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Date: 2022-03-21 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of February 2022

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 February 2022.
  • It provides details such as the name of the product, batch number, manufacturing and expiry dates, manufacturer, reason for failure, and the authority that identified the issue.

Key Changes

  • A total of 1221 samples were tested.
  • 1181 samples were declared to be of Standard Quality.
  • 39 samples were declared as Not of Standard Quality.
  • 0 samples were declared as Spurious.
  • 1 sample was declared as Misbranded.
  • The notification lists 39 products that failed quality tests, specifying the batch number, manufacturer, and reason for failure (e.g., Assay, Dissolution, Description, Sterility, pH).
  • The products listed include drugs, medical devices (Hypodermic Syringe, Intravenous Infusion Set) and cosmetics (Hand Sanitizer).
  • Failures were detected by various CDSCO zones and State Drug Control Departments.
  • Reasons for failure include issues with Assay, Dissolution, Description, Sterility, pH, Related Substances, Disintegration, and uniformity of weight, and being Misbranded.

Impact Analysis

Impact on Manufacturers

  • Action Item: Review manufacturing processes, quality control procedures, and supply chain to identify and rectify the root causes of the quality failures. Implement corrective and preventive actions (CAPA).

Impact on Consumers

  • Action Item: Issue public advisories to inform consumers about the affected products and advise them to discontinue use and seek medical advice if necessary.

Impact on Regulatory Authorities

  • Action Item: Conduct thorough investigations of the listed manufacturers and take appropriate legal action against them. Enhance collaboration between central and state drug regulatory authorities.

Impact on Pharmaceutical Supply Chain

  • Action Item: Implement robust tracking and tracing mechanisms to ensure the timely recall of substandard products. Conduct regular audits of suppliers and distributors to ensure compliance with quality standards.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. State Drug Control Departments: State-level regulatory bodies responsible for enforcing drug regulations within their respective states. RDTL: Regional Drugs Testing Laboratory IP: Indian Pharmacopoeia USP: United States Pharmacopeia
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 February – 2022. Total number of samples tested 1221 Total number of samples declared as of Standard Quality 1181 Total number of samples declared as Not of Standard Quality 39 Total number of samples declared as Spurious 0 Total number of samples declared as Misbranded 1 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. Lapril-5 (Enalapril B. No.: GA21011 Assay and CDSCO CDTL Maleate Tablets IP 5 Mfg dt: 06/2021 Dissolution West Zone Mumbai mg) Mumbai Exp dt: 05/2023 Mfd by: M/s. Ortin Laboratories Ltd., 275 & 278, (part), I.D.A., Pashamylaram- 502307, Sanga Reddy, Dist. Telangana. 2. Erythromycin EP B. No.: EB0121086A Assay CDSCO CDTL Mfg dt: 12/2021 West Zone Mumbai Mumbai Exp dt: 11/2024 Mfd by: M/s. Unimax Chemicals Pvt. Ltd., E-116, MIDC, Tarapur, Boisar, Dist. Palghar- 401506, Maharashtra. 3. Vitcal - AC (Calcium B. No.: KQ20003 Dissolution CDSCO CDL Acetate Tablets Mfg dt: 07/2020 West Zone Kolkata U.S.P.) Mumbai Exp dt: 06/2022 Mfd by: M/s. Ortin Laboratories Limited, 275 & 278 (Part) I.D.A., Pashamylaram - 502307, Sangareddy District, Telangana State, India. 4. Trypsin, Bromelain & B. No.: GT200466 Description & CDSCO CDL Rutoside Trihydrate Mfg dt: 03/2020 Disintegration West Zone Kolkata Tablets Exp dt: 02/2022 Mumbai Mfd by: M/s. Theon Pharmaceuticals Ltd.,Vill. Saini Majra , Teh. Nalagarh, Distt. Solan, Himachal Pradesh- 174101. 5. Compound Sodium B. No.: 107008 Sterility Drug Control CDL Lactate Injection IP Mfg dt: 07/2021 Department Kolkata (Ringer Lactate Odisha Exp dt: 06/2023 Injection Solution for Mfd by: M/s. Ives Injection) Drugs (India), Pvt. Ltd., Works Ghatabillod, Dist.- Dhar, H.O. 504, Chetak Centre, R.N.T. Marg, Indore, Madhya Pradesh – 452 001. 6. Secremet -1 B. No.: 210110 Assay of CDSCO CDL (Metformin Mfg dt: 02/2021 Glimepiride Hyderabad Kolkata Hydrochloride Exp dt: 01/2023 Prolonged-Release & Mfd by: M/s. Bal Glimepiride Pharma Limited, Plot Tablets I.P.) No. 1, 2, 3, & 69, Sector - 4, IIE, SIDCUL, Pantnagar, Rudrapur, Distt. Udham Singh Nagar, Uttarakhand. 7. Lactospey B. No.: LSC010 Assay of CDSCO CDL Mfg dt: 04/2020 Bifidobacteriu Hyderabad Kolkata m species Exp dt: 03/2022 Mfd by: M/s. Unique Biotech Ltd. 8. Lapril-5 (Enalapril B. No.: GA20005 Dissolution & CDSCO CDL Maleate Tablets I.P. Mfg dt: 03/2020 Assay South Zone Kolkata 5 mg) Chennai Exp dt: 02/2022 Mfd by: M/s. Ortin Laboratories Ltd., 275 & 278 (Part), I.D.A. Pashamylaram - 502307, Sanga Reddy Dist.Telangana, India. 9. Omeprazole B. No.: K0220016 Assay & CDSCO CDL Capsules I.P. 20 mg Mfg dt: 02/2020 Dissolution South Zone Kolkata Chennai Exp dt: 01/2022 Mfd by: M/s. Kausikh Therapeutics (P) Ltd., Plot No. 6 & 7, Door No. 728, Kakkanji Cross Street, Paraniputhur Road, Gerugambakkam,Chennai - 600 128. 10. Omeprazole B. No.: K0220017 Assay & CDSCO CDL Capsules I.P. 20 mg Mfg dt: 02/2020 Dissolution South Zone Kolkata Chennai Exp dt: 01/2022 Mfd by: M/s. Kausikh Therapeutics (P) Ltd., Plot No. 6 & 7, Door No. 728, Kakkanji Cross Street, Paraniputhur Road, Gerugambakkam, Chennai - 600 128. 11. Misoprostol Tablets B. No.: CHT-1086 Assay CDSCO CDL I.P. 200 mcg Mfg dt: 04/2021 South Zone Kolkata Chennai Exp dt: 03/2023 Mfd by: M/s. Cotec Healthcare Pvt. Ltd., KH. No. 593/1, Roorkee Dehradun Highway, Kishanpur, Roorkee - 247667, Haridwar, Uttarakhand, India. 12. Cetirizine Syrup I.P. B. No.: L2106027 Description & CDSCO CDL 5 mg / 5 ml – 60ml Mfg dt: 06/2021 pH South Zone Kolkata Chennai Exp dt: 05/2023 Mfd by: M/s. Hindustan Antibiotics Ltd., C-2 & C-3,Sara Industrial Estate, Rampur, Selaqui, Dehradun, Uttarakhand. 13. Zyst-P (Pantoprazole B. No.: FK21001 Dissolution CDSCO East CDL Sodium Tablets IP) Mfg dt: 03/2021 Zone Kolkata Kolkata Exp dt: 02/2023 Mfd by: M/s. Ortin Laboratories Limited, 275 & 278 (Part) I.D.A., Pashamylaram - 502307, Sangareddy District, Telangana State, India. 14. Losartan Tablets I.P. B. No.: 3800221 Dissolution CDSCO East CDL 25 mg Mfg dt: 02/2021 Zone Kolkata Kolkata Exp dt: 01/2024 Mfd by: M/s. Karnataka Antibiotics & PhamacetucialsLimited, Plot No. 14, II Phase, Peenya, Bengaluru 560058. 15. Domperidone Tablets B. No.: 2105031 Related CDSCO East CDL I.P. 10 mg Mfg dt: 05/2021 Substances Zone Kolkata Kolkata Exp dt: 04/2023 Mfd by: M/s. Adroit Pharmaceuticals Pvt. Ltd., At: 46, Garoba Maidan, Nagpur, 440008- Maharashtra. 16. Domperidone Tablets B. No.: T141001 Assay CDSCO East CDL I.P. 10 mg Mfg dt: 07/2021 Zone Kolkata Kolkata Exp dt: 06/2023 Mfd by: M/s. ANG Lifesciences India Ltd., Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan 173205, Himachal Pradesh. 17. Balgesic Plus B. No.: 200291 Assay of CDSCO East CDL (Aceclofenac & Mfg dt: 08/2021 Aceclofenac Zone Kolkata Kolkata Paracetamol Tablets) Exp dt: 07/2023 Mfd by: M/s. Bal Pharma Limited, Plot No. 1, 2, 3 & 69, Sector - 4, IIE Sidcul, Pantnagar, Rudrapur, Distt. Udham Singh Nagar, Uttarakhand, India. 18. Meropenem Injection B. No.: 4731Z002 Related CDSCO Sub- RDTL IP 500 mg Mfg dt: 02/2021 Substances Zone Baddi Chandigarh (MEROMAX Exp dt: 01/2023 INJECTION) Mfd by: M/s. Scott-Edil Advance Research Laboratories & Education Ltd. Hill Top Ind. Area Bhatoli Kalan, Baddi – 173205, Himachal Pradesh. 19. Calcium with Vitamin B. No.: GAVB0034 Assay of Drug Control RDTL D3 Tablets IP Mfg dt: 01/2021 Vitamin D3 Department Chandigarh (SHELCAL-500 and Delhi Exp dt: 12/2022 TABLETS) uniformity of Mfd by: M/s. Pure & weight Cure Healthcare Pvt. Ltd. Plot No.26A-30, Sector 8A, IIE,SIDCUL, Ranipur, Haridwar-249403 - Uttarakhand. 20. PHENYTOIN B. No.: PTS-155A pH CDSCO Sub- RDTL SODIUM INJECTION Mfg dt: 10/2021 Zone Jammu Chandigarh USP Exp dt: 09/2023 Mfd by: M/s. PUSHKAR PHARMA Bhandariwala, Kheri, Kala-Amb-173030 – Himachal Pradesh. 21. Sucralfate and B. No.: P2AWU001 Assay of Drug Control RDTL Oxetacaine Oral Mfg dt: 06/2021 Oxetacaine Department Chandigarh Suspension Pora, Kulgam, Exp dt: 05/2023 (1g, 20mg/10 ml) Jammu & Mfd by: M/s. Pharma (SUCRAMAL- O Kashmir Force Lab (Unit-II) SUSPENSION ) Plot No. 85 & 86, Industrial Area, Gondpur, Tehsil Paonta Sahib, District Sirmour, Himachal Pradesh-173205, INDIA. 22. Calcium Citrate, B. No.: T-2107091 Assay of Drug Control RDTL Vitamin D3, Mfg dt: 07/2021 Vitamin D3 Department Chandigarh Magnesium Delhi Exp dt: 12/2022 Hydroxide and Zinc Mfd by: M/s. Rivpra Tablets (PROCAL Formulation Pvt. Ltd. TABLETS) Plot No. 8, Sector-6A, I.I.E. SIDCUL, Haridwar-249403 – Uttarakhand. 23. Telmisartan 40 mg B. No.: 18200994 Assay of Drug Control RDTL and Mfg dt: 10/2020 Telmisartan Department Chandigarh Hydrochlorothiazide Delhi Exp dt: 09/2023 12.5 mg Tablets IP Mfd by: M/s. Glenmark (TELMA H TABLETS) Pharmaceuticals Ltd. Samlik, Marchak, Industrial Growth Centre, East Sikkim, Sikkim-737135. 24. CLEAR DROPS B. No.: 104 Assay of Drug Control RDTL HAND SANITIZER Mfg dt: 05/2021 Isopropyl Department Chandigarh (ETHYL) Alcohol Himachal Exp dt: 04/2023 (90%) and Pradesh Mfd by: M/s. A to Z Ethyl Alcohol Laboratories HaryanaRoad-144001. 25. STREPTOCOCCUS B. No.: CHC-1055 Assay of CDSCO North RDTL FAECALIS, Mfg dt: 11/2021 Streptococcu Zone Chandigarh CLOSTRIDIUM s faecalis Exp dt: 10/2023 BUTYRICUM, Mfd by: M/s. Cotec BACILLUS Healthcare Pvt.Ltd., MESENTERICUS N.H.No.74, Roorkee- AND LACTIC ACID BACILLUS Dehdradun Highway, CAPSULES Kishanpur, Roorkee- 247667, Haridwar Uttarakhand. 26. Sucralfate and B. No.: P2AWU002 Assay of Drug Control RDTL Oxetacaine Oral Mfg dt: 06/2021 Oxetacaine Department Chandigarh Suspension (J&K) Exp dt: 05/2023 (1g, 20mg/10ml) Mfd by: M/s. PHARMA (SUCRAMAL-O FORCE LAB (Unit-II) SUSPENSION) Plot No. 85 & 86, Industrial Area, Gondpur, Tehsil Paonta Sahib, District Sirmour, Himachal Pradesh-173205, INDIA. 27. Atorvastatin Tablets B. No.: BE9047 Dissolution Drug Control RDTL IP (OZOVAS-10 Mfg dt: 03/2021 DepartmentHima Chandigarh TABLETS) chal Pradesh Exp dt: 02/2023 Mfd by: M/s. OZONE PHARMACEUTICALS LTD. Katha, Baddi- 173205, Himachal Pradesh. 28. Esomeprazole B. No.: APT-07-0596 Dissolution Drug Control RDTL Tablets IP (ESSOF- Mfg dt: 07/2021 Department Chandigarh 20 TABLETS) (J&K) Exp dt: 06/2023 Mfd by: M/s. Adwin Pharma Vill. Rampur Jattan, Trilokpur Road, Kala-Amb, Tehsil- Nahan, Distt. Sirmour Himachal Pradesh - 173030. 29. Doxycycline and B. No.: DBQC-004 Assay of Drug Control RDTL Ambroxol Capsules Mfg dt: 10/2021 Doxycycline DepartmentHima Chandigarh (DOXYLAB chal Pradesh Exp dt: 09/2023 CAPSULES) Mfd by: M/s. LABORATEPHARMACEUTICALS INDIA LTD., 51 Indl. Area, Paonta Sahib Himachal Pradesh. 30. Sertraline B. No.: TPT-01014 Dissolution Drug Control RDTL Hydrochloride Tablets Mfg dt: 03/2021 Department Chandigarh IP 50 mg Delhi Exp dt: 02/2023 (SERTOMAX-50 Mfd by: M/s. Tanpal TABLETS) Pharmaceuticals D-12- 13, Focal Point, Nabha 147201-Punjab. 31. Hypodermic Syringe B. No.: 19556 Description & CDSCO, RDTL 2 ml Mfg dt: 06/2020 Sterility Ahmedabad Guwahati Zone Exp dt: 05/2022 Mfd by: M/s. Gurumangalam International, Rancharda-382115, (Ta: Kalol), Gujarat. 32. Hypodermic Syringe B. No.: 19554 Description & CDSCO, RDTL 2 ml Mfg dt: 03/2020 Sterility Ahmedabad Guwahati Zone Exp dt: 02/2022 Mfd by: M/s. Gurumangalam International, Rancharda-382115, (Ta: Kalol), Gujarat. 33. Omeprazole B. No.: CAG-21010 Dissolution CDSCO RDTL Capsules IP 20 mg Mfg dt: 01/2021 Sub – Zone Guwahati Guwahati Exp dt: 12/2022 Mfd by: M/s. Pro Laboratories Pvt. Ltd. 140-141, Makkanpur, Bhagwanpur, Roorkee, Dist. Haridwar- Uttarakhand- 247661. 34. Paracetamol Tablets B. No.: 19T20003 Dissolution Drug Control RDTL I.P. 500 mg Mfg dt: 07/2019 DepartmentJhark Guwahati hand Exp dt: 06/2022 Mfd by: M/s. KRAS PHARMACEUTICALS PVT. LTD. (An ISO 9001:2015 company) C-15, Industrial Area, PhaseII, Fatwah – 803201, Bihar. 35. Pantoprazole Gastro- B. No.: PFT21006MB Dissolution Drug Control RDTL resistant tablets IP Mfg dt: 05/2021 DepartmentBihar Guwahati Pantoprazole 40 mg Exp dt: 04/2023 Mfd by: M/s. Sri Ram Health Care Pvt Ltd 81-C/2 EPIP-I, Jharmajri, Baddi, Distt- Solan ,Himachal Pradesh- 173205. 36. Calcium With B. No.: T5026 Dissolution Drug Control RDTL Cholecalciferol Mfg dt: 10/2020 DepartmentAssa Guwahati Tablets I.P. m Exp dt: 03/2022 Mfd by: M/s. Tuttsan Pharma Pvt, Ltd. Plot No. 10, Block No 58, At & Post Khatraj, Taluka Kalol, Dist. Gandhinagar, Gujarat. 37. Flupentixol & B. No.: 21JP/T-1669D Misbranded Drug Control RDTL Melitracen Mfg dt: 09/2021 DepartmentAssa Guwahati Hydrochloride Tablets m Exp dt: 08/2023 Mfd by: M/s. Jips Pharmaceuticals Pvt. Ltd., Address: Not readable/ not visible/ not appeared in a conspicuous manner on the label. 38. Telmisartan Tablets B. No.: TETY-01 Dissolution Drug Control RDTL IP 40 mg Mfg dt: 04/2021 DepartmentJhark Guwahati hand Exp dt: 03/2023 Mfd by: M/s. Nestor Pharmaceuticals Limited, 11, Western Extension Area, Faridabad - 121001, Haryana, India. 39. Ranitidine Tablets IP B. No.: NSTX-11 Description CDSCO RDTL 150 mg. Mfg dt: 11/2020 Guwahati Sub- Guwahati Zone Exp dt: 10/2022 Mfd by: M/s. HINDUSTAN ANTIBIOTICS LTD. at 11. W.E.A. Faridabad-121001 Haryana.40. Intravenous Infusion B. No.: 201047 Kinking of the Drug Control RDTL Set Mfg dt: 05/2020 tubing Department Guwahati Kerala Exp dt: 04/2025 Mfd by: M/s. Lars Medicare Private Limited, Kila No. 16- 17, Sultanpur, Opp. Sports Authority of India, Near Bahalgarh Chowk, Sonepat-131021, Haryana (India).

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