablets I.P. 50mg/5mg manufactured by Zee Laboratories, Paracetamol Tablets I.P. 500 mg manufactured by Orissa Drugs & Chemicals, Telmistad – 40 (Telmisartan Tablets IP 40 mg) manufactured by Statmed Private Limited and others.
In addition to this, the name of Betamethasone and Clioquinol Cream (BETNOVATE-C SKIN CREAM) manufactured by GlaxoSmithKline Pharmaceuticals is also on the list of samples declared as Not of Standard Quality due to failure of Identification test and Assay of Betamethasone Valerate calculated as Betamethasone and Clioquinol. Having said that, the alert also carries a remark noting that on response to the aforementioned alert, pharmaceutical giant GlaxoSmithKline Pharmaceuticals has informed the CDSCO office about the availability of spurious/counterfeit versions of the specified batch of medication. "Investigation is under process," the CDSCO added to its note.
Furthermore, the list includes Junior Lanzol 15 mg (Lansoprazole Orally Disintegrating Tablets 15 mg) manufactured by Cipla and Sodium Valproate Tablets I.P. 200 mg manufactured by Bharat Parenterals.
The list came after analysis and test were conducted by the CDSCO, Drugs Control Departments on 1375 samples. Out of this, 1305 samples were found of standard quality while 70 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 sterility 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 December– 2022
Total number of samples tested | 1375 |
Total number of samples declared as of Standard Quality | 1305 |
Total number of samples declared as Not of Standard Quality | 70 |
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. | OFLOWIND-OZ (Ofloxacin & Ornidazole Tablets IP) | B. No.: G-T388 Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s. Globin Pharmaceuticals Pvt. Ltd., Puhana Chowk, Dehradun Road, Roorkee, Dist. Haridwar Uttarakhand - 247667. | Dissolution “(Ofloxacin and Ornidazole)” | Drug Control Department Bihar | RDTL Guwahati |
2. | VOVEZAL-3 (Diclofenac Sodium Injection I.P.) | B. No.: GI-049 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s. Globin Pharmaceuticals Pvt. Ltd. Puhana Chowk, Dehradun Rd, Roorkee, Uttarakhand. | pH and Assay Content of Diclofenac Sodium | Drug Control Department Assam | RDTL Guwahati |
3. | Glimepiride Tablets I.P. 1mg | B. No.: TGT12213097 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. T & G Medicare, Village Kunjahal PO Baddi, Distt. Solan, Himachal Pradesh. | Dissolution | Drug Control Department Nagaland | RDTL Guwahati |
4. | KOOCAL-500 Tablets (Calcium with Vitamin D Tablets IP) | B. No.: TG21-2346 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 | Identification and Assay of “Vitamin D3” | Drug Control Department Mizoram | RDTL Guwahati |
5. | Calcium with Vitamin D Tablets IP KOOCAL-500 | B. No.: TG21-2539 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. | “Identification and Assay/Content of Vitamin D3” | Drug Control Department Mizoram | RDTL Guwahati |
6. | Levocetirizine Dihydrochloride Syrup | B. No.: LZR-2204 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Apple Formulations Pvt. Ltd. Plot No. 208, Kishanpur, Roorkee-247667 Uttarakhand. | pH | Drug Control Department Bihar | RDTL Guwahati |
7. | Calcium and Vitamin D3 Tablets IP (CALBICIN-D FORTE Tablets) | B. No.: TGT12213182 Mfg dt: 12/2021 Exp dt: 06/2023 Mfd by: M/s. T & G Medicare, Village Kunjahal, PO Baddi, Distt. Solan, Himachal Pradesh. | Identification as well as Assay of “Vitamin D3” | Drug Control Department Nagaland | RDTL Guwahati |
8. | Atenolol & Amlodipine Tablets I.P. 50mg/5mg | B. No.: Z22-013 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Zee Laboratories Ltd. Behind 47, Industrial Area, Paonta Sahib- 173025, Himachal Pradesh. | Dissolution (Amlodipine) and Assay/Content of Amlodipine | Drug Control Department Bihar | RDTL Guwahati |
9. | KOOCAL-500 Tablets (Calcium with Vitamin D Tablets IP) | B. No.: TG21-2565 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 – 173 030 | Assay of “Vitamin D3” | Drug Control Department Mizoram | RDTL Guwahati |
10. | Lomolok (Loperamide Hydrochloride Tablets I.P.) | B. No.: T8842 Mfg dt: 07/2021 Exp dt: 06/2024 Mfd by: M/s. Quest Laboratories Pvt. Ltd., Plot No.-45, Sector-III, Indl. Area, Pithampur, Distt. Dhar-454775, Madhya Pradesh. | Assay | Drug Control Department Assam | RDTL Guwahati |
11. | CIPROFLOXACIN 250 (CIPROFLOXACIN HYDROCHLORIDE TABLETS I.P. 250 mg) | B. No.: 0600822 Mfg dt: 05/2022 Exp dt: 04/2025 Mfd by: M/s. KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LIMITED, Plot No. 14, II Phase, Peenya, Bengaluru – 560 058. | Dissolution | Drug Control Department Jharkhand | RDTL Guwahati |
12. | Omirid-10 (Omeprazole Capsules IP) | B. No.: OMI-2101 Mfg dt: APR.2021 Exp dt: MAR.2023 Mfd by: M/s. RIDLEY LIFE SCIENCE PVT. LTD., D-1651, DSIDC Indl. Complex, Narela, Delhi -110 040. | Dissolution | Drug Control Department Meghalaya | RDTL Guwahati |
13. | Rabeprazole Gastro Resistant Tablets IP 20 mg | B. No.: RRZT-016 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. | Dissolution (Buffer stage), Assay of Rabeprazole Sodium and Description | Drug Control Department Bihar | RDTL Guwahati |
14. | Iron & Folic Acid Syrup IP, 50 ml | B. No.: AHL21034 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. ALVES HEALTHCARE PRIVATE LIMITED, Nangal Uparla, Swarghat Road, Nalagarh, Dist. Solan- 174 101, Himachal Pradesh, INDIA | ‘pH’ and ‘Identification & Assay of Folic Acid’ | Drug Control Department Jharkhand | RDTL Guwahati |
15. | Calcium with Vitamin D Tablets IP KOOCAL-500 | B. No.: TG21-2564 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 – 173 030 | “Identification and Assay of Vitamin D3” | Drug Control Department Mizoram | RDTL Guwahati |
16. | Iron & Folic Acid Syrup IP, 50 ml. | B. No.: AHL21015 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. Alves Healthcare Private Limited, Nangal Uparla,a, Swarghat Road, Nalagarh, Dist. Solan- 174 101 Himachal Pradesh, India. | “pH” and Identification & Assay of “Folic Acid” | Drug Control Department Jharkhand | RDTL Guwahati |
17. | Levocetirizine Dihydrochloride Syrup | B. No.: LZR-2208 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Apple Formulations Pvt. Ltd. Plot No. 204, Kishanpur, Roorkee-247667 (U.K.). | ‘pH’ | Drug Control Department Bihar | RDTL Guwahati |
18. | Iron & Folic Acid Syrup IP (50 ml) | B. No.: AHL21012 Mfg dt: 05/2021 Exp dt: 04/2023 Mfd by: M/s. ALVES HEALTHCARE PRIVATE LIMITED, Nangal Uparla, Swarghat Road, Nalagarh, Distt. Solan- 174 101 Himachal Pradesh, INDIA. | ‘pH’, Identification & Assay of ‘Folic Acid’ | Drug Control Department Jharkhand | RDTL Guwahati |
19. | GALPARA SUSPENSION (PARACETAMOL PAEDIATRIC ORAL SUSPENSION IP), 60m | B. No.: LGL-22157 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Prochem Pharmaceuticals Pvt. Ltd., 140-141, Makkanpur Bhagwanpur, Roorkee, Dist Haridwar-247661 Uttarakhand, India. | Assay of Paracetamol | Drug Control Department Meghalaya | RDTL Guwahati |
20. | GALPARA SUSPENSION (Paracetamol Paediatric Oral Suspension I.P.) | B. No.: LGL-22157 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Prochem Pharmaceuticals Pvt. Ltd., 140-141, Makkanpur Bhagwanpur, Roorkee, Dist Haridwar-247661 Uttarakhand India. | Assay of Paracetamol | Drug Control Department Meghalaya | RDTL Guwahati |
21. . | Levocetirizine Dihydrochloride Syrup, 30ml | B. No.: LZR-2204 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Apple Formulations Pvt. Ltd. Plot No. 208, Kishanpur, Roorkee-247667 Uttarakhand. | pH | Drug Control Department Bihar | RDTL Guwahati |
22. | Cifazime-AZ (Cefixime & Azithromycin Tablets) | B. No.: CZT-2101 Mfg dt: 02/2021 Exp dt: 01/2023 Mfd by: M/s. Fantasy Drugs Private Limited C-66 to 69, Industrial Area, Hajipur-844101, Bihar (India). | Identification of Azithromycin & Assay of Cefixime & Azithromycin | Drug Control Department Bihar | RDTL Guwahati |
23. | DSP (Diclofenac Potassium Serratiopeptidase & Paracetamol Tablets) | B. No.: LSAT-016 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. LABORATE PHARMACEUTICALS INDIA LTD, (Unit-II) #31, Rajban Road, Nariwala Paonta Sahib, Himachal Pradesh | Description | Drug Control Department Jharkhand | RDTL Guwahati |
24. | Co-trimoxazole Tablets IP SS | B. No.: CM-122 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. High Tech Pharma, 49, Khandelwal Compound, Plada, Indore Madhya Pradesh. | Disintegration | Drug Control Department Jharkhand | RDTL Guwahati |
25. | Moxiion-CV Dry Syrup (Amoxycillin & Potassium Clavulanate Oral Suspension), 3.3gm/30ml. with water | B. No.: WJD-092C Mfg dt: 08/2021 Exp dt: 01/2023 Mfd by: M/s. WELCURE REMEDIES Nahan Road, Vill Moginand, Distt. Sirmour - 173030 Himachal Pradesh. | Assay/ Content’ of Clavulanic Acid | Drug Control Department Jharkhand | RDTL Guwahati |
26. | Amikacin Injection IP | B. No.: 21 AM02 Mfg dt: 03/2021 Exp dt: 02/2023 Mfd by: M/s. Sai Parenterals Pvt. Ltd., D4, Phase V, IDA, Jeedimetla, Hyderabad – 500055. | Description & Particulate Matter | Drug Control Department Andhra Pradesh | CDL Kolkata |
27. | Sodium Valproate Tablets I.P. 200 mg | B. No.: T2282 Mfg dt: 08/2022 Exp dt: 07/2024 Mfd by: M/s. Bharat Parenterals Ltd., Survey No. 144 & 146, Jarod Samlaya Road Tal. Savli City, Haripura, Vadodara, Gujarat – 391 520. | Related Substances | CDSCO Zonal Office Ahmedabad | CDL Kolkata |
28. | Sodium Valproate Tablets I.P. 200 mg | B. No.: T2283 Mfg dt: 08/2022 Exp dt: 07/2024 Mfd by: M/s. Bharat Parenterals Ltd., Survey No. 144 & 146, Jarod Samlaya Road Tal. Savli City, Haripura, Vadodara, Gujarat – 391 520. | Related Substances | CDSCO Zonal Office Ahmedabad | CDL Kolkata |
29. | Paracetamol Tablets I.P. 500 mg | B. No.: 9717 Mfg dt: 03/2021 Exp dt: 02/2024 Mfd by: M/s. Orissa Drugs & Chemicals Limited, 1, Mancheswar Industrial Estate, Bhubaneswar (Odisha). | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
30. | RamiRav Tablets (Ramipril Tablets I.P. 1.25 mg) | B. No.: NKT22116A Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. Nexkem Biotech Pvt. Ltd., Plot No. 64, HPSIDC, Industrial Area, Baddi, Distt. Solan Himachal Pradesh – 173 205. | Dissolution & Assay | CDSCO East Zone Kolkata | CDL Kolkata |
31. | Ridtas – S (S(-)Amlodipine Tablets I.P.) | B. No.: RT220619 Mfg dt: 08/2022 Exp dt: 07/2024 Mfd by: M/s. Ridley Life Sciences Pvt. Ltd., D- 1651, DSIDC, Indl. Complex, Narela, Delhi – 110040. | Dissolution & Assay | CDSCO East Zone Kolkata | CDL Kolkata |
32. | Fenosky - 200 (Fenofibrate Tablets I.P. 200 mg) | B. No.: T220209 Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s. Medisky Pharmaceuticals, Plot No. 260, GIDC, Talod – 383215, Dist. Sabarkantha (Gujarat). | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
33. | Prednisolone Tablets I.P. 5 mg | B. No.: PNT5-22-221 Mfg dt: 04/2022 Exp dt: 03/2024 Mfd by: M/s. Ornate Labs Pvt. Ltd., Bela Industrial Estate, Muzaffarpur-842005. Bihar. | Description | CDSCO East Zone Kolkata | CDL Kolkata |
34. | Prednisolone Tablets I.P. 10 mg | B. No.: PNT10-22-221 Mfg dt: 04/2022 Exp dt: 03/2024 Mfd by: M/s. Ornate Labs Pvt. Ltd., Bela Industrial Estate, Muzaffarpur-842005, Bihar. | Description | CDSCO East Zone Kolkata | CDL Kolkata |
35. | Atorvadoc 20 (Atorvastatin Tablets I.P. 20 mg) | B. No.: MFT720 Mfg dt: 06/2022 Exp dt: 05/2024 Mfd by: M/s. Amster Labs, Unit-II, Hilltop, Ind. Estate, Vill. Bhatauli Kalan, Baddi, Distt. Solan Himachal Pradesh. | Dissolution | CDSCO East Zone Kolkata | CDL Kolkata |
36. | Telmistad – 40 (Telmisartan Tablets IP 40 mg) | B. No.: C23D7 Mfg dt: 07/2022 Exp dt: 06/2024 Mfd by: M/s. Statmed Private Limited, 15, Jawpore Road, Kolkata – 700074. | Description | CDSCO East Zone Kolkata | CDL Kolkata |
37. | Astyfer XT (Ferrous Ascorbate with Aminoacids, Zinc and Vitamins Tablet I.P.) | B. No.: TTQ2P5 Mfg dt: 08/2022 Exp dt: 07/2024 Mfd by: M/s. Tablets (India) Limited, 179, T.H. Road, Chennai – 600 081. | Disintegration | CDSCO Sub-Zone Guwahati | CDL Kolkata |
38. | MYLOMAX (Methylcobalamin, Alpha Lipoic Acid, Folic Acid, Pyridoxine Hydrochloride & Vitamin D3 Tablets) | B. No.: R2295307G Mfg dt: 07/2022 Exp dt: 12/2023 Mfd by: M/s. Reltsen Health Care, Spl. Plot No. 9-11, PIPDIC Electronic Park, Thirubuvanai, Puducherry – 605 107. | Assay of Alpha Lipoic Acid | CDSCO South Zone Chennai | CDL Kolkata |
39. | MECOBROOK-AT (Methylcobalamin, Alpha Lipoic Acid, Folic Acid, Pyridoxine Hydrochloride & Vitamin D3 Tablets) | B. No.: T2205148 Mfg dt: 05/2022 Exp dt: 04/2024 Mfd by: M/s. Healing Pharma India Pvt. Ltd., Mfg At. 81/10, GIDC, Near Vadsar Bridge, Makarpura, Vadodara - 10, Gujarat. | Disintegration, Assay of Alpha Lipoic Acid & Vitamin D3 | CDSCO South Zone Chennai | CDL Kolkata |
40. | Paracetamol Tablets I.P. 500 mg | B. No.: 220124 Mfg dt: 01/2022 Exp dt: 12/2024 Mfd by: M/s. Modi Antibiotics, Plot No. 28, G.I.D.C., Ahmedabad 382 415, Gujarat. | Dissolution | CDSCO West Zone Mumbai | CDL Kolkata |
41. | CSP (Cough Syrup for Throat & Chesty Coughs) 100 ml | B. No.: LOCG21-85 Mfg dt: 08/2021 Exp dt: 07/2024 Mfd by: M/s. Maiden Pharmaceuticals, Village Manpura, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh, Nalagarh – 174101. | Assay of Diphenhydramine Hydrochloride, Codeine Phosphate, Sodium Citrate & Menthol | Drug Control Department Himachal Pradesh | CDL Kolkata |
42. | CSP (Cough Syrup for Throat & Chesty Coughs) 100 ml | B. No.: LOCG21-94 Mfg dt: 08/2021 Exp dt: 07/2024 Mfd by: M/s. Maiden Pharmaceuticals, Village Manpura, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh, Nalagarh – 174101. | Assay of Diphenhydramine Hydrochloride, Codeine Phosphate, Sodium Citrate & Menthol | Drug Control Department Himachal Pradesh | CDL Kolkata |
43. | CSP (Cough Syrup for Throat & Chesty Coughs) 100 ml | B. No.: LOCG21-95 Mfg dt: 08/2021 Exp dt: 07/2024 Mfd by: M/s. Maiden Pharmaceuticals, Village Manpura, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh, Nalagarh – 174101. | Assay of Diphenhydramine Hydrochloride, Codeine Phosphate, Sodium Citrate & Menthol | Drug Control Department Himachal Pradesh | CDL Kolkata |
44. | CSP (Cough Syrup for Throat & Chesty Coughs) 100 ml | B. No.: LOCG21-84 Mfg dt: 08/2021 Exp dt: 07/2024 Mfd by: M/s. Maiden Pharmaceuticals, Village Manpura, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh, Nalagarh – 174101. | Assay of Codeine Phosphate & Menthol | Drug Control Department Himachal Pradesh | CDL Kolkata |
45. | CSP (Cough Syrup for Throat & Chesty Coughs) 100 ml | B. No.: LOCG21-96 Mfg dt: 08/2021 Exp dt: 07/2024 Mfd by: M/s. Maiden Pharmaceuticals, Village Manpura, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh, Nalagarh – 174101. | Assay of Codeine Phosphate, Sodium Citrate & Menthol | Drug Control Department Himachal Pradesh | CDL Kolkata |
46. | Orthorium - MSM (Diacerein, Glucosamine Sulphate & Methyl Sulfonyl Methane Tablets) | B. No.: Not Mentioned Mfg dt: Not Mentioned, Exp dt: Not Mentioned Mfd by: M/s. L.V. Life Sciences, VPO, Gurumajra, Baddi, Distt. Solan Himachal Pradesh – 174 101. | Description and Misbranded | Drug Control Department Himachal Pradesh | CDL Kolkata |
47. | RL 500 ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection I.P.) | B. No.: S2FBV28 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 & Sterility | Drug Control Department Odisha | CDL Kolkata |
48. | RL 500 ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection I.P.) | B. No.: 203124 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Ives Drugs (India) Pvt. Ltd., Works: Ghatabillod, Distt. Dhar H.O. 504, Chetak Center, R.N.T. Marg, Indore -1 (India). | Bacterial Endotoxins & Sterility | Drug Control Department Odisha | CDL Kolkata |
49. | RL 500 ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection I.P.) | B. No.: 203121 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Ives Drugs (India) Pvt. Ltd., Works: Ghatabillod, Distt. Dhar. H.O. 504, Chetak Center, R.N.T. Marg, Indore -1 (India). | Sterility | Drug Control Department Odisha | CDL Kolkata |
50. | RL 500 ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection I.P.) | B. No.: 110051 Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. Ives Drugs (India) Pvt. Ltd., Works: Ghatabillod, Distt. Dhar H.O. 504, Chetak Center, R.N.T. Marg, Indore -1 (India). | Description, Particulate Contamination & Sterility | Drug Control Department Odisha | CDL Kolkata |
51. | RL 500 ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection I.P.) | B. No.: 204002 Mfg dt: 04/2022 Exp dt: 03/2024 Mfd by: M/s. Ives Drugs (India) Pvt. Ltd., Works: Ghatabillod, Distt. Dhar H.O. 504, Chetak Center, R.N.T. Marg, Indore -1 (India). | Sterility | Drug Control Department Odisha | CDL Kolkata |
52. | RL 500 ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Inj.) | B. No.: S2FBV20 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 |
53. | RL 500 ml, Compound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection I.P.) | B. No.: 203119 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Ives Drugs (India) Pvt. Ltd., Works: Ghatabillod, Distt. Dhar H.O. 504, Chetak Center, R.N.T. Marg, Indore -1 (India). | Particulate Contamination & Sterility | Drug Control Department Odisha | CDL Kolkata |
54. | RL 500 ml, Compound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection I.P.) | B. No.: 112085 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Ives Drugs (India) Pvt. Ltd., Works: Ghatabillod, Distt. Dhar H.O. 504, Chetak Center, R.N.T. Marg, Indore -1 (India). | Sterility | Drug Control Department Odisha | CDL Kolkata |
55. | RL 500 ml, Compound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection I.P.) | B. No.: 203047 Mfg dt: 03/2022 Exp dt: 02/2024 Mfd by: M/s. Ives Drugs (India) Pvt. Ltd., Works: Ghatabillod, Distt. Dhar H.O. 504, Chetak Center, R.N.T. Marg, Indore -1 (India). | Sterility | Drug Control Department Cuttack | CDL Kolkata |
56. | RL 500 ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Injection) | B. No.: S2FBV38 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 Cuttack | CDL Kolkata |
57. | Ampholis Injection – 10 ml (Amphotericin B Emulsion Injection) | B. No.: SI-515 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Shivam Enterprises, Suketi Road, Kala-Amb, Distt. Sirmour Himachal Pradesh – 173 030. | pH, Bacterial endotoxins and Sterility | Drug Control Department Rajasthan | CDL Kolkata |
58. | Zinc Sulphate Dispersible Tablets IP 20 mg | B. No.: ZST903 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Unicure India Ltd.,C-21, 22 & 23, Sector -3, Noida – 201301, Distt. Gautam Budh Nagar, Uttar Pradesh. | Assay | CDSCO Subzone Bangalore | CDTL Chennai |
59. | 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, Bengaluru- 560058. | Dissolution | CDSCO Subzone Bangalore | CDTL Chennai |
60. | Junior Lanzol 15 mg (Lansoprazole Orally Disintegrating Tablets 15 mg) | B. No.: BA12571 Mfg dt: 08/2021 Exp dt: 07/2023 Mfd by: M/s. Cipla Ltd., Malpur, Dist. Solan 173205, Himachal Pradesh. | Hardness | CDSCO Sub-Zone Indore | CDTL Mumbai |
61. | Decmax 4 mg (Dexmethasone Tablets IP 4 mg) | B. No.: ST-21286 Mfg dt: 06/2021 Exp dt: 05/2024 Mfd by: M/s. Supermax Drugs & Pharmaceutical Pvt. Ltd., (Unit-II, Khasra No. 322, Nanheda Anantpur, Bhagwanpur, Roorkee- 247668, Haridwar, Uttarakhand. | Related substances. | CDSCO West- Zone Mumbai | CDTL Mumbai |
62. | FERROUS ASCORBATE & FOLIC ACID CAPSULES | B. No.: 1013 Mfg dt: 12/2021 Exp dt: 11/2023 Mfd by: M/s. Vivimed Labs Limited, D-125 & 128, Phase III, I.D.A., Jeedimetla, Medchal- Malkajgiri (Dist) Telangana State- 500055. | AVERAGE FILL AND ASSAY FOLIC ACID | CDSCO Zonal office Hyderabad | CDTL Hyderabad |
63. | Ceftriaxone and Sulbactam for Injection (Metifex SL 1500 Injection) | B. No.: 322-797 Mfg dt: 08/2022 Exp dt: 07/2024 Mfd by: M/s. Zee Laboratories Limited Behind 47, Industrial Area, Paonta Sahib- 173205, Himachal Pradesh. | Identification of Ceftriaxone Sodium and Sulbcatam Sodium, pH and Assay of Ceftriaxone Sodium calculated as Ceftriaxone and Sulbactam Sodium calculated as Sulbactam | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
64. | Ramipril Tablets IP (Ramichek 5 Tablets) | B. No.: MT214919 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s. Mascot Health Series Pvt. Ltd., Plot No. 79,80, Sector- 6A, IIE, Sidcul, Haridwar-249403, Uttarakhand. | Assay and Dissolution of Ramipril Tablets IP (Ramichek 5 Tablets) | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
65. | Paediatric Paracetamol Oral Suspension BP (PARA 120 SUSPENSION) | B. No.: D10086 Mfg dt: 10/2021 Exp dt: 09/2024 Mfd by: M/s. DM PHARMA PVT. LTD., Vill-Bhud, NH-21A, Baddi, Distt - Solan, Himachal Pradesh- 173205, INDIA. | Related Substances and Assay of Paracetamol | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
66. | Paediatric Paracetamol Oral Suspension BP (PARA 120 SUSPENSION) | B. No.: D10085 Mfg dt: 10/2021 Exp dt: 09/2024 Mfd by: M/s. DM PHARMA PVT. LTD., Vill-Bhud, NH-21A, Baddi, Distt-Solan, Himachal Pradesh - 173205, INDIA. | Related Substances and Assay of Paracetamol | CDSCO Sub-Zone Baddi | RDTL Chandigarh |
67. | Betamethasone and Clioquinol Cream BP (BETNOVATE-C SKIN CREAM) | B. No.: NH1118 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s. GlaxoSmithKline Pharmaceuticals Limited, At. A-10, M.I.D.C., Ambad- Pathardi Block, Nashik 422010, Maharashtra, INDIA. | Identification (A), (B), (C) and Assay of Betamethasone Valerate calculated as Betamethasone and Clioquinol | Drug Control Department Delhi | RDTL Chandigarh *Remark: The firm M/s. GSK notified this office regarding availability of Spurious/ Counterfeit of the said batch of drug. Investigation is under process. |
68. | Telmisartan and Hydrochlorothiazide Tablets IP (SARTAN-H TABLETS) | B. No.: 012259 Mfg dt: 01/2022 Exp dt: 12/2023 Mfd by: M/s. Biolgics Inc., Suketi Road, Kala- Amb, Distt. Sirmour, Himachal Pradesh - 173030 | Dissolution of Telmisartan | Drug Control Department Ladakh | RDTL Chandigarh |
69. | Hydroquinone, Tretinoin and Mometasone Furoate Cream (Melamet Cream) | B. No.: A191070 Mfg dt: 12/2020 Exp dt: 01/2023 Mfd by: M/s. Universal Twin Labs, Village Gullarwala, Near Sai Road, Baddi, Dist.- Solan, Himachal Pradesh. | pH, Identification and Assay of Hydroquinone, Tretinoin and Mometasone Furoate | Drug Control Department Delhi | RDTL Chandigarh |
70. | Steptococcus Faecalis, Clostridium Butyricum, Bacillus mesentericus and Lactic Acid Bacillus Capsules | B. No.: CHC-1054 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s. Cotec Healthcare Pvt. Ltd., NH. No.74, Roorkee- Dehradun Highway, Kishanpur, Roorkee- 247667 Haridwar (Uttrakhand). | Identification and Assay of Streptococcus faecalis | CDSCO North Zone | RDTL Chandigarh |
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