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Date: 2018-11-01 Category: Not Applicable State: Union Government Country: India

Drug Alert list for October 2018

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 declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for the month of October 2018.
  • The list includes the name of the product, batch number, manufacturing and expiry dates, manufacturer details, reason for failure, and the zone/location where the sample was drawn and tested.

Key Changes

  • A total of 42 products are listed as Not of Standard Quality/Spurious/Adulterated/Misbranded.
  • Reasons for failure include particulate matter, clarity of solution, assay of active ingredients (Folic Acid, Amlodipine, Cholecalciferol, Magnesium Hydroxide, Chloramphenicol, Cefpodoxime Proxetil, Levocetirizine Dihydrochloride, Montelukast, Amoxycillin Trihydrate), specific optical rotation, melting point, description, pH, light absorption, test for Salmonella sp., related substances and decomposition products, dissolution, microbial limit test, disintegration, uniformity of weight, identification, and misbranding.
  • The products were manufactured by various companies located across India, including Himachal Pradesh, Uttarakhand, Madhya Pradesh, Gujarat, Maharashtra, Tamil Nadu, and others.
  • Testing was conducted by CDSCO (Central Drugs Standard Control Organization) sub-zones and various Regional Drugs Testing Laboratories (RDTL) across India.

Impact Analysis

Impact on Manufacturers

  • Action Item: Conduct thorough investigations to identify the root cause of the quality failures and implement corrective and preventive actions (CAPA) to prevent recurrence.

Impact on Consumers

  • Action Item: Healthcare providers should be informed to monitor patients who may have used the affected products and manage any adverse events.

Impact on Regulatory Authorities

  • Action Item: Expedite the investigation and prosecution of manufacturers found to be producing substandard drugs.

Impact on Supply Chain

  • Action Item: Strengthen supply chain monitoring and traceability to prevent the distribution of substandard products.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organization, the national regulatory authority for pharmaceuticals and medical devices in India. RDTL: Regional Drugs Testing Laboratories, responsible for testing drug samples for quality control purposes. Drugs and Cosmetics Act: The primary legislation governing 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 October, 2018 Sl. Name of Batch No./Date of Reason for failure Drawn By From No Drugs/medical Manufacture/Date of . device/cosmetics Expiry/Manufactured By 1. Ceftriaxone Injection B. No.: 0017Z144, Particulate Matter, CDSCO, CDL, I.P. Mfg dt: 08/2017, Clarity of Solution Sub Zone, Kolkata Exp dt: 07/2019, Baddi Mfd by: M/s. Scott Edil Advance Research Laboratories and Education Ltd, Hill Top Ind. Area, Bhatoli Kalan, Baddi, Solan. 2. CEFIPARK 1g (Ceftriaxone for Injection Particulate Matter, CDSCO, CDL, (Ceftriaxone for I.P.) Clarity of Solution Sub Zone, Kolkata Injection I.P.) B. No.: PPPK-00006, Baddi Mfg dt: 11/2017, Exp dt: 10/2019, Mfd by: M/s. Park Pharmaceuticals, Village Kalujhanda, Near Nanakpur, Tehsil Kasauli, Distt Solan (H.P.). (Sterile Water for Injection Sterile Water for I.P. 10 ml) Injection I.P. 10 ml B. No.: W1b 097, Mfg dt: 02/2017, Exp dt: 01/2020 Mfd by: M/s. Omar Healthcare, Baddi, Solan, H.P. 3. NEUFOL-Z (Iron, B. No.: 517-20, Assay of Folic Acid CDSCO, CDL, Folic acid & Zinc Mfg dt: 08/2017, Sub-Zone Kolkata Capsules) Exp dt: 01/2019, Hyderabad Mfd by: M/s. Zee Laboratories Limited, 47, Industrial Area, Paonta Sahib - 173025. 4. Dehydroepiandroster B. No.: DHEA/171801, Specific Optical CDSCO. CDL, one Mfg dt: 08/2017, Rotation Sub-Zone, Kolkata Exp dt: 07/2020, Indore. Mfd by: M/s. Panchsheel Organics Limited., B-6, B-7, Sector - C, Industrial State, Sanwer Road, Indore, M.P.5. Dehydroepiandroster B. No.: DHEA/171802, Specific Optical CDSCO. CDL, one Mfg dt: 11/2017, Rotation Sub-Zone, Kolkata Exp dt: 10/2020, Indore. Mfd by: M/s. Panchsheel Organics Limited., B-6, B-7, Sector - C, Industrial State, Sanwer Road, Indore, M.P. 6. Dehydroepiandroster B. No.: DHEA/161701, Melting Point, CDSCO. CDL, one Mfg dt: 08/2016, Specific Optical Sub-Zone, Kolkata Exp dt: 07/2019, Rotation, Loss on Indore. Mfd by: M/s. Panchsheel drying and Assay Organics Limited., B-6, B-7, Sector - C, Industrial State, Sanwer Road, Indore, M.P. 7. Dexamethasone B. No.: I-13791, Description, CDSCO, CDL, Sodium Phosphate Mfg dt: 03/2017, Particulate Matter South Zone, Kolkata Injection I.P. 2 ml Exp dt: 02/2019, Chennai Mfd by: M/s. Jackson Laboratories Pvt. Ltd., Bye Pass, Majitha Road, Amritsar-143004 8. Rentin (Ranitidine B. No.: R-07, pH CDSCO, CDL, Hydrochloride Mfg dt: 12/2017, South Zone, Kolkata Injection I.P.) Exp dt: 05/2019, Chennai. Mfd by: M/s. Regain Laboratories, 134/5, HTM Road, Raipur Lane, Hisar - 125001. 9. PARADEN B. No.: 17TN58P001, Description, Light CDSCO, CDL, (Paracetamol Mfg dt: 07/2017 Absorption South Zone, Kolkata (as per FM), Infusion I.P. 100 ml Chennai. 01/2017 1.0% w/v) (as per sample label), Exp dt: 12/2018, Mfd by: M/s. Denis Chem Lab Limited, 457, Chahatral, Ta. Kalol (N.G), Pin 382729. 10. Astaxanthin 10 % B. No.: 20171202, Test for Salmonella CDSCO, CDL, Powder Mfg dt: NA., sp. Sub zone, Kolkata Exp dt: NA., Bangalore Mfd by: M/s. Biogen Extracts Private Limited. 11. Astaxanthin 10 % B. No.: 20171202, Test for Salmonella CDSCO, CDL, Powder Mfg dt: NA., sp. Sub zone, Kolkata Exp dt: NA., Bangalore Mfd by: M/s. Biogen Extracts Private Limited.12. DIACALM-5 B. No.: T-18158, Related Substances CDSCO, CDL, (Diazepam Tablets Mfg dt: 12/2016, and Decomposition East Zone, Kolkata I.P.) Exp dt: 11/2019, Products Kolkata. Mfd by: M/s. East West Pharma Unit-2, Kh. No 196, Raipur Industrial Area, Bhagwanpur, Roorkee, Distt Haridwar, Uttarakhand 247661 13. Diamet SR-500 B. No.: UDSR1803, Dissolution CDSCO, CDL, (Metroformin Mfg dt: 04/2018, East Zone, Kolkata Hydrochloride Exp dt: 09/2020, Kolkata. Prolonged Release Mfd by: M/s. Bal Pharma Tablets I.P.) Limited, Plot No. 1, 2, 3 & 69, Sector-4, IIE SIDCUL, Pantnagar, Rudrapur, Distt. - Udham Singh Nagar, Uttarakhand, India 14. Peptac (Ranitidine B. No.: IRH3737, pH CDSCO, CDL, Hydrochloride Mfg dt: 02/2016 East Zone, Kolkata Injection I.P.) (as per FM) Kolkata. 02/2017 (as per Label), Exp dt: 01/2019, Mfd by: M/s. EG Pharmaceuticals, Vill Mandhala, Teh. Kasauli, Distt. Solan (H.P). 15. Calcium & Vitamin B. No.: V098030 Microbial Limit Test CDSCO, CDTL, D3 Suspension Mfg dt: 03/2018, (Total Aerobic West Zone, Mumbai Exp dt: 02/2020, Bacterial Count) Mumbai Mfd by: M/s. Vivimed Labs Ltd., Plot No.25, Kundeshwari Village, Kashipur-244713, Uttarakhand. 16. Shelcal-M (Calcium B. No.: ABA70029 Disintegration CDSCO, CDTL, with Vitamin D3 & Mfg dt: 12/2017 West Zone, Mumbai Minerals Tablets) Exp dt: 11/2019 Mumbai. Mfd by: M/s. Akums Drugs & Pharmaceuticals Ltd., Plot No. 19, 20, 21, Sector-6A, I.I.E, SIDCUL, Ranipur, Haridwar-249403. 17. Pheniramine Maleate B. No.: 66 Related Substances CDSCO, CDTL, Injection I.P. Mfg dt: 01/2018 South Zone, Mumbai Exp dt: 12/2019 Chennai Mfd by: M/s. HindustanMedicines Pvt. Ltd., Barauni- 851112. 18. Atorvabak B. No.: OBLE01 Dissolution CDSCO, CDTL, (Atorvastatin Tablets Mfg dt: 02/2018 West Zone, Mumbai IP) Exp dt: 01/2020 Mumbai Mfd by: M/s. Akums Drugs & Pharmaceuticals Ltd., Plot No. 19, 20,21, Sector-6A, I.I.E, SIDCUL, Ranipur, Haridwar-249403. 19. Atenolol & B. No.: 705369 Assay of Amlodipine CDSCO, CDTL, Amlodipine Tablets Mfg dt: 08/2017 Sub Zone, Mumbai Exp dt: 07/2019 Indore Mfd by: M/s. Ciron Drugs & Pharmaceuticals Pvt. Ltd., Plot No.35 to 37, 43 to 45, CFC-B, Dewan Udyog Nagar, Aliyali, Palghar, Dist. Thane- 401 404. 20. Diclofenac Sodium B. No.: B71682 Description CDSCO, CDTL, Tablets IP 50 mg Mfg dt: 02/2018 (Cracking) & West Zone, Mumbai Exp dt: 01/2020 Disintegration and Mumbai Mfd by: M/s. Bochem Related Substances Healthcare Pvt. Ltd., 83-84, Industrial Area, Dewas Road, Nagziri, Ujjain 456010 (MP). 21. Levozed-500 B. No.: T8209 Uniformity of Weight CDSCO, CDTL, (Levofloxacin Mfg dt: 03/2018 Sub Zone, Mumbai Tablets IP 500 mg) Exp dt: 02/2020 Indore Mfd by: M/s. Zest Pharma, Plot No. 275, Sector F, Sanwer Road, Indore-452015. 22. Ceftriaxone Sodium (Ceftriaxone Sodium and BET (Sterile Water Arunachal RDTL, 1 gm. Sulbactum Sodium) for injection) Pradesh Guwahati B. No.: CHD-7008 Mfg dt: 12/2017 Exp dt: 11/2019 Mfd by: M/s. Cotec Healthcare Pvt. Ltd. Unit-III, KH. No. 596/1, Roorkee, Dehradun Highway, Kishanpur, U.K-247667. & Sulbactam Sodium (Sterile Water for Injection) 500 mg. for Injection B. No.: A070917 Mfg dt: 12/2017Exp dt: 11/2019 Mfd by: M/s. Cotec Healthcare Pvt. Ltd. Unit-III, KH. No. 596/1, Roorkee, Dehradun Highway, Kishanpur, U.K-247667. 23. ONDANSETRON B. No.: SMT409 Dissolution Assam RDTL, TABLETS I.P.4 mg. Mfg dt: 03/2017 Guwahati Exp dt: 02/2019 Mfd by: M/s. Unicure India Ltd. C-22 & 23, Sector-3, Noida-201301. 24. Gliclazide & B. No.: TX-11255 Physical Parameter & Tripura RDTL, Metformin HCL Mfg dt: 12/2016 Disintegration Guwahati Tablets Exp dt: 11/2018 Mfd by: M/s. Legen Healthcare Plot No.20, Sector-5, Parwanoo Dist- Solan, (H.P.)-173220. 25. Montigo-L Syrup B. No.: AL-17332 Assay (Levocetirizine Mizoram RDTL, Mfg dt: 06/2017 Dihydrochloride) & Guwahati Exp dt: 05/2019 Assay (Montelukast) Mfd by: M/s. Accretion Pharmaceuticals AT & PO Chancharwadi-Vasna, Ahmedabad ( Guj). 26. Amoxycillin and B. No.: BDS180513 Assay (Amoxycillin Meghalaya RDTL, Potassium Mfg dt: 05/2018 Trihydrate) Guwahati Clavulanate Oral Exp dt: 10/2019 Suspension I.P. Mfd by: M/s. Brooks Laboratories Limited, Village-Kishanpura. Nalagarh Road Baddi, (H.P.)-174101. 27. Amoxycillin and B. No.: BDS180513 Assay (Amoxycillin Meghalaya RDTL, Potassium Mfg dt: 05/2018 Trihydrate) Guwahati Clavulanate Oral Exp dt: 10/2019 Suspension I.P. Mfd by: M/s. Brooks Laboratories Limited Vill- Kishanpura, Nalagarh Road, Baddi (H.P.)-174101. 28. Amoxytor-250 B. No.: HCB709L Assay Arunachal RDTL, Capsules Mfg dt: 11/2017 Pradesh Guwahati Exp dt: 10/2020 Mfd by: M/s. Himalaya Meditek Pvt. Ltd. Plot No. 35 & 36, Pharmacity, Selaqui, Industrial Area, Dehradun- 248197.29. S-Amlodipine B. No.: T-5317 Assay Assam RDTL, Tablets I.P. Mfg dt: 02/2017 Guwahati Exp dt: 01/2019 Mfd by: M/s. Kwality Pharmaceuticals Ltd. Nag Kalan, Majitha Road, Amritsar. 30. Metronidazole-400 B. No.: OT-1712025 Dissolution Nagaland RDTL, Tablets Mfg dt: 12/2017 Guwahati Exp dt: 11/2020 Mfd by: M/s. Oshin Laboratories Pvt. Ltd. Industrial Area, Narela Road, Piao Maniyari, Kundli- 131028 (HR). 31. Cephalexin for Dry B. No.: CP5317 Assay Meghalaya RDTL, Syrup I.P. Mfg dt: 03/2017 Guwahati Exp dt: 02/2019 Mfd by: M/s. Sunrise Remedies Pvt. Ltd. Block no. 2244, Santej, TA, Kalol, Dist- Gandhinagar, Gujarat. 32. Bromol Plus Cough B. No.: BT-190 Physical Parameter Meghalaya RDTL, Expectorant Mfg dt: 09/2017 Guwahati Exp dt: 08/2019 Mfd by: M/s. Angel Laboratories (P) Ltd, Dakshin Jagaddal, Kolkata-151. 33. Ferrous Sulphate & B. No.: B80028 Uniformity of Content Assam RDTL, Folic Acid Tablet Mfg dt: 04/2018 (Folic Acid) Guwahati I.P. Exp dt: 03/2020 Mfd by: M/s. Bochem Healthcare Pvt. Ltd. 83-84, Industrial Area, Dewas Road, Nagziri, Ujjain, M.P. 456010. 34. Albendazole Tablets B. No.: T-1774602 Misbranded Arunachal RDTL, I.P. 400 mg Mfg dt: 11/2017 Pradesh Guwahati Exp dt: 10/2019 Mfd by: M/s.Hanuchem Laboratories VPO: Manpura, Tehsil, Baddi, Dist: Solan- 173205 (H.P.).35. Iron and Folic Acid B. No.: T5214 Misbranded Nagaland RDTL, Tablets Mfg dt: 06/2017 Guwahati Exp dt: 05/2019 Mfd by: M/s. Quest Laboratories Pvt. Ltd. Plot No. 45, Sector III, Pithampur, Dist-Dhar-454773 (M.P.). 36. ZNC DT-20Tablet B. No.: G180018 Disintegration Nagaland RDTL, Mfg dt: 04/2018 Guwahati Exp dt: 03/2020 Mfd by: M/s. Vee Excel Drugs & Pharmaceuticals (P) Ltd. B-1/A, Indl. Area, GNEPIP, Kasna, Greater Noida, Gautam Buddh Nagar, U.P. 37. Calcium Citrate B. No.: CALE-27 Assay of Magnesium CDSCO RDTL, Tablets with Vitamin Mfg dt: 03/2018 Hydroxide Calculated North Zone Chandigarh Exp dt: 08/2019 D3 and Minerals as Elemental Mfd by: M/s. Matins (CALCI CARE Magnesium, Vitamin Healthcare, TABLETS) D3 Plot No-10, Sector-5 I.I.E.Sidcul, Haridwar-249 403. 38. CHLORAMPHENI B. No.: E-827 PH and the Assay of CDSCO RDTL, COL EYE DROPS Mfg dt: 04/2018 Chloramphenicol North Zone Chandigarh IP 0.5% W/V Exp dt: 03/2020 Mfd by: M/s. KWALITY PHARMACEUTICALS LTD., Nag Kalan, Majitha Road, Amritsar-India. 39. Cefpodoxime B. No.: FCPT-201 Uniformity of weight, CDSCO RDTL, Proxetil Tablets IP Mfg dt: 08/2017 Dissolution North Zone Chandigarh Exp dt: 07/2019 (EUROPOD-200 (Cefpodoxime Mfd by: M/s. Crystal TABLETS) Proxetil Calculated as Pharmaceuticals, Cefpodoxime) and the 365, Model Town, Ambala Assay of City-134003. Cefpodoxime Proxetil calculated as Cefpodoxime 40. Doxylamine, B. No.: 1710015 Disintegration CDSCO RDTL, Succinate, Mfg dt: 10/2017 North Zone Chandigarh Pyridoxine HCl Exp dt: 09/2019 Mfd by: M/s. ADROIT Tablets (IPVON PHARMACEUTICALS TABLETS) PVT.LTD. 46, Garoba Maidan, Nagpur-841. Sodium Valproate B. No.: VCR1088D Identification B Sub Zone, RDTL, Tablets 200 mg Mfg dt: 04/2018 & Baddi. Chandigarh (VAT CR 200 Exp dt: 03/2020 Assay of Valproic Mfd by: M/s. Pulse TABLETS) Acid Pharmaceuticals Pvt. Ltd., Khasra No.400, 407 and 409, Karondi, Roorkee, Uttara Khand-247667. 42. CHOLECALCIFER B. No.: BSH-1801001 Assay of CDSCO RDTL, OL SACHET Mfg dt: 01/2018 Cholecalciferol North Zone Chandigarh Exp dt: 06/2019 Mfd by: M/s. Bajaj Pharmaceuticals, 256, Sisona, Bhagwanpur, Roorkee, Distt.Haridwar- 247661 (UK)

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