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Date: 2021-08-13 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of July 2021

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • This gazette notification lists drugs, medical devices, and cosmetics that were declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for the month of July 2021.
  • A total of 1028 samples were tested, with 983 samples meeting the standard quality.

Key Changes

  • 44 samples were declared as Not of Standard Quality.
  • 0 samples were declared as Spurious.
  • 1 sample was declared as Misbranded.
  • The notification provides a detailed list of the 45 items, including their name, batch number, manufacturing and expiry dates, manufacturer, reason for failure, and the source from which the sample was drawn.
  • Reasons for failure include issues with Assay, Dissolution, Disintegration, Uniformity of Dispersion, Water Content, Related Substances, Description, Identification, pH, Water, Particulate Matter, Clarity of Solution, Assay of Ethanol, Sodium Potassium Total Chlorides and Citrate.

Impact Analysis

Manufacturers

  • Action Item: Review manufacturing processes and quality control procedures to identify and address any deficiencies. Engage with regulatory authorities to address findings and implement corrective actions.

Distributors and Retailers

  • Action Item: Immediately cease distribution and sale of the listed products. Coordinate with manufacturers for product recalls and communicate with customers regarding the issue.

Consumers

  • Action Item: Raise awareness among consumers about the listed products and their potential risks. Advise consumers to discontinue use of the products and seek medical advice if they experience any adverse effects.

Regulatory Authorities

  • Action Item: Strengthen surveillance and enforcement activities to ensure compliance with quality standards. Review and update regulations to address emerging challenges in the pharmaceutical and cosmetic industries.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratory CDL: Central Drugs Laboratory IP: Indian Pharmacopoeia
Official Source Record View Original Source →
See Full Document Text
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded, for the Month of July – 2021 Total number of samples tested 1028 Total number of samples declared as of Standard Quality 983 Total number of samples declared as Not of Standard Quality 44 Total number of samples declared as Spurious 0 Total number of samples declared as Misbranded 01 S.No. Name of Batch No./Date of Reason for Drawn By From Drugs/medical Manufacture/Date of failure device/cosmetic Expiry/Manufactured By s 1. Calcium B. No.: MT191327 Assay of CDSCO RDTL, Carbonate, Mfg dt: 08/2019 Vitamin D3 Sub-Zone, Guwahati Guwahati Magnesium Exp dt: 07/2021 Oxide, Mfd by: M/s. Mascot Manganese Health Series Pvt. Ltd. Plot No. 79, 80, Sector - Sulphate, Zinc & Vitamin D3 6A, IIE, Sidcul, Haridwar- Uttarakhand -249403. Tablets 2. Supradyn B. No.: MH3388 Disintegration Drug Control RDTL, (Multivitamin Mfg dt: 10/2019 Department Guwahati Exp dt: 09/2021 Mizoram Tablets with Mfd by: M/s. Piramal Minerals and Enterprises Ltd., K-1, Trace Elements) Addl., MIDC area, Mahad Maharashtra, 402302. 3. Ramipril Tablets B. No.: KM19001 Assay Drug Control RDTL, IP Mfg dt: 11/2019 Department N.F. Guwahati Exp dt: 10/2021 Railway (ORMIPRO-2.5) Mfd by: M/s. Ortin Lumding Laboratories Ltd. 275 & 278 (part) I.D.A. Pashamailaram Medak Distt. Telangana -502307. 4. Albendazole B. No.: JDT0047 Dissolution Drug Control RDTL, tablets IP 400 mg Mfg dt: 08/2018 Department Guwahati (ZEEBEE - Exp dt: 07/2021 Tezpur, Tablet) Mfd by: M/s. Syncom Sonitpur Healthcare Ltd., Dehradun, Uttarakhand-248197. 5. DRMET FORTE B. No.: TN-2830 Assay & Drug Control RDTL, G1 (Glimepiride & Mfg dt: 01/2020 Dissolution of Department Guwahati Exp dt: 12/2021 Mizoram Metformin Glimepiride Mfd by: M/s. Neptune Life Hydrochloride SR Science Pvt. Ltd., 100-B, Tablets) EPIP, Phase-II, Thana, Baddi-173205, Himachal Pradesh. 6. Domperidone B. No.: L6002 Assay Drug Control RDTL, Suspension I.P. Mfg dt: 12/2019 Department Guwahati Exp dt: 11/2021 Nagaland Mfd by: M/s. Quest Laboratories Pvt. Ltd., Plot No. 45, Sector –III, Pithampur, Dist. - Dhar, 454775, Madhya Pradesh. 7. Calcium & B. No.: LTA-6957 Assay of Drug Control RDTL, Vitamin D3 Mfg dt: 03/2020 Vitamin D3 Department Guwahati Exp dt: 08/2021 Assam Tablets I.P. Mfd by: M/s. Lifevision (CALGIO-D3) Healthcare, Plot No. 140- 141, E.P.I.P., Phase-1, Jharmajri, Baddi, Dist.- Solan, Himachal Pradesh - 174103. 8. Brutab-400 B. No.: BRU18007 Dissolution Drug Control RDTL, (Ibuprofen Mfg dt: 03/2019 Department Guwahati Exp dt: 02/2022 Nagaland Tablets IP 400 Mfd by: M/s. Neutec mg) Healthcare Pvt. Ltd., E-698, DSIIDC Industrial Area, Narela, Delhi- 110040. 9. (Levoziv -500) B. No.: 420-1087 Dissolution Drug Control RDTL, Levofloxacin Mfg dt: 07/2020 Department Guwahati Tablets I.P. Exp dt: 06/2023 Nagaland 500 mg Mfd by: M/s. Zee Laboratories Ltd. Behind 47, Industrial Area, Paonta Sahib, Himachal Pradesh - 173025. 10. Paracetamol B. No.: BCN2002 Dissolution Drug Control RDTL, Tablets I.P. Mfg dt: 01/2020 Department Guwahati Exp dt: 12/2021 Nagaland 500 mg (Biocin) Mfd by: M/s. DanishHealthcare (P) Ltd. 76/27-28, Industrial Estate, Maxi Road, Ujjain, Madhya Pradesh – 456010. 11. Amlodipine B. No.: GLL19018 Assay Drug Control RDTL, Besilate Tablets Mfg dt: 03/2019 Department Guwahati Exp dt: 02/2022 Nagaland IP 5 mg Mfd by: M/s. IBN Herbals, (AMLORACE-5) Khasra No 63, Vill- Juddi Kalan, Baddi-173205, Dist- Solan, Himachal Pradesh. 12. Methylergometrin B. No.: 1166-01 Assay CDSCO RDTL, e Tablets IP Mfg dt: 05/2020 Sub-Zone Guwahati Exp dt: 04/2022 0.125 mg Guwahati Mfd by: M/s. Hab Pharmaceuticals & Research Limited, 10, Pharmacity, SIDCUL, Selaqui, Dehradun- 248011, Uttarakhand. 13. Cefixime B. No.: 20D-BT016 Uniformity Of CDSCO RDTL, Dispersible Mfg dt: 07/2020 Dispersion Sub-Zone Guwahati Tablets IP Exp dt: 06/2022 Guwahati (Cefimax-100 DT) Mfd by: M/s. Orison Pharma International, Khari, Mauza-Ogli, Kala Amb, Himachal Pradesh - 173030. 14. Linezolid Tablets B. No.: GT200808 Dissolution CDSCO RDTL, IP Mfg dt: 06/2020 Sub-Zone Guwahati Exp dt: 05/2022 Guwahati Mfd by: M/s. Theon Pharmaceuticals Ltd. Vill. Saini Majra, Teh. Nalagarh, Dist. Solan, Himachal Pradesh - 174101. 15. Cosmic-AZ B. No.: MT-1911208 Disintegration Drug Control RDTL, Tablets Mfg dt: 11/2019 Department Guwahati Exp dt: 10/2021 Jharkhand Mfd by: M/s. Medox Lifesciences, Plot No- 222-223, Phase- III, Ind. Area, Sansarpur- Terrace, Distt. Kangra, Himachal Pradesh -176501. 16. Norfloxacin B. No.: NT-802 Dissolution CDSCO RDTL, Tablets IP 400 Mfg dt: 10/2020 Sub-Zone Guwahati mg Exp dt: 09/2022 Guwahati Mfd by: M/s. Unicure India Ltd. C-21, 22 & 23, Sector- 3, Noida, Uttar Pradesh - 201301. 17. Quinine Sulphate B. No.: T8296 Dissolution Drug Control Tablets I.P. 300 Mfg dt: 10/2018 Department RDTL, Exp dt: 09/2021 mg Assam Guwahati Mfd by: M/s. Bharat Parenterals Ltd. Vill Haripura, Ta. Savil, Dist.- Vadodara - 391520, Gujarat. 18. Natural Sunshine B. No.: 007 Assay of Drug Control RDTL, Hand Mfg dt: 03/2020 Ethanol Department Guwahati Exp dt: Best before 24 Sanitizer (100ml) (Misbranded) Jharkhand months Chlorhexidine ‘Mfg. Lic No.’’ is Mfd by: M/s. SHREE Gluconate not mentioned ENTERPRISES Plot No 1, Solution IP 2.5% on the Label. Near Star Talkies, Ethnol IP70% Burmamines, Jamshedpur, Hence, Jharkhand -831007. Misbranded. 19. Amoxycillin B. No.: YAT91042 Assay Drug Control RDTL, Capsule IP 500 Mfg dt: 10/2019 Department Guwahati Exp dt: 09/2021 mg Assam Mfd by: M/s. Yoluri Formulation Pvt. Ltd. Sy No.: 296/7/6, I.D.A., Bollaram, Sangareddy Dist: 502325, Telengana. 20. Norfloxacin B. No.: RID-1925 Dissolution Drug Control RDTL, Tablets IP 400 Mfg dt: 02/2020 Department Guwahati mg Exp dt: 01/2023 Assam (Ridnor-400) Mfd by: M/s. RIDLEY LIFE SCIENCE PVT. LTD. D- 1651, DSIDC, Indl. Complex, Narela, Delhi- 110040. 21. TEMPNIL-500 B. No.: 20NT0404 Dissolution Drug Control RDTL, (Paracetamol Mfg dt: 04/2020 Department Guwahati Tablets IP 500 Exp dt: 03/2022 Assam Mfd by: M/s. Nuclotecmg) Remedies Pvt. Ltd. 14, Milestone, Rudrapur- Kashipur Road, Gadarpur, Distt.-U.S. Nagar, Uttarakhand – 263152.. 22. Rabeprazole B. No.: LTA-7123 Dissolution Drug Control RDTL, Sodium Gastro Mfg dt: 04/2020 Department Guwahati Resistant Tablets Exp dt: 03/2022 Assam IP Mfd by: M/s. Lifevision (RABGIO-20) Healthcare (a WHO-GMP Certified Company) Plot no.140-141, E.P.I.P. Phase-1, Jharmajri, Baddi, dist. Solan, Himachal Pradesh -174103. 23. Glimepiride B. No.: T20053 Dissolution Drug Control RDTL, Tablets Mfg dt: 05/2020 Department Guwahati IP 1 mg Exp dt: 04/2022 Assam Mfd by: M/s. Trugen Pharmaceuticals Pvt. Ltd. Vill-Tejjupur, Near Chodiala Rly Station, Roorkee, Distt. Haridwar, Uttarakhand -247661. 24. Cefixime B. No.: BIG -137 Uniformity of CDSCO RDTL, Dispersible Mfg dt: 03/2019 dispersion and Sub-Zone Guwahati Tablets I.P. Exp dt: 02/2022 Water content Guwahati (Cefexi-100) Mfd by: M/s. Indo-Gulf Pharmaceuticals (unit of I.G. Pharma Ltd.), 12.4 km, Meerut Road, Roorkee, Distt- Haridwar, Uttarakhand. 25. STATIX -20 B. No.: BPSB20093 Related CDSCO CDL (Atorvastatin Mfg dt: 08/2020 Substances Sea Port Office Kolkata Exp dt: 07/2022 Tablets IP 20 mg) Visakhapatnam Mfd by: M/s. Swiss Garnier Andhra Pradesh Biotech Pvt. Ltd., 21, Industrial Area, Mehatpur, Dist. Una, Himachal Pradesh – 174315. 26. Calastravit -500 B. No.: MT20013 Dissolution CDSCO CDL (Calcium with Mfg dt: 10/2020 Sea Port Office Kolkata Exp dt: 09/2022 Vitamin D3 Visakhapatnam Mfd by: M/s. Maa Pharma Tablets IP) Andhra Pradesh Tech, Survey No. 915/2,Block Part B, Jetalpur Pirana Road, At & Post. Girmatha Village, Tal- Daskroi, Dist. Ahmedabad – 382 425, Gujarat. 27. Cefoperazone for B. No.: CS-0016 Description, CDSCO CDL Injection I.P. Mfg dt: 04/2021 Identification, Sub - Zone Kolkata Exp dt: 03/2023 1000 mg pH, Water, Baddi Mfd by: M/s. Sunvet Particulate Pharma Private Limited, Matter, Clarity of Village: Upper Moginand, Solution, Assay Nahan Road, Kala Amb, Distt. Sirmour 173030, Himachal Pradesh. 28. Doxycycline B. No.: 3157 Assay CDSCO CDL Hydrochloride Mfg dt: 03/2020 South Zone Kolkata Exp dt: 02/2022 Capsules I.P. Chennai Mfd by: M/s. Super 100 mg Formulations Pvt. Ltd., 16 B & 15 F, Industrial Area, Maxi Road, Ujjain, Madhya Pradesh - 456 010. 29. Folic Acid Tablets B. No.: T20072 Description & CDSCO CDL IP 5 mg Mfg dt: 07/2020 Hydrolysis South Zone Kolkata Exp dt: 06/2022 Products Chennai Mfd by: M/s. Trugen Pharmaceuticals Pvt. Ltd., Vill. Tejjupur, Near Chodiala Rly Station, Roorkee, Distt. Haridwar, Uttarakhand – 247 661. 30. Sodium Valproate B. No.: SVT871 Related CDSCO CDL Gastro Resistant Mfg dt: 12/2020 Substances South Zone Kolkata Exp dt: 05/2022 Tablets IP 200 Chennai Mfd by: M/s. Unicure India mg Ltd., Noida – 201301, Uttar Pradesh. 31. K-Life B. No.: KL2001 Sodium CDSCO CDL (Oral Rehydration Mfg dt: 01/2020 Potassium Total South Zone Kolkata Exp dt: 12/2021 Salts I.P.) Chlorides and Chennai Mfd by: M/s. Danish Citrate Healthcare (P) Ltd., 76/27- 28 Industrial Estate, Maxi Road, Ujjain – 456 010, Madhya Pradesh.32. Telmicept 40 B. No.: C21T479003 Dissolution CDSCO CDL (Telmisartan Mfg dt: 09/2019 East Zone Kolkata Exp dt: 08/2022 Tablets I.P. 40 Kolkata Mfd by: M/s. Concept mg) Pharmaceuticals Ltd., A - 28/3, MIDC, Chikalthana, Aurangabad – 431 006, Maharashtra. 33. OZOPINE – 10 B. No.: DGTA12266 Dissolution CDSCO CDL (Olanzapine Mfg dt: 12/2020 East Zone Kolkata Exp dt: 11/2022 Tablets IP 10 mg) Kolkata Mfd by: M/s. Digital Vision, 176, Mauza Ogli, Nahan Road, Kala-Amb, Distt. Sirmour, Himachal Pradesh- 173 030. 34. RINGOLATE B. No.: 2001017019 Potassium CDSCO CDL 500 ml Mfg dt: 01/2020 East Zone Kolkata Exp dt: 12/2022 (Compound Kolkata Mfd by: M/s. Denis Chem Sodium Lactate Lab Limited, 457, Chhatral, Inj. I.P. 500 ml Ta. Kalol, Dist. (Ringer Lactate Gandhinagar, Gujarat – Solution for 382 729. Injection I.P) 35. Fexofenadine B. No.: CT-8321220 Dissolution CDSCO CDL Tablets I.P. Mfg dt: 12/2020 East Zone Kolkata Exp dt: 11/2022 120 mg Kolkata Mfd by: M/s. Clevus Lifesciences, Near Apple Terminal Market, Sector - 6, Parwanoo, Himachal Pradesh – 173 220. 36. Absorbent Gauze B. No.: 09 Weight in gm / CDSCO CDL Mfg dt: 01/2021 m2, Length, Sub - Zone Kolkata Exp dt: 3 Yrs from Mfg. Width, Foreign Bangalore Date Matter and Mfd by: M/s. Sri Sanjeevi Flourescence Natchiyar Surgicals, 2/181- D, Vayakattu Street, Samusigapuram – 626 102 (via), Rajapalyam, Tamilnadu.37. FloxidinTM VET – B. No.: FN2220046 pH Drug Control CDL 100 ml Mfg dt: 11/2020 Department Kolkata Exp dt: 10/2022 (Enrofloxacin Bangalore Mfd by: M/s. Samrudh Injection I.P. 10% Pharmaceuticals Pvt. Ltd., VET) Plot No. J-174, J-168 & J- 168/1 MIDC, Tarapur, Thane – 401 506, Maharashtra. 38. Remdesivir for B. No.: BREMD210001 Water and CDSCO CDTL Injection Mfg dt: 04/2021 Residue on Hyderabad Mumbai Exp dt: 03/2024 ignition Mfd by: M/s. Teena Labs Ltd. Plot No. 41,S.V. Co- Operative Industrial Estate, Bachupally (V & M), Medchal-Malkajgiri, District Telangana State-500090. 39. Ampicillin 500 mg B. No.: 475 Assay CDSCO CDTL (Ampicillin Mfg dt: 02/2020 West Zone Mumbai Exp dt: 01/2022 Capsules I.P.) Mumbai Mfd by: M/s. Super Pharma Products., 13 A & C, Industrial Area, Maksi Road, Ujjain, Madhya Pradesh. 40. Orvastin-40 B. No.: P-0C0154 Dissolution CDSCO CDTL (Atorvastatin Mfg dt: 03/2020 West Zone Mumbai Exp dt: 08/2022 Tablets I.P. 40 Mumbai Mfd by: M/s. Morepen mg) Laboratories Ltd., Plot No. 12B, Sector-2, Parwanoo, Dist. Solan, Himachal Pradesh – 173220. 41. Closantel 15% B. No.: CLP-443 Identification Drug Control RDTL Oral Solution Mfg dt: 03/2020 (Negative for Department Chandigarh Exp dt: 02/2022 (WORM- GO Closantel Srinagar Mfd by: M/s. Saibliss ORAL Sodium Drugs & Pharmaceuticals SOLUTION) Dihydrate) 66-67, Ind.Area, Ponta Sahib, Distt. Sirmour, Himachal Pradesh.42. Liposomal B. No.: A18021003 Identification Drug Control RDTL Amphotericin Mfg dt: 02/2021 (Negative for Department Chandigarh Exp dt: 01/2024 B Injection 50 mg Amphotericin B) Delhi Mfd by: M/s. Bharat (ABHOPE INJ.) Serums and Vaccines Ltd. Plot No. K-27, Anand Nagar, Add.MIDC, (E) Ambernath-421501, Taluka: Ambernath City, District: Thane-Zone 6, Maharashtra. 43. Remdesivir for B. No.: R310019 Identification Drug Control RDTL Injection 100 Mfg dt: 03/2021 (Negative for Department Chandigarh Exp dt: 11/2021 mg/vial Remdesivir) Delhi Mfd by: M/s. CIPLA LTD. (CIPREMI) Plot No. G-84/1, Tarapur, M.I.D.C., Boisar, Dist, Palghar, Maharashtra- 401506. 44. Amphotericin B. No.: R310019 Identification Drug Control RDTL B Lipid Complex Mfg dt: 03/2021 (Negative for Department Chandigarh Exp dt: 10/2022 Injection I.V. Amphotericin B) Delhi Mfd by: M/s. BHARAT (AMPHOLIP 50 SERUMS AND VACCINS MG/10 ML) LIMITED Plot No. K-27, Additional M.I.D.C., Ambernath (E) 421501, Maharashtra. 45. Enalapril Maleate B. No.: CT-201041 Assay Drug Control RDTL Tablets IP Mfg dt: 12/2020 Department Chandigarh Exp dt: 11/2022 (GNAP-2.5 Himachal Mfd by: M/s. CMG TABLETS) Pradesh BIOTECH PVT. LTD 58, Industrial Area, Phase III, Sansarpur Terrace, Himachal Pradesh - 176501.

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