CDSCO Drug Alert: 62 Drug Samples Including Mankind Pharma's Rabekind 20 Flagged
New Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 62 medicine batches for failing to qualify for a random drug sample test for the month of September.
These drug samples which are declared not of standard quality include Moxiflox-D Eye Drops, Viscoril AP, Caffeine Citrate Injection USP 60mg/3ml, Pyrazinamide-500 manufactured by Jackson Laboratories, Omeprazole Capsules IP 20 mg manufactured by Hindustan Antibiotics, Ascorbic Acid Tablets I.P. 500 mg. manufactured by ANG Lifesciences, Tobramycin Ophthalmic Solution USP 0.3% w/v manufactured by Zee Laboratories.
Apart from the above, popular drug samples such as Rabeprazole Gastro-Resistant Tablets I.P. (RABEKIND -20) manufactured by Mankind Pharma, Typhoid Polysaccharide Vaccine I.P. (TYPBAR) manufactured by Bharat Biotech International are on the list of drug samples which are 'Not of Standard Quality'.
This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1188 samples. Out of these, 1126 samples were found to be of standard quality while 62 of them were declared as Not of Standard Quality (NSQ).
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of the disintegration test, failure of the sterility test, etc.
The samples collected were tested in five laboratories, namely CDL Kolkata, CDTL Chennai, CDTL Hyderabad, RDTL Guwahati, and RDTL Chandigarh.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of September– 2023:
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of September– 2023. | |||||||||
Total number of samples tested | - 1188 | ||||||||
Total number of samples declared as of Standard Quality | - 1126 | ||||||||
The total number of samples declared as Not of Standard Quality | - 62 (03 samples for Serial No. 17) | ||||||||
The total number of samples declared as Spurious | - 0 | ||||||||
Total number of samples declared as Misbranded | - 0 | ||||||||
S.N o | Name of Drugs/medical device/cosmetics | Batch No. | Date of Manufactu re | Date of Expiry | Manufactured By | Reason for failure | Drawn By (From state/CDSCO Zone) | From (Name of Laboratory) | |
1 | Paracetamol Infusion IP -100 ML (Medmol) | TL0901L2 | Nov-2022 | Oct- 2024 | Tara Biosciences Pvt. Ltd., Plot No. E41H, RIICO Industrial Area, Khushkhera, Bhiwadi, Distt. Alwar, Rajasthan-301707 | Related substances | Drug Control Department Orissa | CDL Kolkata | |
2 | Iron and Folic Acid (IFA) Tablets I.P. (Small)(Pink) | 401 | Jan-2023 | Dec- 2024 | Deep Pharma, Khedut Sabha Building, Dholka, Ahmedabad - 382225, Gujarat. | Description & Uniformity of Content | CDSCO, Ahmedabad | CDL Kolkata | |
3 | Ascorbic Acid Tablets I.P. 500 mg (Chewable) | ACC-381 | Jun-2023 | May- 2025 | Apex Formulation Private Limited, 1276, Rajpur, Ahmedabad - Mehsana Highway, Distt. Mehsana, Gujarat | Dissolution | CDSCO, Ahmedabad | CDL Kolkata |
4 | Diclofenac Sodium Tablets IP 50 mg | AT22201 | 08/2022 | 07/202 4 | Alves Healthcare Private Limited, Nangal Uperla, Swarghat Road, Nalagarh, Dist. Solan- 174101 (H.P.). | Disintegratio n | CDSCO, South Zone | CDL Kolkata |
5 | Methylcobalamin Alphalipoic Acid, Vitamins & Minerals Capsules (ME B12 FORTE) | BPC-089 | Jul-2023 | Dec- 2024 | Bonn Schtering Biosciences, Plot No. 64 & 65, Electronic Park, Thirubuvanai, Mannadipet Commune, Puducherry - 605107 | Identification & Assay of Calcium Pantothenate and Assay of Alpha Lipoic Acid, Vitamin A Acetate & Tocopheryl Acetate | CDSCO, South Zone | CDL Kolkata |
6 | Calcium Citrate, Vitamin D3, Folic Acid, Mecobalamin & Pyridoxine Tablets (Metcanip) | BPT-512 | Jul-2023 | Dec- 2024 | Bonn Schtering Biosciences, Plot No. 64 & 65, Electronic Park, Thirubuvanai, Mannadipet Commune, Puducherry - 605107 | Description and Assay/Conte nt of Vitamin D3 | CDSCO, South Zone | CDL Kolkata |
7 | Rifampicin, Isoniazid, Pyrazinamide & Ethambutol Tablets I.P. (HRZE) | C21R772013 | Jan-2022 | Dec- 2023 | Concept Pharmaceuticals Ltd. ., A-28/3, MIDC, Chikalthana, Aurangabad - 431 006 | Assay of Rifampicin | CDSCO, South Zone | CDL Kolkata |
8 | Sodium Feredetate, Folic Acid & Vit.B12 Tablets (Zeron Tablets) | BPT-590 | Jul-2023 | Dec- 2024 | Bonn Schtering Biosciences, Plot No. 64 & 65, Electronic Park, Thirubuvanai, Mannadipet Commune, Puducherry - 605107 | Description & Uniformity of weight | CDSCO, South Zone | CDL Kolkata |
9 | Multivitamin with Ascorbic acid syrup 200ml | MVS-005 | Apr-2023 | Mar- 2025 | Medipol Pharmaceutical India Pvt. Ltd., 1199/3, Bhud, Distt. Baddi, Solan, (H.P.) | Assay of Thiamine Hydrochlorid e | CDSCO, Baddi | CDL Kolkata |
10 | Moxifloxacin & Dexamethasone Eye Drops (Moxiflox-D Eye Drops) | ED-1518 | Aug-2023 | Jul- 2025 | Jakson Laboratories Pvt. Ltd., 22-23, Majitha Road, Bye Pass, Amritsar-143001 (India) | Assay of Moxifloxacin Hydrochlorid e | CDSCO, Baddi | CDL Kolkata |
11 | Propylene Glycol IP 50 ml | OCI/PG/2023070 14 | Jul-2023 | Jun- 2028 | Organo Chem (India), G373-376, Phase-II, UPSIDC Industrial Area, M.G. Road, Hapur-245101,Uttar Pradesh, India | Water | CDSCO, Baddi | CDL Kolkata |
12 | Propylene Glycol IP 50 ml | 2023-24/2126 | Jun-2023 | May- 2028 | Manali Petrochemicals Limited, Sathangadu Village, Manali, Chennai-600068 | Water | CDSCO, Baddi | CDL Kolkata |
13 | Ambroxol HCL, Terbutaline Sulphate & Guaiphensin Expectorant (Viscoril- AP) | SY-6953 | Mar-2023 | Feb- 2025 | Jakson Laboratories Pvt. Ltd., 22-23, Majitha Road, Bye Pass, Amritsar-143001 (India) | Assay of Ambroxol Hydrochlorid e & Terbutaline Sulphate | CDSCO, Baddi | CDL Kolkata |
14 | Paroxetine Controlled Release Tablets (Proxy- CR 12.5) | ATX070647 | Jul-2023 | Jun- 2025 | Adwin Pharma,, Vill. Rampur Jattan, Trilokpur Road, Kala- Amb, Tehsil- Nahan, Distt. Sirmour, (H.P.)- 173030 | Assay and Related Substance of Paroxetine | CDSCO, Baddi | CDL Kolkata |
15 | Ambroxol HCl, Guaiphenesin, Terbutaline Sulphate & Menthol Syrup 100 ml (SKOOF) | ALX07099 | Jul-2023 | Jun- 2025 | Adwin Pharma,, Vill. Rampur Jattan, Trilokpur Road, Kala- Amb, Tehsil- Nahan, Distt. Sirmour, (H.P.)- 173030 | Assay of Ambroxol Hydrochlorid e & Terbutaline Sulphate | CDSCO, Baddi | CDL Kolkata |
16 | Caffeine Citrate Injection USP 60mg/3ml | I-5735 | Dec-2022 | Nov- 2024 | Jakson Laboratories Pvt. Ltd, 22-23, Majitha Road, Bye Pass, Amritsar-143 001 (India) | Sterility & Bacterial Endotoxins | CDSCO, Baddi | CDL Kolkata |
17 | Pyrazinamide Tablets IP 500mg (Pyrazinamide-500) | T-5969 | Dec-2022 | Nov- 2024 | Jackson Laboratories Pvt. Ltd, 22-24, Majitha Road, Bye Pass, Amritsar-143 001 (India) | Dissolution | CDSCO East Zone | CDL Kolkata |
18 | Omeprazole Capsules IP 20 mg | C22G004 | Jul-2022 | Jun- 2024 | Hindustan Antibiotics Ltd., At: B-1/11, B- 2/1, MIDC, Industrial Area, Butibori, Nagpur- 441122, Maharashtra (India) | Dissolution & Loss on Drying | CDSCO East Zone | CDL Kolkata |
19 | Amikacin Sulphate Injection IP | 23AM01 | Mar-2023 | Feb- 2025 | SAI Parenterals Limited,, D1 & D4, Survey No. 280, Phase - V, IDA, Jeedimetla, Hyderabad, 500055, TS | Description & Particulate Matter | CDSCO East Zone | CDL Kolkata |
20 | Mefenamic Acid & Paracetamol Suspension (Varnmic- P) | SL-234 | Aug-2023 | Jul- 2025 | SB Lifesciences, Plot No.32, Sector-6, IIE, Pantnagar, Distt.- U.S. Nagar (Uttarakhand)- 263153 | Assay of Mefenamic Acid | CDSCO, Sub- Zone, Rishikesh | CDL Kolkata |
21 | Monopropylene Glycol USP | 9219516033 | 16-Mar- 2023 | 15- Mar- 2025 | Shell Eastern Chemicals (S), The Metropolis Tower 1, 9 North Buona Vista Drive #07 01, Singapore 138588 | Water | CDSCO, Sub-Zone, Rishikesh | CDL Kolkata |
22 | Paracetamol Chlorpheniramine Maleate & Phenylephrine Hydrochloride Suspension (GBCOLD) | SL-247 | Aug-2023 | Jul- 2025 | SB Lifesciences, Plot No. 32, Sector-6, IIE, Pantnagar, Distt. U.S. Nagar (Uttarakhand) 263153 | Assay of Phenylephrin e Hydrochlorid e | CDSCO Sub-Zone Rishikesh | CDL Kolkata |
23 | Calcium Citrate, Magnesium, Zinc & Vitamin D3 Tablets (Jadical) | JT-037 | May-2023 | Apr- 2025 | Tosc International Private Limited, H- 1429, 1441, DSIDC Industrial Area, Narela, Delhi-110040 | Assay of Vitamin D3 | CDSCO, North Zone, Ghaziabad | CDL Kolkata |
24 | Paracetamol and Diclofenac Tablet (Panoxa Tablets) | MT23114 | Apr-2023 | Mar- 2026 | Mednext Biotech Limited, Araji No. 1845-46-47, Near Jain Temple, Iswal, Udaipur - 313011 (India) | Dissolution | CDSCO, North Zone, Ghaziabad | CDL Kolkata |
25 | POVIDONE-IODINE SOLUTION (Povidone Iodine Solution USP 10 % w/v), 200 ml | MBE-087 | Nov-2022 | Oct- 2025 | Mednext Biotech Limited, Araji No. 1845-46-47, Near Jain Temple, Iswal, Udaipur- 313011 (India) | pH & Assay/conten t of available Iodine | CDSCO, North Zone, Ghaziabad | CDL Kolkata |
26 | Levocarnitine Injection USP (Kramofit) | A2LV03A | Mar-2023 | Feb- 2025 | Lenus Lifecare Pvt. Ltd., Plot No. 1, Industrial Area, Chambaghat, Solan (H.P.) 173213 (India) | Description & Particulate Matter | CDSCO, Hyderabad | CDL Kolkata |
27 | Norfloxacin Tablets IP 400 mg | NRT23002 | Jan-23 | Dec-24 | Vivek Pharmachem (India) Ltd., NH-8, Chimanpura, Amer, Jaipur-303 102 | TEST FOR DISSOLUTI ON | CDSCO Bangalore | CDTL Chennai |
28 | Norfloxacin Tablets IP 400 mg | NRT22009 | Dec-22 | Nov-24 | Vivek Pharmachem (India) Ltd., NH-8, Chimanpura, Amer, Jaipur-303 102 | TEST FOR DISSOLUTI ON | CDSCO South Zone Chennai | CDTL Chennai |
29 | METRONIDAZOLE ORAL SUSPENSION BP (INFINITY METRONIDAZOLE SUSPENSION) | 0110 | Aug-2023 | Jul- 2026 | Lexine Technochem Pvt. Ltd., Survey No.373, Opp. Ramakaka Deri, Chhani, Vadodara, Dist: Vadodara, 391740, India | Weight per ml and Assay | CDSCO, Ahmedabad | CDTL, HYDERABA D |
30 | CALCIUM CARBONATE TABLETS IP 500 mg. | PT-30625 | Apr-23 | Mar-25 | Pharmaroots Healthcare, Khasra No. 411, Village Tipra, P. O. Barotiwala, Tehsil Baddi, Distt. Solan, H.P. | Disintergrati on | Drug Control Department Arunachal Pradesh | RDTL, Guwahati |
31 | Ciprofloxacin Hydrochloride Tablets I.P. 500mg | 0700423 | Feb-23 | Jan-25 | KARNATAKA ANTIBIOTICS AND PHARMACEUTICALS LIMITED, (A Govt. of India Enterprise) Plot No. 14, II Phase, Peenya, Bengaluru- 560058 | Dissolution | CDSCO, Guwahati | RDTL, Guwahati |
32 | Paracetamol, Phenylephrine Hydrochloride & Cetirizine Hydrochloride Tablets (PHS NCOLD PLUS) | 22GT048 | Mar-22 | Feb-25 | Accent Pharmaceuticals & Diagnostics, Vilage. Bhalon (Seri), Forest Road, Solan-173212 (H.P.) | Description | Drug Control Department Jharkhand | RDTL, Guwahati |
33 | Montelukast & Levocetirizine Dihydrochloride Tablets I.P. (Lexzin-MK) | LXMKT415 | Feb-23 | Jan-25 | Tulbros Formulations, Plot No.91, Sector- IIDC, IIE, Pantnagar, SIDCUL, Dist.U.S.Nagar-263153 (Uttarakhand) | Dissolution of Montalukast | Drug Control Department Jharkhand | RDTL, Guwahati |
34 | Rabeprazole Gastro- Resistant Tablets I.P. (RABEKIND-20) | H2IAV013 | Nov-22 | Oct-24 | Mankind Pharma, Ltd., Doring Block, Bermiok Elaka, South Sikkim- 737126 | Dissolution of Rabeprazole Sodium in Acid Phase | Drug Control Department Jharkhand | RDTL, Guwahati |
35 | Rabeprazole Gastro- Resistant Tablets I.P. 20 mg.(Robijack 20 mg.), | T-6670 | Mar-23 | Feb-25 | Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar-143001 (India) | Dissolution | Drug Control Department Bihar | RDTL, Guwahati |
36 | ASCORBIC ACID TABLETS I.P. 500 mg. | T392019 | Mar-22 | Feb-24 | ANG Lifescience India Ltd,Village Malkumajra, Nalagarh Road, Dist Solan- 173205(H.P) | Description | Drug Control Department Assam | RDTL, Guwahati |
37 | LEVOCETIRIZINE HYDROCHLORIDE TABLETS I.P. 5 mg. (Alocet) | 2303117 | Mar-23 | Feb-26 | ABAN PHARMACEUTICALS, Plot No. 1018, Kerala, G.I.D.C. Bavla, Dist, Ahmedabad-382220 | Assay /Content of Levocetirizin e | Drug Control Department Jharkhand | RDTL, Guwahati |
Hydrochlorid e | ||||||||
38 | Pantoprazole Tablets I.P. (POP CARE-40), | ET-22047 | Apr-23 | Mar-24 | Events Corporation, UNIT-II, Nahan Road, Kala Amb, Dist. Sirmour(H.P.)-173030 | Dissolution of Pantoprazole in Acid stage | Drug Control Department Jharkhand | RDTL, Guwahati |
39 | Paracetamol Tablets I.P. 500 mg. (Galpara) | GPT22001 | July-2022 | Jun-25 | Galpha Laboratories Limited, Village-Thana, Baddi, Himachal Pradesh-173205 | Dissolution | Drug Control Department Meghalaya | RDTL, Guwahati |
40 | Norfloxacin and Tinidazole Tablets (Mt- Nor-TZ), | MTZ22-222 | Aug-22 | Jul-24 | ORNATE LABS PVT. LTD., Bela Industrial Estate, Muzaffarpur- 842005 | Content of Norfloxacin and Tinidazole (ASSAY) | Drug Control Department Jharkhand | RDTL, Guwahati |
41 | ALBENDAZOLE TABLETS I.P. 400 mg. (ZENTO 400) | VGT220151 | Oct-22 | Sep-25 | VAPI CARE PHARMA PVT. LTD., PLOT NO. 225/3, NEAR MORARJI CIRCLE, GIDC VAPI, DIST. VALSAD-396195 GUJARAT, INDIA | Dissolution of Albendazole | Drug Control Department Jharkhand | RDTL, Guwahati |
42 | Ascorbic Acid Tablets I.P. 500 mg. | T392017 | Mar-22 | Feb-24 | ANG Lifesciences India Ltd., Village Malkumajra, Nalagarh Road, Baddi, Dist. Solan-173205(H.P.) | Description | Drug Control Department Assam | RDTL, Guwahati |
43 | RABEPRAZOLE SODIUM GASTRO-RESISTANT TABLETS IP (RABIRIV-20 TABLETS) | CCT22065A | Aug-22 | Jul-24 | CENT CURE PVT. LTD., PLOT NO. 71, DIC INDUSTRIAL AREA, VILL. LODHIMAJRA, DIST.SOLAN (H.P.)- 173205 | Assay of Rabeprazole Sodium | Inspector of Drugs, Jharkhand | RDTL, Guwahati |
44 | VITAMIN C TABLETS I.P. 500 mg.(XTRA-C), | XTR-2112 | Oct-21 | Sep-25 | Ridley Life Science Pvt. Ltd., D-1651, DSIDC Indl. Complex, Narela, Delhi-110040 | Uniformity of Weight | CDSCO, Sub Zone Guwahati | RDTL, Guwahati |
45 | PARACETAMOL TABLETS I.P. 500 mg., (Galpara) | GPT22002 | July-2022 | Jun-25 | Galpha Laboratories Limited, Village-Thana, Baddi, Himachal Pradesh-173205 | Dissolution | CDSCO, Sub Zone Guwahati | RDTL, Guwahati |
46 | Diltiazem Tablets IP 30 mg | GM22021 | Apr-22 | Mar-24 | Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate Puhana Iqbalpur Road, Roorkee- 247667 | Related Substances | CDSCO West-Zone Mumbai | CDTL Mumbai |
47 | Doxycycline Hydrochloride with Beta Cyclodextrin Tablets (Doxilac-B) | DBB23003 | May-23 | Apr-25 | Danish Health Care (P) Ltd., 76/27-28, Industrial Estate, Maxi Road, Ujjain - 456 010 | Description | CDSCO Indore | CDTL Mumbai |
48 | Telmisartan and Amlodipine Tablets IP | MS1AJ2302 | Feb-23 | Jan-26 | MAXTAR BIO-GENICS, Khasra No. 705, Vill. Malku Majra, Nalagarh Road, Baddi, Distt. Solan-173205 (H.P.)- India | Assay of Amlodipine Besilate equivalent to Amlodipine | Drug Control Department Himachal Pradesh | RDTL, Chandigarh |
49 | Calcium Citrate Tablets USP | T19386 | Feb-23 | Jan-25 | Quest Laboratories Pvt. Ltd., Plot No. 45, Sector-III, Pithampur, Dist. Dhar-454775 (M.P.) | Disintegratio n test and Assay of Calcium Citrate calculated as Elemental Calcium | Drug Control Department Uttar Pradesh | RDTL, Chandigarh |
50 | Tobramycin Ophthalmic Solution USP 0.3% w/v | 1223-108 | Apr-23 | Mar-25 | Zee Laboratories Ltd, Behind 47,Industrial Area, Paonta Sahib- 173025 | Identification and Assay of Tobramycin Sulphate, pH and Minimum filled volume | CDSCO Sub-Zone Jammu | RDTL, Chandigarh |
51 | Paracetamol Tablets IP 650 mg (Parasan 650 Tablets) | T-3779 | Jan-23 | Dec-24 | Redic Labs, Plot No 38, Sector-6A, SIDCUL, Haridwar (UK) | Dissolution test | Drug Control Department Uttar Pradesh | RDTL, Chandigarh |
52 | Mefenamic Acid and Dicyclomine Hydrochloride Tablets IP (MEFSAN-SPAS TABLETS) | MT-22202 | Jul-22 | Jun-24 | Medimark Drugs & Pharmaceuticals, Plot No. 39, Sector 6A, I.I.E., SIDCUL Haridwar-249403 (U.K.) | Dissolution of Dicyclomine Hydrochlorid e | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
53 | Telmisartan Tablets IP 40 mg | RT230014 | Jan-23 | Dec-24 | RIDLEY LIFE SCIENCE PVT. LTD, D-1651, DSIDC, Indl. Complex, Narela, Delhi-110040 | Dissolution and Assay of Telmisartan | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
54 | Ondansetron Tablets IP | UP2212192 | Dec-22 | Nov-24 | ADROIT PHARMACEUTICALS PVT. Ltd., At: 46, Garoba Maidan, Nagpur-8 (M.S.) | Dissolution Test | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
55 | Isosorbide Mononitrate Tablets IP 20 mg | RT220347 | Apr-22 | Mar-24 | RIDLEY LIFE SCIENCE PVT. LTD, D-1651, DSIDC, Indl. Complex, Narela, Delhi-110040 | Dissolution and Assay of Diluted Isosorbide Mononitrate Calculated as Isosorbide Mononitrate | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
56 | Calcium and Vitamin D3 Tablets IP | T179290 | Jan-23 | Dec-24 | Quest Laboratories Pvt. Ltd., Plot No. 45, Sector-III, Pithampur, Dist. Dhar-454775 (M.P.) | Assay of Vitamin D3 | CDSCO, North Zone, Ghaziabad | RDTL, Chandigarh |
57 | Simethicone, Aluminium Hydroxide and Magnesium Hydroxide Suspension (Gastro-Gel Antacid) | 8881 | Oct-21 | Sep-23 | RAMSON REMEDIES, 186-187, Ind. Focal Point, Amritsar | Description and pH | Drug Control Department Ladakh Dambuchan Leh | RDTL, Chandigarh |
58 | Povidone-Iodine Ointment USP 5% w/w | P1027 | Aug-22 | Jul-25 | Babu Ram Om Prakash (BROP), Trilokpur Road, Ogli Village, Kala Amb, Himachal Pradesh-173030, India | Assay of Povidone Iodine calculated as Available Iodine | Drug Control Department Uttar Pradesh | RDTL, Chandigarh |
59 | Zinc Sulfate Tablets USP (ZINFATE TABLETS) | ZFET2205 | Sep-2022 | Aug- 2024 | YASH PHARMA LABORATORIES PVT.LTD., At: Khasra No. 19-M, Village- Raipur, Pargana- Bhagwanpur, Tehsil- Roorkee, Dist.Haridwar, Uttarakhand-247667. | Disintegratio n test | Drug Control Department Ladakh Dambuchan Leh | RDTL, Chandigarh |
60 | Typhoid Polysaccharide Vaccine I.P. (TYPBAR) | 54A22001A | Apr-2022 | Mar- 2025 | Bharat Biotech International Limited, Genome Valley, Shamirpet Mandal, Medchal District- 500076, Telangana, India | Content of O-acetyl | Drug Control Department, Goa | CDL, Kasuali |
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