NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF APRIL 2024

NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF APRIL – 2024. A. CDSCO/Central Laboratories S. Product/Drug Name Batch No. Manufa Expiry Manufactured By NSQ Result Reported N. cturing Date by CDSCO Date Laboratory Pemolate Suspension (Paracetamol, Assay of M/s. Pulse Pharma MFG. Co., S. No. Phenylephrine Paracetamol & CDL, 1 407 10/2023 09/2025 553, Lala Estate, Idar Highway Road, Hydrochloride & Phenylephrine Kolkata Savgadh, Himatnagar, Gujarat, India Chlorpheniramine Hydrochloride Maleate Suspension) M/s. Ratnatris Pharmaceuticals Pvt. Description & Senocartine Ltd., Survey No. 416, At Indrad, Tal- Particulate CDL, 2 (Levocarnitine Injection RS23049 08/2023 01/2026 Kadi, Dist. Mehsana 382715 Gujarat, Matter in Kolkata USP 1g / 5ml) India Injections M/s. Ratnatris Pharmaceuticals Pvt. Frusemide Injection IP Ltd., Survey No. 416, At Indrad, Tal- Particulate CDL, 3 RS23037 08/2023 07/2025 10mg / ml (Senfuro) Kadi, Dist. Mehsana 382715 Gujarat, Matter Kolkata India Dextromethorphan HBr, Phenylephrine M/s. Shri hari Pharmaceuticals, Assay of HCl & Vasdsar-Motibhoyan Road, Village: CDL, 4 S24B045 02/2024 01/2026 Dextromethorph Chlorpheniramine Vadsar - 382 721, Kalol District, Kolkata an Hydrobromide Maleate Syrup (DEX Gandhinagar, Gujarat HS Syrup) Page 1 of 11M/s. Karnataka Antibiotics and Ofloxacin and Pharmaceuticals Limited, Plot No-14, CDL, 5 6001523 06/2023 05/2026 Description Ornidazole Tablets IP Peenya-II, Phase, Bengalluru- Kolkata 560058, Karnataka. Ambroxol, M/s. Aurio Pharma Laboratories Pvt. Guaiphenesin, CDL, 6 BDT-1257 12/2023 05/2025 Ltd., Rabindra Sarani, Namita, Assay of Menthol Terbutaline and Kolkata Kolkata-700049 Menthol (Bromodex - T) M/s. Novo Nordisk A/S Novo Alle, Human Growth DK-2880 Bagsvaerd, Denmark, Hormone Inj. Imported by: Novo Nordisk India CDL, 7 MC76638 05/2022 04/2024 Description (Norditropin Nordiflex Prtivate Limited, Plot No. 32, 47-50, Kolkata 15mg / 1.5ml) EPIP Area, Whitefield, Bangalore- 560066, M/s. Mascot Health Series Private Cilnidipine Tablets IP CDL, 8 MT223472A 07/2022 06/2024 Limited, Plot No. 79, 80, Sector-6A, Dissolution (Cinatab -10) Kolkata IIE, SIDCUL, Haridwar 249 403. M/s. SVP Life Sciences, C/10/1, Sara Atropine Sulphate pH, Particulate CDL, 9 23UJ85 10/2023 09/2025 Industrial Estate, Selaqui, Dehradun, Injection IP Matter & Assay Kolkata Uttarakhand M/s. SVP Life Sciences, C/10/1, Sara Metoclopramide CDL, 10 23DQE20 05/2023 04/2025 Industrial Estate, Selaqui, Dehradun, Assay Injection IP 10mg / 2ml Kolkata Uttarakhand Ambroxol M/s. Jineka Healthcare Private Identification & Hydrochloride, Limited, Khasra No. 507-525, Bedpur Assay of Menthol CDL, 11 Terbutaline Sulphate, JL-231248 12/2023 11/2025 Crossing Bhagwanpur Bypass, and Assay of Kolkata Guaiphenesin Menthol Roorkee, Distt. Haridwar (U.K.) 247 Terbutaline Syrup (Luzicough-T) 667 Sulphate Page 2 of 11M/s. Mascot Health Series Private Gabapentin Tablets IP Related CDL, 12 MT225040 11/2022 10/2024 Limited, Plot No. 79, 80, Sector-6A, (Gabon-300) Substances Kolkata IIE, SIDCUL, Haridwar 249 403. M/s. Dr. Edwin Medilabs Pvt. Ltd., Promethazine DEML- Plot No. B-29, Industrial Area, Focal CDL, 13 Hydrochloride Syrup IP 02/2023 01/2025 Assay 304269 Point Chanalon, Kurali, SAS Nagar - Kolkata (Phena Kid Syrup) 140 103 (pb) Identification & Assay of CDL, Cefixime and Kolkata ★Cefixime Trihydrate Gram Positive with Lactic Acid M/s. Pragti Remedies, Plot No. 143, endospore Refer Sr No 14 Bacillus Tablets I.P. BHCJ-009 11/2022 10/2024 G. S. Road Link, Ulubari Guwahati, bearing rod 05 of (Presef-200 LB Assam-781008 shaped spurious Tablets) bacterium. alert April The sample 2024 deemed to be Spurious. M/s. Ritual Drugs Pvt. Ltd., Plot No. Telmisartan Tables IP 271-272, Phase-I, HSIIDC, Barhi Description & CDL, 15 GT3F32 06/2023 05/2025 (Telwide 80 Tablets) Industrial Area, Sonepat (HR) - 131 Dissolution Kolkata 101 Quinine Sulphate M/s. Shreya Life Sciences Pvt. Ltd., CDL, 16 Tablets IP 300 mg R22417106 09/2022 08/2024 13, 14, 15, Raipur, PO Bhagwanpur, Description Kolkata (REZ-Q* 300) Roorkee- 247 661, Uttarakhand. Page 3 of 11Cefixime Dispersible M/s. Amster Labs, Unit-II Hilltop, Ind. CDL, 17 Tablets IP (Vixif-100 SBT136B 02/2023 01/2025 Estate, Vill. Bhatauli Kalan, Baddi, Disintegration Kolkata Tablets) Dist. Solan (H.P.) Assay / Content Amoxycillin and of Gram Positive Pottasium Clavulanate M/s. Supermax Laboratories, Plot endospore CDL, 18 with Lactic Acid SEB-23122 09/2022 02/2025 No. 40, Pharmacity, Selaqui bearing rod Kolkata Bacillus Tablets Industrial Area, Dehradun - 248 011 shaped (Yamox-CL) bacterium Thyroxine Sodium M/s. Macleods Pharmaceuticals Ltd., CDL, 19 Tablets I.P. (THYROX- MTC2338A 04/2023 03/2025 Plot No. 2209, GIDC, Sarigam, Dist. Dissolution Kolkata 75) Valsad 396 155 Cyclosporine Capsules M/s. Johnlee Pharmaceuticals Pvt. RDCPH230 CDL, 20 IP 25 mg (Cycloclean- 10/2023 09/2025 Ltd., Plot No. 10, 11, Sector 6B, IIE, Water 02 Kolkata 25) SIDCUL, Haridwar, 249403 Dextromethorphan M/s. Enicar Pharmaceuticals Pvt. Hydrobromide, Ltd., Plot No. J-214, 215, 216, MIDC, Phenylephrine Tarapur, Boisar, Dist. Palghar- CDL, 21 Hydrochloride, 23CH0250 12/2023 11/2026 401506 Assay of Menthol Kolkata Chlorphenamine Maleate & Menthol Syrup (Tuspress) Description, M/s. Psychotropics India Ltd., Plot Tranexamic Acid Related ANO43004 No. 12, 12A, Industrial Park-2, CDL, 22 Injection IP 08/2023 07/2025 Substances & R Phase-1, Salempur, Mehdood-2, Kolkata (GYNAEPIL Injection) Particulate Haridwar-249403 (Uttarakhand) Matter Page 4 of 11M/s. Vidhyasha Pharmaceuticals, 28, Carvedilol Tablets IP Oct- Sep- Industrial Area, Johron Trilokpur RDTL, 23 6.25 mg (Carviv-6.5 VDT-23931 Dissolution 2023 2025 Road, Kala Amb, Distt. Sirmour, H.P.- Chandigarh TABLETS) 173030 Terbutaline Sulphate, Ambroxol, Nov- Oct- M/s. Northern India Chemical Works RDTL, 24 Guaiphenesin and S-2245 pH 2023 2025 Pvt.Ltd., V.Dantal, MRT-250001 Chandigarh Menthol Syrup (Cufrish EXPECTORANT) Assay of Clindamycin and M/s. Yaxon Biocare Pvt.Ltd., Plot No. Clindamycin Jan- Dec- RDTL, 25 Adapalene Gel (CLON- YEX-463 6, HSIIDC, Industrial Area Rai, Phosphate 2024 2025 Chandigarh A Gel) Sonipat-131029 (HR). calculated as Clindamycin Neostigmine M/s. Health Biotech Ltd., Village Mehtysulphate HINM23002 Feb- Jan- RDTL, 26 Sandoli, Nalagarh Road, Baddi, Identification (A) Injection IP (N-MINE B 2023 2025 Chandigarh Distt.Solan (H.P.) India-173205 Injection) Diphenhydramine Dissolution and M/s. Caspian Pharmaceuticals, Hydrochloride CPD240100 Jan- Dec- Assay of RDTL, 27 Mauza Ogli, Suketi Road, Kala-Amb, Capsules IP (XL Dryl-D 6 2024 2025 Diphenhydramin Chandigarh Sirmaur-173030 Capsules) e Hydrochloride Assay of Cloxacillin Sodium Oral M/s. RIDLEY LIFE SCIENCE PVT. Cloxacillin Jun- RDTL, 28 Suspension USP RD220020 Jul-2022 LTD., D-1651, DSIDC Indl.Complex, Sodium 2024 Chandigarh 125mg/5ml Narela, Delhi-110040 calculated as Cloxacillin Page 5 of 11Enteric Coated Dissolution of Rabeprazole Sodium Domperidone and Domperidone M/s. VIP Pharmaceuticals Pvt. Ltd., SCDSR240 Feb- Jan- (8th hours) and RDTL, 29 (Sustained Release) Village, Manpura, Tehsil Nalagarh, 01 2024 2026 Dissolution of Chandigarh Capsules Distt. Solan-174101 (H.P.) Domperidone (STOMCOOL DSR (12th hours) CAPSULES) AMOXYCILLIN M/s. J.R.S. ORYX TRIHYDRATE I.P. Mar- PHARMACEUTICALS (P) LTD., 217- RDTL, 30 OD-598 Apr-2023 Assay (MARKMOX ORAL 2025 218, Sector-3, H.S.I.I.D.C., KARNAL- Guwahati SUSPENSION I.P.) 132001 (India) M/s. Ridley Life Science Pvt. Ltd., D- Amoxycillin Oral Sep- Assay/Content of RDTL, 31 RD220034 Oct-2022 1651, DSIDC, Indl. Complex, Narela, Suspension IP 2024 Amoxycillin Guwahati Delhi- 110040 M/s. Swiss Garniers Biotech Pvt. Ltd., Telmisartan Tablets IP 40 Dec- RDTL, 32 189TTF002 Jan-2023 21, Industrial Area, Mehatpur, District- Dissolution mg. (Tzil 40) 2024 Guwahati Una, Himachal Pradesh-174 315, INDIA. M/s.Brilliant Lifesciences Pvt Ltd., Amlodipine Besylate Nov- Oct- CDTL, 33 1125 At Chuval Dangarwa, Ta : Detroj Dissolution Tablets IP 5 mg 2023 2026 Indore Dist: Ahmedabad (Guj) India Page 6 of 11B. STATE LABORATORIES S.N Product / Drug Batch No. Mfg Dt Exp Dt Manufactured By NSQ Results Reported By o Name CDSCO / State Lab 1 Ceftriaxone HD1607F June, 2023 May-25 M/s. Himalaya Meditek Pvt The sample fails in State Drugs Injection IP 250 mg Ltd Plot No. 35 & 36 Uniformaity of Testing (JKMSCL Hospital Pharmacity Selaqui Ind. Area weights & Laboratory Supply) Dehradun - 248197 Assay/Contents are Srinagar found less than the (Jammu & label claim Kashmir) 2 Exudase DP 03023118 Sep-23 Aug-25 M/s. Ravenbhel Healthcare The sample fails in State Drugs Pvt Ltd . 16-17, EPIP, SIDCO the test, “Description Testing Kartholi Bari Brahmana of tablets”. Laboratory Jammu -1881133 Mrk. By: Srinagar Ravenbhel Pharmaceuticals (Jammu & (P) Ltd 7-A, Baba Budha Kashmir) Avenue G.T Road Amritsar- 143001 3 Rabeprazole UTGRBB3 Aug-23 Jul-26 M/s. Khandelwal does not comply to IP State Food & Sodium Tablets IP 04 Laboratories Pvt. Ltd., Plot Standards with Drugs 20mg (RAB 20mg) No. 20, Sector-6, IIE, Sidcul, respect to dissolution Laboratory, Pantnagar, U. S. Nagar- test Bambolim, Uttarakhand, 263153 Goa Page 7 of 114 Rabeprazole CA21880 Aug-23 Jul-25 M/s. Mepro Pharmaceuticals does not conform to State Food & Sodium Tablets IP Pvt. Ltd.; (Unit II), Q Road, IP Standards with Drugs (CYRA) Phase IV, GIDC, hwan- respect to the test for Laboratory, 363035, Dist. Surendranagar, dissolution Bambolim, Gujarat. Goa 5 Metronidazole 2869A 07/23 06/25 M/s. Arco Pharma Pvt Ltd, It fails the test State Drugs Tablets IP 200 mg 1,2,3, Akshay Industrial ‘Dissolution’ as per IP Testing Estate, Vasai, Palghar (M.S) Laboratory Thiruvananth apuram, Kerala 6 Ciprofloxacin CPT 09/23 08/26 M/s. Vivek Pharmachem It fails the test State Drugs Tablets IP 500 mg 23022 (India) Ltd, NH-8, ‘Dissolution’ as per IP Testing Chimanpura, Amer, Jaipur- Laboratory 303102 Thiruvananth apuram, Kerala 7 Bimatoprost Eye CHE-3036 04/23 03/25 M/s. Cotec Healthcare It fails the test State Drugs Drops 3 ml Pvt.Ltd, K.H.No. 593/1 ‘Sterility’ as per IP Testing Roorkee , Dehradun , High Laboratory way, Kishanpur, Roorkee- Thiruvananth 247667 Uttarakhand apuram, Kerala 8 Frusemide Injection FRIA-11 11/23 10/25 M/s. Nestor Pharmaceuticals It fails the test State Drugs IP 20 mg Ltd, 11, Western Extension ‘Sterility’ as per IP Testing Area, Faridabad -121001 Laboratory Thiruvananth apuram, Kerala Page 8 of 119 Salbutamol D 2259/23- 06/23 05/25 Supplied by M/s. Kerala It fails the test Acidity State Drugs Nebuliser Solution 24 Medical services Corporation pH as per BP Testing BP Limited, Thycaud P.O, Laboratory Thiruvananthapuram Thiruvananth apuram, Kerala 10 Warfarin sodium TW250004 07/23 06/26 M/s. Centurion Remedies It fails the State Drugs Tablet IP 5 mg pvt.Ltd, G/5, G/6, Idl.Estate, ‘Description’. Testing Gorwa, Vadodara 390016 Laboratory Thiruvananth apuram, Kerala 11 Amloheart-AT LE 223030 03/23 02/25 M/s. Lividus It fails the test ‘Assay’ State Drugs [Amlodipine Pharmaceuticals pvt.Ltd, as per IP Testing Besylate and ikeva level 2, Agnito Tech Laboratory Atenolol Tablets] Park, 141, Kandanchavadi, Thiruvananth Near Perungudi, OMR, apuram, Chennai- 600096 Kerala 12 Bupivacaine D2258/23- 09/23 08/25 Supplied by M/s. Kerala It fails the test Sterility State Drugs Hydrochloride in 24 Medical services Corporation as per USP Testing Dextrose Inj. USP Limited, Thycaud P.O, Laboratory 0.50% 4 ml Amp Thiruvananthapuram Thiruvananth apuram, Kerala 13 Mucoid-A [Acetyl MTT-6856 12/23 11/25 M/s. MDC Pharmaceuticals The content of active State Drugs Cysteine & Ltd, Unit-II, sai Road, Baddi- ingredients is not Testing Ambroxol HCL 173 205 within the limits of Laboratory Tablets ] Schedule V of Drugs Thiruvananth and cosmetic act and apuram, rules there under Kerala Page 9 of 1114 Sallaki Tablets AB 23055 11/23 10/26 M/s. Gufic Biosciences The sample fails the State Drugs Limited, 703, Udayambag, test Disintegration as Testing Belgaum, Karnataka per API Laboratory Thiruvananth apuram, Kerala 15 Panion Tablets 7964 04/23 03/27 M/s. Win Trust The sample is an State Drugs Pharmaceuticals Ltd. Dugri, Ayurvedic Testing Dhandra Road, Ludhiana preparation It gives Laboratory positive result for the Thiruvananth presence of apuram, Diclofenac Sodium Kerala (Allopathic drug) and hence declared as Not of Standard Quality. The sample is a spurious drug. 16 Paracetamo L-0475 Oct-22 Sep-24 Quest laboratories Pvt. Ltd., The Sample failed in MP State lab Paediatric Oral Plot No. 45, Sector III, description reported on Suspension IP 125 Pithampur, Dist. Dhar- 454 19.04.2024 mg/ml 775 Page 10 of 1117 Paracetamo 21350 Sep-22 Aug-24 Zenith Drugs Pvt. Ltd. , 75/5, The Sample failed in MP State lab Paediatric Oral Muradpura(Orangepura), description reported on Suspension IP 250 Dhar Road , Near Kalaria, 19.04.2024 mg/ml Indore 453 001 NOTE: 1. NSQ data was not received as per Format & in EXCEL SHEET from State Drugs Licensing Authorities of Karnataka & Uttar Pradesh for the Month of April, 2024 as per DCG(I) Circular dated 09.02.2024. 2. Sate Drugs Licensing Authorities of Mizoram, Tripura, Pondicherry have stated that the NSQ data as “NIL” for the Month of April, 2024. 3. State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Assam, Bihar, Chhattisgarh, Gujarat, Haryana, Himachal Pradesh, Maharashtra, Manipur, Meghalaya, Mizoram, Nagaland, Odisha, Punjab, Rajasthan, Sikkim, Tamil Nadu, Telangana, Uttarakhand, West Bengal, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of April, 2024 as per DCG(I) Circular dated 09.02.2024. Page 11 of 11