Home India Ministry of Health and Family Welfare Drug Alert for the Month of February 2024...
Date: 2024-03-20 Category: Not Applicable State: Union Government Country: India

Drug Alert for the Month of February 2024

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

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Executive Summary & Key Takeaways

Gazette Notification Overview

  • This gazette notification lists drugs, medical devices, vaccines, and cosmetics declared as Not of Standard Quality (NSQ), Spurious, Adulterated, or Misbranded for February 2024 in India.
  • A total of 676 samples were received, and 1167 samples were tested.
  • Out of the tested samples, 1018 were declared as of Standard Quality, 58 as Not of Standard Quality, 2 as Spurious, and none as Misbranded.

Key Changes and Findings

  • 58 samples were declared as Not of Standard Quality (NSQ) due to various reasons such as disintegration issues, stability problems, assay discrepancies (Vitamin D3, Propofol, Glimepiride), uniformity of dispersion, description discrepancies, particulate matter, pH deviations, water content, dissolution failures (Clarithromycin, Rabeprazole, Montelukast Sodium), and presence of excessive Ethylene Glycol.
  • 2 samples were declared as Spurious. Both spurious samples relate to Pharm Asia Drug's Hydrogen Peroxide Topical Solution IP 6% w/v.
  • Two Telmisartan Tablets batches (Telma AM and Telma 40) manufactured by Glenmark Pharmaceuticals were reported as spurious by the company itself, pending further investigation.

Impact Analysis

Impact on Pharmaceutical Manufacturers

  • Manufacturers need to review their testing protocols and ensure compliance with pharmacopeial standards for assay, dissolution, disintegration, and other quality parameters.

Impact on Healthcare Providers and Patients

  • Increased vigilance in pharmacovigilance programs is needed to detect and report adverse drug reactions related to substandard or falsified medicines.

Impact on Regulatory Authorities

  • Strengthening of analytical laboratories with advanced equipment and trained personnel is essential for accurate and timely drug testing.

Suggested Action Items

  • Collaborate with international regulatory agencies to combat the global problem of drug counterfeiting.

Key Entities Referenced

Drugs and Cosmetics Act, 1940: The primary legislation governing the quality control and regulation of drugs, cosmetics, and medical devices in India. This gazette notification is issued under the provisions of this act. Central Drugs Standard Control Organization (CDSCO): The national regulatory authority responsible for drug regulation in India. CDSCO, along with State Drug Controllers, plays a key role in monitoring drug quality and taking action against manufacturers of NSQ and spurious drugs. State Drug Controllers: State-level regulatory authorities responsible for licensing, inspection, and enforcement of drug regulations within their respective states. They work in coordination with CDSCO to ensure drug quality. Drugs Control Laboratory: The central or state government laboratory which tests the samples drawn by Drug Inspectors.
Official Source Record View Original Source →
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List of Drugs, Medical Devices, Vaccines and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of February– 2024. Total no. of samples received - 676 Total number of samples tested - 1167 Total number of samples declared as of Standard Quality - 1018 Total number of samples declared as Not of Standard Quality - 58 Total number of samples declared as Spurious - 02 Total number of samples declared as Misbranded - NIL S.N Name of Batch No. Date of Date of Manufactured By Reason for failure Drawn By From o Drugs/medical Manufactu Expiry (From (Name of device/cosmetics re state/CDS Laboratory) CO Zone) Nexkem Biotech Pvt. Ltd., Plot No. 64, Drugs Central Acepik - P HPSIDC, Industrial Inspector, Drugs 1 (Aceclofenac and NKT230962A 05/2023 04/2025 Disintegration Area, Baddi, Distt. Ranchi, Laboratory, Paracetamol Tablets) Solan (H.P.) - 173 Jharkhand Kolkata 205. Laborate Drugs Central Amoxycillin Oral Pharmaceuticals Inspector, Drugs 2 Suspension I.P. XMSD-001 03/2023 08/2024 India Ltd., 51, Indl, Stability Ranchi, Laboratory, (Medmoxil 125) Area, Paonta Sahib Jharkhand Kolkata (H.P.) Nutra Life Healthcare Pvt. Ltd., Plot No. 44-45, Shiv Ganga Calcium Carbonate Drugs Central Industrial Estate, and Vitamin D3 Inspector, Drugs 3 NLT-17023 05/2023 04/2025 Lakeshwari, Assay of Vitamin D3 Tablets IP (Calcigiant Ranchi, Laboratory, Bhagwanpur, 500 Tablets) Jharkhand Kolkata Roorkee, Distt. Haridwar, Uttarakhand Page 1 of 12Concept Drugs Central Ofloxacin Dispersible Pharmaceuticals Ltd., Uniformity of Inspector, Drugs 4 Tablets IP 100 mg C21O062001 05/2022 04/2024 A-28/3 MIDC, Dispersion Ranchi, Laboratory, (Oflab 100 DT) Chikalthana, Jharkhand Kolkata Aurangabad-431006 Hanuchem Laboratories, Plot Drugs Central Calcium and Vitamin No. 16-17, Sector - 5, Inspector, Drugs 5 D3 Tablets IP KSWAC014 05/2023 04/2025 Assay of Vitamin D3 Indl. Area, Ranchi, Laboratory, (MAHACAL -500) Parwanoo, Dist. Jharkhand Kolkata Solan 173 220 (H.P.) Arnav Research Drugs Central Serratiopeptidase Laboratories, 435, Inspector, Drugs 6 Tablets (Serrizym AT035M 07/2023 06/2025 G.I.D.C. 2, Assay Ranchi, Laboratory, Tablet) Dediyasan, Mehsana, Jharkhand Kolkata Gujarat 384002 DWD Pharmaceuticals Ltd., Montelukast Sodium Drugs Central 308/5, Village & and Levocetirizine Inspector, Drugs 7 TXL012007 11/2022 10/2024 Post: Poicha (Rania), Desription Hydrochloride Tablet Ranchi, Laboratory, Tal Savli, Dist. IP (XL-Mont) Jharkhand Kolkata Vadodara 391780, Gujarat, India Protech Telelinks, Drugs Propofol Injection IP Central Mauza Ogli, Suketi Inspector, 500 mg/50 ml Drugs 8 L3352301A 06/2023 05/2025 Road, Kala Amb. Assay of Propofol Bilaspur, (Hyprovan 500 Laboratory, Dist. Sirmour - Himachal Injection) Kolkata 173030 (H.P.) Pradesh SAI Parenterals Limited, D1 & D4, Description, Drugs Central Heparin Sodium Survey No. 280, Extractable Volume, Inspector, Drugs 9 Injection IP 25000 22HE16 10/2022 09/2024 Phase-V, IDA, Particulate Matter and Bikaner, Laboratory, IU/5ml Jeedimetla, Assay Rajasthan Kolkata Hyderabad 500 055, Telangana, India Page 2 of 12Vilin Bio Med Ltd., Metformin HCl (SR) Unit-II, Khasra No. Central with Glimepiride & 85, Madhopur CDSCO, Drugs 10 T-230859 08/2023 07/2025 Assay of Glimepiride Voglibose Tablets Hazarathpur, Rishikesh Laboratory, (Metaglim-V2) Roorkee -247667, Kolkata Uttarakhand Orchid Bio-Tech Central Limited, 65, Clarithromycin CDSCO, Drugs 11 OT-231393 10/2023 09/2025 Peerpura-Delhi Dissolution Tablets IP 250 mg Rishikesh Laboratory, Highway, Roorkee- Kolkata 247667 (U.K.) Orchid Bio-Tech Rabeprazole Sodium Central Limited, 65, Dissolution of & Domperidone CDSCO, Drugs 12 OC-23349 11/2023 10/2025 Peerpura-Delhi Rabeprazole & Capsules (Deep SR Rishikesh Laboratory, Highway, Roorkee - Domperidone Capsules) Kolkata 247667 (U.K.) Glimepiride & Vilin Bio Med Ltd., Meftormin Unit-II, Khasra Central Hydrochloride No.85, Madhopur, Dissolution & Assay CDSCO, Drugs 13 T-231020 10/2023 09/2025 Prolonged Release Hazarathpur, of Glimepiride Rishikesh Laboratory, Tablets IP (Glimsid- Roorkee-247667, Kolkata 2MF) Uttarakhand. Pharm Asia Drug, 20-21, Panchal Central Compound, Survey Methyl Alcohol & Liquid Formaldehyde CDSCO, Drugs 14 FS-228A 08/2022 07/2025 No. 78/1, PH No. 17, Assay of 40% w/v (Formallin) North Zone Laboratory, New 45, Gram Formaldehyde 40%w/v Kolkata Lasudia Mori, Indore - 452 010 (M.P.) SGS Pharmaceutical (P) Ltd., E-13/1, Central Piroxicam Capsules IP Kavi Nagar Indl. CDSCO, Drugs 15 KCC-03 11/2023 10/2025 Water content (Piroxicam-20) Area, Sector - 17, North Zone Laboratory, Ghaziabad 201002 Kolkata (U.P.) Page 3 of 12Pharm Asia Drug, 20-21, Panchal Identification, Acidity, Central Hydrogen Peroxide Compound, Survey Non-volatile matter CDSCO, Drugs 16 Topical Solution IP HP23-021 02/2023 01/2025 No. 78/1, PH No. 17, and Assay North Zone Laboratory, 6% w/v (20 Volume) New 45, Gram (Spurious) Kolkata Lasudia Mori, Indore - 452 010 (M.P.) Beta Drugs Ltd., O/o. The Kharuni Lodhimajra Central Drugs L-Asparaginase 10000 BASL2205Y Road, Vill. Nandpur, Particulate Matter Drugs 17 03/2022 02/2024 Inspector, IU (L-ASGEN) A Baddi, Dist. Solan, (subvisible) Laboratory, Cuttack, Himachal Pradesh Kolkata Odisha. 173205 Ronam Healthcare O/o. The Central Amikacin Injection IP Pvt. Ltd. Village- Drugs Description & Drugs 18 500 mg (Amikatas 500 RV3044 08/2023 07/2025 Kalujhanda, Tehsil- Inspector, Particulate Matter Laboratory, mg) Baddi, Distt. Slolan Cuttack, Kolkata (H.P.) 174103 Odisha. Vital Healthcare Pvt. Central CDSCO, Neostigmine Injection Ltd., Plot No. H10 pH and Assay of Drugs 19 V23034 01/02/2023 31/01/2025 West Zone, IP 0.5 mg/ml and H10/1, MIDC Neostigmine Laboratory, Mumbai Satpur, Nashik. Kolkata Sunvet Healthcare, DCA, Central Tranexamic Acid Vill. Shambhuwala, Vijayawada Drugs 20 Injection I.P. SAI-14764 03/2022 02/2024 Paonta Road, Distt. pH , Andhra Laboratory, (Tranexica) Sirmour (H.P.) - Pradesh Kolkata 173001 Alkem Health Central Paracetamol Tablets Science, A unit of CDSCO, Drugs 21 IP 500 mg (Pyricool 23444042 11/2023 10/2026 Alkem Laboratories Dissolution East Zone, Laboratory, 500) Limited, Unit - 2, Kolkata Kolkata Samardung, Karek Page 4 of 12Block, P.O. Namthan, Dist. Namchi, Sikkim - 737137 Aurio Pharma Laboratories Pvt. Central Ciprofloxacin CDSCO, Ltd., 26/1/1, S.H.K.B Drugs 22 Hydrochloride Tablets 2331044 07/2023 06/2026 Dissolution East Zone, Sarani (Jawpur Laboratory, IP 500 mg Kolkata Road), Dumdum, Kolkata Kolkata- 700 074 Unicure India Ltd., Plot No. 46(B) / 49B, Central Vill. Raipur, CDSCO, Oseltamivir Oral Drugs 23 URDP1153 05/2023 10/2024 Bhagwanpur, Description East Zone, Suspension I.P. 12 mg Laboratory, Roorkee, Distt. Kolkata Kolkata Haridwar, Uttarakhand Hygeia Pharmaceuticals Ambroxol,Guaiphenes Central MFG (P) Ltd., 608, Assay of Ambroxol CDSCO, in & Terbutaline Drugs 24 BXE064 01/09/2023 31/05/2026 Dwarir Road, Hydrochloride and East Zone, Syrup (Bromex Laboratory, Dhamaitala Dakshin Terbutaline Sulphate Kolkata Expectorant) Kolkata Jagaddal, Pin - 700 151 Paracetamol, Phenylephrine Sunny Industries Central Hydrochloride, Private Limited, CDSCO, Description & Assay Drugs 25 Chlorpheniramine 002 01/09/2023 31/08/2025 23/3/1B, R.N. East Zone, of Paracetamol Laboratory, Maleate, Sodium Nandan Lane, Kolkata Kolkata Citrate and Menthol Kolkata 700 025 Syrup (SUNGESIC-C) Glenmark Lifesciences Ltd., Central Plot No. Z-103/I, Sez 4 Hydrazino benzoic CDSCO, Drugs 26 Deferasirox 82231480 02/07/2023 01/07/2027 Phase II, Dahej, Dist. acid Ahmedabad Laboratory, Bharuch - 392130, Kolkata Gujarat, India. Page 5 of 12Sun Pharmaceuticals Miconazole Nitrate Ind. Ltd., Kh. No. Central and Fluocinolone 1335-1340, Near CDSCO, Drugs 27 SXE1800A 08/2023 07/2026 Assay Acetonide Ointment EPIP- I, Vill- Bhatoli Ahmedabad Laboratory, (Zole - F) Kalan, Baddi, Distt. Kolkata Solan, H.P. 173205 Apex Formulations Pvt. Ltd., 1276, Central Trihexyphenidyl Rajpur, Ahmedabad- CDSCO, Drugs 28 Hydrochloride Tablets AR-132 06/2023 05/2025 Assay Mehsana Highway, Ahmedabad Laboratory, IP 2 mg (Ridyl) Dist. Mehsana, Kolkata Gujarat. Fanal Levosalbutamol Pharmaceuticals Sulphate, Ambroxol LLP, 67, Surbhi Central Hydrochloride, Radhe Industrial Description & Assay CDSCO, Drugs 29 Guaiphenesin and L23K015 11/2023 10/2025 Zone, Survey No. of Levosalbutamol Ahmedabad Laboratory, Menthol Syrup 60 ml 251, At. Khambha, Kolkata Syrup (HISTARED- 360311, Gujarat, LS) India Warner Hindusthan TERBUTALINE Pvt. Ltd.,. 24-85/7, SULPHATE, Sy.No.548 & 551, Assay of Bromhexine CDSCO CDTL, 30 BROMHEXINE HCl WHL-01715 Nov-2023 Oct-2025 Laxmi Narayana Hydrochloride Hyderabad Hyderabad & GUAIPHENESIN Nagar Colony, New SYRUP (NEFDYL-X) IDA, Uppal, Hyderabad-39 (TS) Zenith Drugs Pvt. Ltd., 72/5, BROMHEXINE Muradpura CDSCO, 01-Aug- CDTL, 31 HYDROCHLORIDE 31413 31-Jul-2025 (Orangpura) Dhar pH and Assay Sub Zone, 2023 Hyderabad SYRUP 4mg/5ml Road, Near Kalaria, Indore Indore 453001 (MP) India Page 6 of 12US PHARMA (I) PVT.LTD Plot No. 4, Gut No. POVIDONE-IODINE 66, H.No. 827-830, CDSCO, 01-Jun- 31-May- CDTL, 32 SOLUTION BP EVO310 Khupi Village, Near pH West Zone, 2023 2026 Hyderabad (VIDON) Kudus, Tal. Wada, Mumbai Dist. Palghar, 421312, Maharashtra, India. Dextromethorphan Hydrobromide, Household Remedies Phenylephrine Pvt. Ltd., Plot CDSCO, CDTL, 33 Hydrochloride & HRL-070 Oct-23 Sep-25 No.6/35, Dewan And Microbial Limit test West Zone, Mumbai Chlorpheniramine Sons Aliyali, Mumbai Maleate Syrup (Zist- Palghar- 401 404. D) Johnlee Pharmaceuticals Pvt Ltd., By Aagya Pantoprazole Gastro- CDSCO, Biotech Pvt. Ltd., Dissolution in buffer CDTL, 34 resistant Tablets IP T-2210131 Oct-22 Sep-25 West Zone, 1.5, Manglour- stage Mumbai (Pantojohn - 20) Mumbai saharanpur road, Manglour- 247656, Roorkee, Haridwar. Mascot Health Series Dissolution of Atorvastatin and Pvt. Lt., Plot No. CDSCO, Atorvastatin Calcium RDTL, 35 Clopidogrel Capsules MC221173 Dec-2022 Nov-2024 79,80,Sector-6A, IIE, North Zone calculated as Chandigarh (10mg/75mg) Sidcul, Haridwar- Ghaziabad Atorvastatin 249403 MICRO LABS LIMITED UNIT-III, CDSCO, Moxonidine Tablets RDTL, 36 MXDY0005 Jun-2022 May-2025 R.S.No. 63/ 3 & 4, Dissolution North Zone BP (0.3 mg) Chandigarh Thiruvander Koil, Ghaziabad Puducherry-605102 Page 7 of 12RACHIL O/o CMO Calcium Carbonate, PHARMA.., 18-19, Bilaspur Description, Vitamin D3 and L- Phase-1, Ind.Area, District- RDTL, 37 RL22070 Aug-2022 Jul-2024 Identification and Lysine Suspension Sansarpur Terrace, Bilaspur Chandigarh Assay of Vitamin D3 (Oscaid Suspension) Distt : Kangra (HP)- H.P.- 176501 174001 O/o State Magnatek Drugs Enterprises, Plot No. Assay of Potassium Cefodoxime Proxetil Controller, 74 C (II) HPSIDC Clavulanate Diluted RDTL, 38 and Potassium MBT-22012 Jun-2022 Sep-2023 H.Q. Baddi, Ind. Area Baddi, calculated as Chandigarh Clavulanate Tablets Distt. Distt. Solan (H.P.) Clavulanic Acid Solan, HP- 1732025 173205 State FDA Ofloxacin and Biologics Inc., Suketi Dissolution of Qatilgah Ornidazole Tablets IP Road, Kala-Amb, RDTL, 39 122257 Dec-2022 Nov-2024 Ofloxacin and Kargil- (Normal -OZ Distt. Sirmour (H.P.)- Chandigarh Ornidazole 194103 (UT TABLETS) 173030 Ladakh) Agron Remedies Pvt. Dissolution and Assay Ltd., Sarverkhera, CDSCO Cefuroxime Axetil of Cefuroxime Axetil RDTL, 40 JAK-20 May-2023 Arp-2025 Moradabad Road, Sub-Zone, Tablets IP 500 mg calculated as Chandigarh Kashipur-244713 Jammu Cefuroxime (Uttarakhand) SYSTOLE Ambroxol, Terbutaline REMEDIES PVT. Sulphate, LTD. Vill. Ogli, Kala Assay of Terbutaline CDSCO , RDTL, 41 Guaiphenesin and SRLK230054 Nov-2023 Oct-2025 Amb, Teh. Nahan, Sulphate Baddi Chandigarh Menthol Syrup Distt. Sirmour (H.P.)- (Tricodex A Syrup) 173030 Ambroxol M Sea hydrochloride, Pharmaceuticals (P) Terbutaline Sulphate, Ltd., Surajpur, CDSCO , RDTL, 42 NARL-0038 Nov-2023 Oct-2025 Assay of Menthol Guaiphenesin and Paonta Sahib, Baddi Chandigarh Menthol Syrup Sirmour Himachal (Bronter SYRUP) Pradesh-173001 Page 8 of 12Magma Allianz Ambroxol Laboratories Ltd., Assay of Ambroxol Hydrochloride, Vill. Guruwala, P.O. Hydrochloride and CDSCO RDTL, 43 Levosalbutamol and MAG-S-1972 Oct-2023 Sep-2025 Bhagani Sahib, Teh. Levosalbutamol Baddi Chandigarh Guaiphenesin Syrup Paonta Sahib, Distt. Sulphate calculated as (Saivent-LX Syrup) Sirmour (H.P.)- Levosalbutamol 173025 Sickcure Ambroxol Pharmaceuticals, Plot Hydrochloride, No. 52A, Industiral Ethylene Glycol (EG) Levosalbutamol CDSCO RDTL, 44 OL-032309 Mar-2023 Feb-2025 Area, Gondpur, is exceeding the Sulphate and Baddi Chandigarh Tehsil-Paonta Sahib, permissible limit Guaiphenesin Syrup Distt. Sirmour (H.P.) (KOFVON LS Syrup) 173025 Ambroxol Boffin Biotech Pvt. Hydrochloride, Ltd., Vill. Behral, Terbutaline Sulphate, CDSCO RDTL, 45 BL-36 Jul-2023 Jun-2025 Paonta Sahib, Distt. Assay of Menthol Guaiphenesin and Baddi Chandigarh Sirmour-173025 Menthol Syrup (H.P.) (AVTUS-TG SYRUP) Chlorpheniramine Assay of Maleate, Spen Formulations Chlorpheniramine Dextromethorphan Pvt. Ltd., Plot No- Maleate, CDSCO RDTL, 46 Hydrobromide and LSF-B0075 Apr-2023 Mar-2025 123, Industrial Area, Dextromethorphan Baddi Chandigarh Phenylephrine Mehatpur, Distt. Hydrobromide and Hydrochloride Syrup UNA-174315 (H.P.) Phenylephrine (Expotus-D Syrup) Hydrochloride Dextromethorphan Hyhdrobromide, Identification and Roseate Medicare, Phenylephrine Assay of Village Anji, PO Hydrochloride and Chlorpheniramine CDSCO RDTL, 47 GL2301001 Jan-2023 Dec-2024 Barog, Distt. Solan, Chlorpheniramine Maleate and Assay of Baddi Chandigarh 173211 (H.P.) Maleate Syrup Dextromethorphan INDIA (ROYCOF-DX Hydrobromide SYRUP) Page 9 of 12Terbutaline Sulphate, ESTRA Guaiphenesin, PHARMACEUTICA Assay of Ambroxol Ambroxol CDSCO RDTL, 48 6530 Feb-2023 Jan-2025 LS, Fatehgarh Hydrochloride and Hydrochloride and Baddi Chandigarh Churian Road, Menthol Menthol Syrup (Xpert- Amritsar Br. S Syrup) M Sea Pharmaceuticals (P) LEVOCETIRIZINE Assistant Ltd. (A GMP ISO HYDROCHLORIDE Director 9001: 2015 Dissolution of RDTL, 49 & MONTELUKAST MDHMT-436 Mar-2023 Feb-2025 (Food & CERTIFIED CO., Montelukast Guwahati SODIUM TABLETS Drugs) Surajpur, Paonta I.P. (Cetliv-M) Mizoram Sahib, Sirmour (H.P.)- 173001 MERCURY LABORATORIES Levocetirizine LIMITED., Unit Inspector of Dihydrochloride and Dissolution of RDTL, 50 23112703 Mar-2023 Feb-2025 No.2, Halol Baroda Drugs, Montelukast Sodium Montelukast Guwahati Road, Village: Jarod. Assam Tablets IP Tal: Waghodia, Dist: Vadodara- 391510 ANG Lifesciences DICLOFENAC India Ltd., Village Inspector of SODIUM Malkumajra, RDTL, 51 I213109 Jul-2023 Jun-2025 Description Drugs, INJECTION I.P. Nalagarh Road, Guwahati Assam 75mg/3ml Baddi, Distt. Solan- 173205 (H.P.) Tirupati Medicare Montelukast Sodium Limited, Nahan Inspector of and Levocetirizine Road, Paonta Sahib, Dissolution of RDTL, 52 MAT22030 Jun-2022 May-2024 Drugs, Hydrochloride Tablets Dist. Sirmour, Montelukast Guwahati Sikkim IP (Montas- L) Himachal Pradesh - 173 025, India. Page 10 of 12Ridley Life Science Pvt. Ltd.,, D-1651, Inspector of Pheniramine Maleate RDTL, 53 RT220422 May-2022 Apr-2025 DSIDC, Indl. Description Drugs, Tablet I.P. (APVIL) Guwahati Complex, Narela, Assam Delhi- 110040 RIDLEY LIFE SCIENCE PVT. Inspector of Pheniramine Maleate LTD., D-1651, RDTL, 54 RT220512 Jun-2022 May-2025 Description Drugs, Tablet IP (APVIL) DSIDC Indl. Guwahati Assam Complex, Narela, Delhi-110040 Levocetirizine Spen Formulations Hydrochloride & Pvt. Ltd., Plot No- Inspector of Dissolution and Assay RDTL, 55 Montelukast Sodium TSF-B1689 Apr-2023 Mar-2025 123, Industrial Area, Drugs, of Montelukast Guwahati IP Tablets (Raremont- Mehatpur, Distt. Assam LC) UNA- 174315 (H.P.) RIDLEY LIFE SCIENCE PVT. Serratiopeptidase Inspector of LTD, D-1651, Disintegration & RDTL, 56 Tablets IP 10 mg RT220358 Apr-2022 Mar-2024 Drugs, DSIDC, Indl. Description Guwahati (Serrarid-10) Meghalaya Complex, Narela, Delhi-110040 Page 11 of 12S.No Name of Batch Date Date of Manufacture Reason for Drawn By From Remarks Drugs/medical No. of Expiry d By failure (From (Name of device/cosmetics Manuf state/CDS Laboratory) acture CO Zone) 57 The actual manufacturer (as per label claim) has Glenmark informed that the Pharmaceutica Assay & impugned batch of the Telmisartan ls Ltd., Village Dissolution Central product has not been Tablets 40 mg and Kishanpura, 03/202 of CDSCO, Drugs manufactured by them Amlodipine 5 mg 05230355 02/2026 Baddi- 3 Telmisartan North Zone Laboratory, and that it is a spurious Tablets IP (Telma Nalagarh & Kolkata drug. Thus, the product is AM) Road, Tehsil Amlodipine purported to be spurious, Baddi, Distt. however, the same is Solan (H.P.) subject to outcome of further investigation. 58 The actual manufacturer Glenmark (as per label claim) has Pharmaceutica informed that the ls Ltd., Samlik impugned batch of the Marchak, Central product has not been Telmisartan 12/202 Industrial CDSCO, Drugs manufactured by them Tablets I.P. 40 mg I8220890 11/2025 Dissolution 2 Growth North Zone Laboratory, and that it is a spurious (Telma 40) Centre, East Kolkata drug. Thus, the product is Sikkim, purported to be spurious, Sikkim - however, the same is 737135 subject to outcome of further investigation. Page 12 of 12

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