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Date: 2022-09-12 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of August 2022

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

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Executive Summary & Key Takeaways

Gazette Overview

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for August 2022.
  • Out of 1330 samples tested, 1285 were declared as of Standard Quality, and 45 were declared as Not of Standard Quality.
  • There were no samples declared as Spurious or Misbranded.

Key Changes

  • 45 samples failed quality tests and were declared Not of Standard Quality.
  • The failures were attributed to various reasons, including issues with assay, dissolution, sterility, uniformity of dispersion, particulate matter, bacterial endotoxins, and identification.
  • The listed products include various drugs like Methylcobalamin capsules, Primaquine Phosphate tablets, Paracetamol tablets, Ciprofloxacin & Tinidazole tablets, Levocetirizine Dihydrochloride and Montelukast Sodium tablets, Pantoprazole Sodium tablets, Ivermectin tablets, Amoxycillin & Potassium Clavulanate tablets, Vitamin D3 Chewable Tablets, Norfloxacin Tablets, CEFADROXIL TABLETS, Domperidone Tablets, Iron Sucrose Injection, Sertraline Tablets, Itraconazole Capsules, Sodium Bicarbonate Tablets, Ursodeoxycholic Acid Tablets, Rabeprazole Sodium and Domperidone Sodium Tablets, Teneligliptin Tablets, Ciprofloxacin Tablets, Aluminium Hydroxide, Magnesium Trisilicate and Activated Polydimethylsiloxane Suspension, as well as medical devices like Sterile Single Use Hypodermic Needles and Cotton Gauze Absorbent.
  • The manufacturers of the listed products are located across India, including Himachal Pradesh, Gujarat, Haryana, Bihar, Rajasthan, Uttarakhand, Delhi, West Bengal, Karnataka, Maharashtra, Madhya Pradesh, Assam, Meghalaya, Odisha, Uttar Pradesh, Tamil Nadu, Sikkim and Chandigarh.
  • The testing was conducted by various CDSCO (Central Drugs Standard Control Organization) sub-zones and RDTLs (Regional Drugs Testing Laboratories) across India.

Impact Analysis

Impact on Manufacturers

  • Suggested Action: Conduct a thorough internal investigation to identify the causes of the quality failures. Implement CAPA measures and enhance quality control processes.

Impact on Consumers

  • Suggested Action: Healthcare providers should be informed about the affected products to ensure patient safety. A system should be in place to address consumer complaints and provide necessary support.

Impact on Regulatory Agencies

  • Suggested Action: Enhance collaboration between central and state drug control authorities. Increase the frequency of inspections and sample testing. Implement stricter penalties for manufacturers of substandard products.

Impact on Supply Chain

  • Suggested Action: Implement a robust system for tracking and tracing pharmaceutical products. Ensure that all products are sourced from licensed and reputable manufacturers.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratory, a network of laboratories responsible for testing and analyzing drug samples. Drugs and Cosmetics Act, 1940: The primary legislation governing the quality, safety, and efficacy of drugs and cosmetics in India (Implied). Drugs and Cosmetics Rules, 1945: The rules framed under the Drugs and Cosmetics Act, 1940, which provide detailed guidelines for the manufacture, sale, and distribution of drugs and cosmetics in India (Implied).
Official Source Record View Original Source →
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of August – 2022. Total number of samples tested 1330 Total number of samples declared as of Standard Quality 1285 Total number of samples declared as Not of Standard Quality 45 Total number of samples declared as Spurious - Total number of samples declared as Misbranded - S.No. Name of Batch No./Date of Reason for Drawn By From Drugs/medical Manufacture/Date of failure device/cosmetics Expiry/Manufactured By 1. Methylcobalamin B. No.: 28021831 Description and CDSCO RDTL and Alpha Lipoic Mfg dt: 04/2021 Assay of Alpha Sub Zone Guwahati Acid Capsules Exp dt: 02/2023 Lipoic Acid Guwahati Mfd by: M/s. USV Private Limited Plot No. 6 & 7E, HPSIDC Indl. Area, Baddi, Dist.: Solan, Himachal Pradesh- 173205. 2. Primaquine B. No.: TP-980001 Assay CDSCO RDTL Phosphate Tablets Mfg dt: 12/2020 Sub Zone Guwahati I.P. 2.5 mg. Exp dt: 11/2022 Guwahati Mfd by: M/s. Centurion Remedies Pvt. Ltd., G- 5 & G-6, Industrial Estate, Gorwa, Vadodara- 390016, Gujarat. 3. Paracetamol B. No.: TGT05212515 Dissolution Drug Control RDTL Tablets I.P. 500 mg. Mfg dt: 05/2021 Department Guwahati Exp dt: 04/2023 Assam Mfd by: M/s. T & G Medicare, Village Kunjahal PO-Baddi Dist. Solan, Himachal Pradesh. 4. Paracetamol B. No.: PRT - 938 Dissolution Drug Control RDTL Tablets IP 650 mg. Mfg dt: 05/2021 Department Guwahati (DOL-P*650) Exp dt: 04/2023 Assam Mfd by: M/s. ALCO FORMULATION Page 1 of 10(INDIA), 14/5, Mathura Road, Faridabad- 121003, Haryana. 5. Ciprofloxacin & B. No.: RT-007 Assay Drug Control RDTL Tinidazole Tablets Mfg dt: 09/2020 Department Guwahati Cipkon-TZ Exp dt: 08/2022 Bihar Mfd by: M/s. RIKON PHARMACEUTICALS PVT. LTD. Unit at: D-6, Phase-III, Indl. Area, Fatuha. (India), Bihar. 6. (PRICON) Sterile B. No.: 38GB0621070 Sterility Drug Control RDTL Single Use Mfg dt: 06/2021 Department Guwahati Hypodermic Needle Exp dt: 05/2024 Rajasthan Mfd by: M/s. ISCON SURGICALS LTD., B- 70, M.I.A., Phase II, Basni, Jodhpur 342 005 (INDIA), Rajasthan. 7. Primaquine Tablets B. No.: 191134 Assay CDSCO RDTL I.P. 7.5 mg. Mfg dt: 11/2019 Sub Zone Guwahati Exp dt: 10/2022 Guwahati Mfd by: M/s. Modi Antibiotics, Plot No. 28, G.I.D.C. Estate, Odhav, Ahmedabad – 382 415 GUJARAT. 8. Levocetirizine B. No.: 21112704 Dissolution of CDSCO RDTL Dihydrochloride and Mfg dt: 05/2021 Montelukast Sub Zone Guwahati Montelukast Sodium Exp dt: 04/2023 Guwahati Tablets IP Mfd by: M/s. MERCURY LABORATORIES LTD. Unit No. 2, Halol- Baroda Road, Village: Jarod, Tal: Waghodia, Dist: Vadodara- 391510, Gujarat. 9. Pantoprazole B. No.: POF-01 Assay Drug Control RDTL Sodium Tablets IP Mfg dt: 10/2021 Department Guwahati 40mg. Exp dt: 09/2023 Assam Mfd by: M/s. Applied Communication & Page 2 of 10Controls, Khasra No. 122, Selaqui Industrial Area, Dehradun, Uttarakhand – 248 011. 10. Chlordiazepoxide 5 B. No.: D2050026 Assay of Drug Control RDTL mg & Amitriptyline Mfg dt: 12/2020 Chlordiazepoxide Department Guwahati Hydrocholoride Exp dt: 11/2023 Bihar 12.5mg Tablets Mfd by: M/s. USP Libotryp WOCKHARDT LIMITED Plot No. 57, Village Kunjhal P.O. Barotiwala Teh, Nalagarh, Distt. Solan, Himachal Pradesh - 174103. 11. Ivermectin Tablets B. No.: PT0031 Dissolution Drug Control RDTL USP Mfg dt: 05/2021 Department Guwahati Exp dt: 04/2023 Arunachal Mfd by: M/s. OMEGA Pradesh PHARMA, Khasra No. 482, Village- Saliyar, Roorkee- 247667, Distt. Haridwar, Uttarakhand. 12. Amoxycillin & B. No.: MBT22020 Dissolution of CDSCO RDTL Potassium Mfg dt: 03/2022 Potassium Sub Zone Guwahati Clavulanate Tablets Exp dt: 08/2023 Clavulanate Guwahati IP (DEMOXYCLAV) Mfd by: M/s. Mediwell Biotech, Plot No. 21- 22, Phase-IV, Himuda Industrial Township, Bhatolikalan, Baddi, Dist. Solan, Himachal Pradesh – 173205. 13. Vitamin D3 B. No.: MUTBC2101 Description Drug Control RDTL Chewable Tablets Mfg dt: 07/2021 Department Guwahati 60,000 IU Exp dt: 06/2023 Meghalaya Mfd by: M/s. MAXTAR BIO-GENICS, Khasra No. 705, Vill. Malku Majra, Nalagarh Road, Baddi, Distt. Solan- 173205, Himachal Page 3 of 10Pradesh – India. 14. Norfloxacin Tablets B. No.: NOR-2001 Dissolution Drug Control RDTL IP Mfg dt: 01/2021 Department Guwahati Exp dt: 12/2022 Meghalaya Mfd by: M/s. RIDLEY LIFE SCIENCE PVT. LTD. D-1651, DSIDC, Indl Complex, Narela, Delhi-110040. 15. CEFADROXIL B. No.: T2072 Dissolution Drug Control RDTL TABLETS I.P. 500 Mfg dt: 03/2022 Department Guwahati mg Exp dt: 02/2024 Assam Mfd by: M/s. ZEST PHARMA Plot No. 275, Sector ‘F’ Sanwer Road, Indore - 452 015, Madhya Pradesh. 16. Norfloxacin Tablets B. No.: RID-1925 Dissolution Drug Control RDTL IP Ridnor-400 Mfg dt: 02/2020 Department Guwahati Exp dt: 01/2023 Assam Mfd by: M/s. RIDLEY LIFE SCIENCE PVT. LTD. D-1651, DSIDC Indl. Complex, Narela, Delhi- 110040. 17. Dispersible B. No.: AXT 11072 Uniformity of CDSCO CDL Amoxycillin Tablets Mfg dt: 12/2021 Dispersion East Zone Kolkata I.P. 125 mg Exp dt: 11/2023 Kolkata Mfd by: M/s. Caplet India Pvt. Ltd., Works: Rekjuani, Rajarhat , Kolkata - 700 135. 18. Oflopac-OZ Tablet B. No.: APNT/206 Identification CDSCO CDL (Ofloxacin & Mfg dt: 04/2022 & East Zone Kolkata Ornidazole Tablet Exp dt: 03/2024 Assay Kolkata I.P.) Mfd by: M/s. Amkon Pharmaceuticals Pvt. Ltd., Plot No. 253, Phase-IX, Industrial Area, S.A.S. Nagar, Mohali-160062 Punjab. 19. CANZON B. No.: 21006 Dissolution CDSCO CDL (Ciprofloxacin Mfg dt: 03/2021 East Zone Kolkata Page 4 of 10Tablets I.P. 500 mg) Exp dt: 02/2024 Kolkata Mfd by: M/s. Diamond Drugs Pvt. Ltd., A.T. Ghosh Road, Jagacha, Howrah -711112, Kolkata. 20. Domperidone B. No.: 3100221 Related CDSCO CDL Tablets I.P. 10 mg Mfg dt: 05/2021 Substances East Zone Kolkata Exp dt: 04/2024 Kolkata Mfd by: M/s. Karnataka Antibiotics & Phamacetucials Limited, Plot No. 14, II Phase, Peenya, Bengaluru - 560 058, Karnataka. 21. Iverzest 12 B. No.: PNT3940D Uniformity of CDSCO CDL (Ivermectin Mfg dt: 05/2021 Dispersion East Zone Kolkata Dispersible Tablets Exp dt: 04/2023 Kolkata 12 mg) Mfd by: M/s. Plena Remedies, Plot No. 17, Industrial Area (Himuda), Bhatoli Kalan, Baddi, Distt. Solan, Himachal Pradesh- 173205. 22. Iron Sucrose B. No.: ISI21019 Particulate Matter CDSCO CDL Injection U.S.P. 5 ml Mfg dt: 05/2021 East Zone Kolkata Exp dt: 04/2023 Kolkata Mfd by: M/s. Vivek Pharmachem (India) Ltd., NH-8, Chimanpura, Amer, Jaipur-303102, Rajasthan. 23. Paracetamol B. No.: BTPM110 Dissolution CDSCO CDL Tablets I.P. 650 mg Mfg dt: 09/2021 East Zone Kolkata Exp dt: 08/2023 Kolkata Mfd by: M/s. ANG Lifesciences India Ltd., Vill. Malkumajra, Nalagarh Road, Baddi, Distt. Solan 173 205, Himachal Pradesh. Page 5 of 1024. Domperidone B. No.: 2110138 Related CDSCO CDL Tablets I.P. 10 mg Mfg dt: 10/2021 Substances South Zone Kolkata Exp dt: 09/2023 Mfd by: M/s. Adroit Pharmaceuticals Pvt. Ltd., 46, Garoba Maidan, Nagpur – 440 008, Maharashtra. 25. Mymi D (Alpha B. No.: TT22002 Assay of Alpha CDSCO CDL Lipoic Acid, Mfg dt: 03/2022 Lipoic Acid, South Zone Kolkata Pyridoxine Exp dt: 02/2024 Methylcobalamin Hydrochloride Mfd by: M/s. Kausikh and Vitamin D 3 Methylcobalamin Therapeutics (P) Ltd., Folic Acid & Vitamin Unit II, Plot No. 54 D3 Tablets) SIDCO Industrial Estate, Thirumudivakkam, Chennai 600 044, Tamil Nadu. 26. Metsodoz – 4 B. No.: GFM02 2102 Assay CDSCO CDL Tablets Mfg dt: 08/2021 South Zone Kolkata (Methylprednisolone Exp dt: 07/2023 Tablets IP 4 mg) Mfd by: M/s. Progressive Lifesciences Pvt. Ltd., Latherdevahoon, P.O. Jhabrera, Roorkee, Distt. Haridwar – 247 665, Uttarakhand. 27. Mymifer (Ferrous B. No.: LT21008 Assay of CDSCO CDL Ascorbate and Folic Mfg dt: 10/2021 Folic Acid South Zone Kolkata Acid Suspension) Exp dt: 03/2023 Mfd by: M/s. Kausikh Therapeutics (P) Ltd., Unit II, Plot No. 54, SIDCO Industrial Estate, Thirumudivakkam, Chennai - 600044. 28. RL – 500 ml, B. No.: 112036 Sterility Drug Control CDL Compound Sodium Mfg dt: 12/2021 Department Kolkata Lactate Injection IP Odisha Exp dt: 11/2023 (Ringer Lactate Mfd by: M/s. Ives Solution for Drugs (India) Pvt. Ltd., Injection) Page 6 of 10Works: Ghatabillod, Dist. Dhar, H.O.: 504, Chetak Center, R.N.T. Marg, Indore -1, India. 29. RL – 500 ml, B. No.: S2FBV33 Bacterial Drug Control Compound Sodium Mfg dt: 02/2022 endotoxins Department CDL Lactate Injection IP Odisha Exp dt: 01/2024 Kolkata (Ringer Lactate Mfd by: M/s. Swaroop Solution for Pharmaceuticals Pvt. Injection) Ltd., A-10, Tala Nagari Industrial Area, Aligarh - 202 001, Uttar Pardesh. 30. RL – 500 ml, B. No.: S2FBV24 Bacterial Drug Control CDL Compound Sodium Mfg dt: 02/2022 endotoxins Department Kolkata Lactate Injection IP & Odisha Exp dt: 01/2024 (Ringer Lactate Sterility Mfd by: M/s. Swaroop Solution for Pharmaceuticals Pvt. Injection) Ltd., A-10, Tala Nagari Industrial Area, Aligarh - 202 001, Uttar Pardesh. 31. Iron Sucrose B. No.: IS20043 Particulate Matter CDSCO CDL Injection U.S.P. Mfg dt: 10/2020 and Assay of Iron Ahmedabad Kolkata Exp dt: 09/2022 Mfd by: M/s. Maan Pharmaceuticals Ltd., Plot – 1, G.I.D.C. Phase -II, Modhera Road, Mehsana, Gujarat, India. 32. Sertraline Tablets B. No.: GM20105 Dissolution CDSCO CDL I.P. 50 mg Mfg dt: 11/2020 Ahmedabad Kolkata Exp dt: 10/2022 Mfd by: M/s. Skymap Pharmaceuticals Pvt. Ltd., B-3, Devbhoomi Industrial Estate, Puhana, Iqbalpur Road, Roorkee – 247 667, Uttarakhand. 33. Velgut (Prebiotic B. No.: GVGC22003 Assay CDSCO CDL & M fg dt: 02/2022 Guwahati Kolkata Probiotic Capsules) Exp dt: 07/2023 Page 7 of 10Mfd by: M/s. Eris Lifesciences Limited, Amingaon, North Guwahati, Dist. Kamrup – 781 031, Assam. 34. Cotton Gauze B. No.: G-022 Width CDSCO CDL Absorbent (Non- Mfg dt: 11/2021 Ahmedabad Kolkata Sterilized) Exp dt: 10/2023 Mfd by: M/s. Durga Surgical Corporation, P.O. Delhi Road, Fazilpur, Sonepat – 131 001, India. 35. Gentamicin Injection B. No.: VGTA-108A Description Drug Control CDL I.P. (Vet) – 30 ml Mfg dt: 12/2021 and Department Kolkata Particulate Matter Himachal Exp dt: 11/2023 Pradesh Mfd by: M/s. Pushkar Pharma, Bhandariwala, Kheri, Kala-Amb, 173 030, Himachal Pradesh. 36. Ondero Met B. No.: C99671 Dissolution, CDSCO CDL 2.5mg /500 mg Mfg dt: 03/2021 active ingredient Sub - Zone Kolkata (Fixed Dose degradation and Bangalore Exp dt: 08/2022 Combination of Assay of Mfd by: M/s. Linagliptin and Linagliptin Boehringer Ingelheim Metformin India Private Limited, Hydrochloride Tablets) Building No. D-5, Gala No. 1 to 5, Shree Arihant Compound, Ground Floor, Reti Bunder Road, Kalher, Bhiwandi -15, Thane Z5, Bhiwandi, Maharashtra (India) 421302. 37. Theozole B. No.: GC210453 Dissolution CDSCO CDTL (Itraconazole Mfg dt: 06/2021 Ahmedabad Mumbai Capsules BP 100 Exp dt: 05/2023 mg) Mfd by: M/s. Theon Pharmaceuticals Ltd., Page 8 of 10Vill. Saini Majra, Tehsil Nalagarh, Dist. Solan, Himachal Pradesh – 174101. 38. Sodonate-500 B. No.: PNT5806 Assay CDSCO CDTL (Sodium Mfg dt: 12/2021 and West-Zone Mumbai Bicarbonate Tablets Uniformity of Exp dt: 11/2023 USP 500 mg) dosage units Mfd by: M/s. Plena Remedies. Plot no.-17 Industrial Area (Himuda), Bhatoli Kalan, Baddi, Distt. Solan,Himachal Pradesh -173205. 39. Gentamicin Injection B. No.: V2211749 Bacterial CDSCO RDTL IP (GERAGEN Mfg dt: 05/2022 Endotoxins Sub - Zone Chandigarh INJECTION) and Baddi Exp dt: 04/2024 Sterility Mfd by: M/s. B.M.Pharmaceuticals 47-48, Ind. Area, Phase-II, Chandigarh- 160002. 40. Ursodeoxycholic B. No.: TF2037A Identification A, CDSCO RDTL Acid Tablets IP 300 Mfg dt: 06/2022 Identification B Sub - Zone Chandigarh mg (BAKLIV-300 and Assay Baddi Exp dt: 05/2024 TABLETS) Mfd by: M/s. Navkar Lifesciences WHO- GMP Certified Company Plot No. 76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan, Himachal Pradesh. 41. Mefenamic Acid and B. No.: TD2030B Assay of CDSCO RDTL Paracetamol Mfg dt: 04/2022 Mefenamic Acid Sub - Zone Chandigarh Tablets Baddi Exp dt: 03/2024 (MEFIGESIC Mfd by: M/s. Navkar FORTE TABLETS) Lifesciences WHO- GMP Certified Company Plot No. 76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan, Himachal Pradesh. Page 9 of 1042. Rabeprazole B. No.: MT-211153 Assay of Drug Control RDTL Sodium and Mfg dt: 10/2021 Rabeprazole Department Leh Chandigarh Domperidone Sodium U.T. Ladakh Exp dt: 09/2023 Tablets Mfd by: M/s. Matins (RAYBEPOLL-D Healthcare Plot No- TABLETS) 10, Sector-5, I.I.E. Sidcul, HARIDWAR- 249402, Uttarakhand. 43. TENELIGLIPTIN B. No.: 18211147 Dissolution CDSCO CDTL TABLETS I.P. 20mg Mfg dt: 12/2021 Port office, Hyderabad (ZITEN®) Visakhapatnam Exp dt: 11/2023 Mfd by: M/s. Glenmark Pharmaceuticals Ltd. Samlik Marchak, Industrial Growth Centre East Sikkim, Sikkim- 737135. 44. Ciprofloxacin B. No.: CPT22004 Dissolution CDSCO CDTL Tablets IP 500 mg Mfg dt: 05/2022 South - Zone Chennai Exp dt: 04/2024 Mfd by: M/s. Vivek Pharmachem (India) Ltd.,NH-8, Chimanpura, Amer, Jaipur-303102, Rajasthan. 45. Aluminium B. No.: 010122-BTN13 Assay CDSCO CDTL Hydroxide, Mfg dt: 01/2022 South - Zone Chennai Magnesium Exp dt: 12/2023 Trisilicate and Mfd by: M/s. Activated Biogenetic Drugs Pvt. Polydimethylsiloxan Ltd., Vill - Jharmazri, e Suspension (Liquid Baddi –174103, Dist. Antacid) Solan, Himachal Pradesh. Page 10 of 10

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