CDSCO Drug Alert: 61 Drug Samples Including Emcure's Levocarnitine Inj Flagged
New Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 61 medicine batches for failing to qualify for a random drug sample test for the month of October.
These drug samples which are declared not of standard quality include Cefixime Oral Suspension IP manufactured by Maxmed Lifescience, Amoxycillin, Potassium Clavulanate and Lactic Acid Bacillus Tablets manufactured by Soft Touch Pharmaceuticals, Fluconazole Tablets manufactured by Bonsai Pharma, Leucovorin Calcium Injection manufactured Affy Parenterals and others.
Apart from this, the list further includes Bisoprolol Fumarate Tablets USP 2.5 mg (BISELECT 2.5) manufactured by Intas Pharmaceuticals, Levocarnitine Injection U.S.P. (REE) manufactured by Emcure Pharmaceuticals.
This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1105 samples. Out of these, 1044 samples were found to be of standard quality while 61 of them were declared as Not of Standard Quality (NSQ).
A few of the reasons why the drug samples tested failed were the presence of the water content, failure of the assay, failure of the dissolution test etc.
The samples collected were tested in five laboratories, namely RDTL Chandigarh, CDTL Mumbai, CDL Kolkata, RDTL Guwahati and CDTL Hyderabad.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of October– 2023. | ||||||||
Total number of samples tested | - 1105 | |||||||
Total number of samples declared as of Standard Quality | - 1044 | |||||||
Total number of samples declared as Not of Standard Quality | - 61 (02 samples for Serial No. 4 & 02 samples for Serial No. 43) | |||||||
Total number of samples declared as Spurious | - 0 | |||||||
Total number of samples declared as Misbranded | - 0 | |||||||
S.No | Name of Drugs/medical device/cosmetics | Batch No. | Date of Manufacture | Date of Expiry | Manufactured By | Reason for failure | Drawn By (From state/CDSCO Zone) | From (Name of Laboratory) |
1 | Cefixime Oral Suspension IP | 23CS012 | Feb-2023 | Jan-2025 | MAXMED LIFESCIENCES PVT.LTD., Plot No.54, & 55 Sector-IIDC, SIDCUL, Rudrapur, (Uttarakhand) India | Water content | CDSCO (North Zone), Ghaziabad | RDTL, Chandigarh |
2 | Amoxycillin, Potassium Clavulanate and Lactic Acid Bacillus Tablets (GAMPCLAV-625 LB Tablets) | BT-000142 | Oct-2022 | Mar-2024 | Soft Touch Pharmaceuticals India Ltd., Plot No.8, Industrial Area, Waknaghat, Distt, Solan (H.P.)-173234 | Assay of Potassium Clavulate Diluted eq. to Clavulanic Acid | State FDA, District Bilaspur H.P.- 174001 | RDTL, Chandigarh |
3 | Fluconazole Tablets IP (Aclohix-400 Tablets) | MAY 23142 | May-2023 | Apr-2025 | Bonsai Pharma, Kishanpura, Baddi- Nalagarh Road, P.O.Gurumajara, Distt. Solan (H.P.) | Dissolution | O/o State Drugs Controller, H.Q. Baddi, Distt. Solan, HP-173205 | RDTL, Chandigarh |
4 | Unlabeled vials with white seal purported to contains Tigecycline 50 mg | Unlabeled | NM | NM | Affy Parenterals, at Village Gullarwala, Sai Road, Baddi, Distt. Solan (H.P.) | Assay of Tigecycline | CDSCO Sub Zone Baddi | RDTL, Chandigarh |
5 | Leucovorin Calcium Injection IP (Medivorin Injection) | LCL0322A1 | Mar-2022 | Feb-2024 | Affy Parenterals, at Village Gullarwala, Sai Road, Baddi, Distt. Solan (H.P.) | Extractable volume, Particulate matter and pH | CDSCO Sub Zone Baddi | RDTL, Chandigarh |
6 | Digoxin Injection BP (Digiver Injection) | E1582203 | Jul-2022 | Jun-2024 | Verve Human Care Laboratories, 15-A, Pharmacity, Selaqui, Dehradun-248011 (Uttarakhand) INDIA | Ethylene Glycol and Diethylene Glycol | CDSCO Sub Zonal Office Rishikesh, Uttarakhand | RDTL, Chandigarh |
7 | Rabeprazole Sodium (Enteric Coated) and Domperidone (Sustained Release) Capsules (20 mg/30 mg) | RPE-2285 | Aug-2022 | Jul-2024 | Apple Formulation Private Limited, Plot No. 208, Kishanpur, Roorkee- 247667 (UK) | Assay of Rabeprazole Sodium | CDSCO (North Zone), Ghaziabad | RDTL, Chandigarh |
8 | Aceclofenac, Paracetamol and Serratiopeptidase Tablets (Pain Free-SP Tablets) | UTA-22350 | Aug-2022 | Jul-2024 | UPKAR PHARMACEUTICALS, 101, Industrial Area, Gondpur, Paonta Sahib, Distt. Sirmour (H.P.) 173205 | Assay of Serratiopeptidase | O/o Drugs Control Officer, District Kargil Qatligarh Kargil-194103 (UT Ladakh) | RDTL, Chandigarh |
9 | Propylene Glycol IP | PG-IP/2021- 22/2331 | Nov-2021 | Oct-2026 | Manali Petrochemicals Limited, Plant II, Sathangadu Village, Manali,Chennai-600068 | Identification A, Identification B, Identification C, Relative Density, Refractive Index, Ethylene Glycol and Diethylene Glycol and Water Content | State FDA, O/o CMO, Solan, Distt.Solan (HP)-173212 | RDTL, Chandigarh |
10 | Diclofenac Sodium Tablets IP 50 mg | DBE14 | Mar-2023 | Feb-2025 | RPL (INDIA) Pharmaceuticals Pvt. Ltd., WHO-GMP CERTIFIED COMPANY D-8/5 & D- 8/6, Okhla Insutrial Area, Phase-1, New Delhi- 110020 | Description | CDSCO (North Zone), Ghaziabad | RDTL, Chandigarh |
11 | Calcium Carbonate and Vitamin D3 Tablets IP (Calimed Tablets) | LV22HT-863 | Aug-2022 | Jan-2024 | L.V.LIFE SCIENCES, VPO Gurumajra, Baddi, Distt. Solan (H.P.)- 174101 | Assay of Vitamin D3 | State FDA, District Bilaspur H.P.- 174001 | RDTL, Chandigarh |
12 | Glimepiride Tablets IP 1 mg | GPG-531 | Apr-23 | Mar-25 | Healers Lab, Unit II, Plot No.33, H.P.S.I.D.C., Extn., Baddi, Distt. Solan (H.P.) | Dissolution | CDSCO, Zonal- Office, Ahmedabad | CDTL- Mumbai |
13 | Etamsylate Tablets 250 mg (Fixoheam-250) | WF123001G | Mar-23 | Feb-25 | Windlas Biotech Limited., (Plant-2), Khasra No 141 to 143 & 145, Mohabewala Industrial Area, Dehradun- 248110, Uttarakhand | Hardness | CDSCO, West- Zone, Mumbai | CDTL- Mumbai |
14 | Albendazole Tablets I.P. 400 mg | C21F943011 | Aug-23 | Jul-26 | Concept Pharmaceuticals Ltd., A-28/3, MIDC, Chikalthana, Aurangabad- 431 006. | Dissolution | CDSCO, West- Zone, Mumbai | CDTL- Mumbai |
15 | Isoniazid Tablets IP 300 mg (Isocon -300) | C21I263005 | Jul-23 | Jun-27 | Concept Pharmaceuticals Ltd., A-28/3, MIDC, Chikalthana, Aurangabad- 431 006. | Assay | CDSCO, West- Zone, Mumbai | CDTL- Mumbai |
16 | Ofloxacin & Ornidazole Tablets I.P. (O2) | E20512 | 04/2022 | 03/2025 | Medley Pharmaceuticals Ltd., Lane No.3, Phase- 1, SIDCO Industrial Complex, Bari Brahmana, Jammu - 181 133. | Description | State FDA, Odisha, Sambalpur Range, Odisha | CDL, Kolkata |
17 | Vancomycin Hydrochloride for Intravenous Infusion IP (Sosvanco Injection) | HIVC23001A | 01/2023 | 12/2024 | Health Biotech Ltd., Village Sandoli, Nalagarh Road, Baddi, Distt: Solan (H.P.) India- 173205. | Description, Appearance of Solution, Clarity of Solution & Particulate Matter | State FDA, Odisha, Balangir Range, Balangir, Odisha | CDL, Kolkata |
18 | Adrenaline Bitartrate Injection I.P. (ADREN) | MDN2302A | 04/2023 | 03/2024 | Medilife Health Sciences Pvt. Ltd., At- Surajpur, Paonta Sahib, Dist.- Sirmour (H.P.)- 173001. | Description & Particulate Matter | State FDA, Odisha, Cuttack I Range, Odisha | CDL, Kolkata |
19 | Unlabeled bottles purported to contain Amoxycillin 200 mg and Clavulanic acid 28.5 mg | Unlabeled | Not Mentioned | Not Mentioned | Affy Parenterals, At: Vill. Gullerwala, Sai Road, Baddi, Distt. Solan (H.P.) | Content of water | CDSCO, Baddi | CDL, Kolkata |
20 | Levetiracetam Oral Solution IP | RL230004 | 01/2023 | 12/2024 | Ridley Life Sciences Pvt. Ltd., Unit II: D- 1566, DSIDC, Indl. Complex, Narela, Delhi- 110040. | Description | CDSCO, Baddi | CDL, Kolkata |
21 | Unlabeled unpacked soft gelatin capsules purported to contain Vitamin D3, 60000 IU | Not Mentioned | Not Mentioned | Not Mentioned | Affy Parenterals, At: Vill. Gullerwala, Sai Road, Baddi, Distt. Solan-173205 (H.P.) | Assay of Vitamin D3 | CDSCO, Baddi | CDL, Kolkata |
22 | Aceclofenac & Paracetamol Oral Suspension (SIGAFENAC-P) | L3C152 | 03/2023 | 02/2025 | Smayan Healthcare Pvt. Ltd., Plot No. 26-27, HPSIDC Ind. Area, Vill. Davni, Baddi, Distt. Solan, H.P. - 173205 | Assay of Aceclofenac & Paracetamol | CDSCO, Baddi | CDL, Kolkata |
23 | Cholecalciferol Soft Gelatin Capsules 60000 IU (Fexit-D3) | PSG23161 | 07/2023 | 06/2025 | Affy Parenterals, (WHO- cGMP/ ISO 9001: 2015 Certified Co.), Vill. Gullerwala, PO- Baddi, Distt. Solan -173205 (H.P.) | Assay of Cholecalciferol | CDSCO, Baddi | CDL, Kolkata |
24 | Amikacin Injection IP 100 mg (AMICOS-100) | L-22058B | 03/2023 | 02/2025 | Symbosis Pharmaceuticals Pvt. Ltd., Suketi Road, Kala Amb Distt. Sirmour, Himachal Pradesh - 173030 | Description, Sterility & Particulate Matter | CDSCO, Baddi | CDL, Kolkata |
25 | Ambroxol HCl, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup (Toscof- TR) | L3H148 | 08/2023 | 07/2025 | Smayan Healthcare Pvt. Ltd., Plot No. 26-27, HPSIDC Indl. Area, Vill. Davni, Baddi, Distt. Solan, H.P. - 173205 | Assay of Menthol | CDSCO, Baddi | CDL, Kolkata |
26 | Ofloxacin, Ornidazole, Itraconazole & Clobetasol Propionate Cream (Derma-RX Cream) | E3H021 | 08/2023 | 07/2025 | Smayan Healthcare Pvt. Ltd., Plot No. 26-27, HPSIDC Indl. Area, Vill. Davni, Baddi, Distt. Solan, H.P. - 173205 | Assay of Clobetasol Propionate | CDSCO, Baddi | CDL, Kolkata |
27 | Etoricoxib & Thiocolchicoside Tablets (ATOCOX-MR Tablets) | DMT1202B | 08/2023 | 07/2025 | DM Pharma Private Limited (WHO GMP & ISO APPROVED), NH- 21A, Vill. Bhud, Baddi, District Solan, (H.P.) 173205. | Assay of Thiocolchicoside | CDSCO, Baddi | CDL, Kolkata |
28 | Pregabalin & Methylcobalamin Capsules IP | CHC-3062 | 08/2023 | 07/2025 | Cotec Healthcare Pvt. Ltd., NH No. 74, Roorkee Dehradun Highway, Kishanpur, Roorkee - 247667, (Uttarakhand). | Uniformity of content of Methylcobalamin | CDSCO, Sub- Zone, Rishikesh | CDL, Kolkata |
29 | Rabeprazole Sodium (EC) and Domperidone (SR) Capsules (Rabihal DSR Capsule) | ZCN3G04 | 07/2023 | 06/2025 | Zaneka Healthcare Ltd., BHEL Ancillary Estate, Ranipur, Haridwar- 249403 (U.K.) | Dissolution of Rabeprazole Sodium (Buffer Stage) | CDSCO, Sub- Zone, Rishikesh | CDL, Kolkata |
30 | Vitamin C (Orange Syrup) | MBL-063 | 09/2022 | 08/2024 | Mednext Biotech Limited, Araji No. 1845-46-47, Near Jain Temple, Iswal, Udaipur - 313011 (India). | Assay of Ascorbic Acid | CDSCO, North Zone | CDL, Kolkata |
31 | Cough Syrup (ANYKOF) | ML23073 | 05/2023 | 04/2026 | Mednext Biotech Limited, Araji No. 1845-46-47, Near Jain Temple, Iswal, Udaipur - 313011 (India). | Assay of Bromhexine Hydrochloride & Menthol | CDSCO, North Zone | CDL, Kolkata |
32 | Bisoprolol Fumarate Tablets USP 2.5 mg (BISELECT 2.5) | V2300382 | 04/2023 | 03/2025 | Intas Pharmaceuticals Ltd., 7/3, GIDC Estate, Vatva Ahmedabad 382445 (India). | Dissolution & Assay | CDSCO, Ahmedabad | CDL, Kolkata |
33 | Metoprolol Succinate Prolonged-Release Tablets I.P. 25 mg | TGME22006 | 12/2022 | 11/2024 | Ravian Life Science Pvt. Ltd., Plot No. 34, Sector- 8A, IIE, SIDCUL, Haridwar 249 403, Uttarakhand | Dissolution | CDSCO, South Zone | CDL, Kolkata |
34 | Tacrolimus Ointment 0.03% (Tacromed 0.03 Ointment) | HTO203 | 05/2022 | 04/2024 | Med Manor Organics Pvt. Ltd., Unit-II, Kh. No.143M/7, Village- Raipur, Pargana- Bhagwanpur, Tehsil- Roorkee, Dist. Haridwar, Uttarakhand 247 661. | Assay | CDSCO, Hyderabad | CDL, Kolkata |
35 | Amikacin Sulphate Injection I.P. 500 mg | 7900323 | 03/2023 | 02/2025 | Karnataka Antibiotics & Pharmaceuticals Limited (A Govt. of India Enterprise), Plot No. 14, II Phase Peenya Bengaluru- 560058, India. | Description & Particulate Matter | CDSCO, East Zone | CDL, Kolkata |
36 | Levocarnitine Injection U.S.P. (REE) | ELF8BH3004 | 07/2023 | 06/2026 | Emcure Pharmaceuticals Ltd., J-174, J-168 & J- 168/1, MIDC Tarapur, Boisar, Dist. Thane- 401506 | Description & Particulate Matter in Injection | CDSCO, East Zone | CDL, Kolkata |
37 | Levosalbutamol Syrup 1mg / 5ml | 2027 0623 | 06/2023 | 05/2025 | Greenco Biologicals Pvt. Ltd., Krishnapur, P.O. Madanpur, Krishnapur, P.S. Madhyamgram, Distt. North 24 Parganas, Kolkata 700128. | Description & pH | CDSCO, East Zone | CDL, Kolkata |
38 | Glycerin IP 98% w/w | 0453 | 11/2022 | 10/2024 | Saar Biotech Pvt. Ltd., VPO Bhud, Tehsil Baddi, Distt. Solan (H.P.) 173205. | Water & Assay of Glycerin | CDSCO, East Zone | CDL, Kolkata |
39 | Pyrazinamide Tablets IP 500 mg, (Pyrazinamide- 500) | T-5674 | 12/2022 | 11/2024 | Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar 143001 (India). | Description & Dissolution | CDSCO, East Zone | CDL, Kolkata |
40 | Ursodeoxycholic Acid Tablets IP (Mascholic- 300) | MT223471 | 07/2022 | 06/2024 | Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sec- 6A, IIE, Sidcul, Haridwar- 249403, Uttarakhand, India. | Description | CDSCO, East Zone | CDL, Kolkata |
41 | Ambroxol Hydrochloride Solution 100 ml | AML3035 | 07/2023 | 06/2025 | Caplet India Pvt. Ltd., Rekjuani, Kolkata-700135. | Description | CDSCO, East Zone | CDL, Kolkata |
42 | Pheniolic Disinfecting Multipurpose Surface Cleaner cum Deodriser (Lemenol) | Not mentioned | Not mentioned | Not mentioned | Pragati Udyog, Rudhiya Mesra, Ranchi-15 | Classification, Gradation, Germicidal value (RW Coefficient) & Labelling | State FDA, Ranchi-VII, Jharkhand | CDL, Kolkata |
43 | Pheniolic Disinfecting Multipurpose Surface Cleaner cum Deodriser (Lytner) | Not mentioned | Not mentioned | Not mentioned | Pragati Udyog, Rudhiya Mesra, Ranchi-15 | Gradation, Germicidal value (RW Coefficient) & Labelling | State FDA, Ranchi-VII, Jharkhand | CDL, Kolkata |
44 | Pheniolic Disinfecting Multipurpose Surface Cleaner cum Deodriser (Cleaner) | B 20 | Not mentioned | Not mentioned | Pragati Udyog, Rudhiya Mesra, Ranchi-15 | Gradation, Germicidal value (RW Coefficient) & Labelling | State FDA, Ranchi-VII, Jharkhand | CDL, Kolkata |
45 | Disinfecting Multipurpose Surface Cleaner cum Deodriser (Nemonol Premium) | Not mentioned | Not mentioned | Not mentioned | Pragati Udyog, Rudhiya Mesra, Ranchi-15 | Classification, Gradation, Type, Stability after Dilution, Germicidal value (RW Coefficient) & Labelling | State FDA, Ranchi-VII, Jharkhand | CDL, Kolkata |
46 | Phenolyne Disinfectant Fluid Phenolic Type (Phenolyne) | Not mentioned | Not mentioned | Not mentioned | Pragati Udyog, Rudhiya Mesra, Ranchi-15 | Labelling | State FDA, Ranchi, Jharkhand | CDL, Kolkata |
47 | Phenolyne Disinfectant Fluid Phenolic Type (Phenolyne) | A | Not mentioned | Not mentioned | B.R.S. Chemical Works, 39, Harish Chatterjee St. Kolkata- 700026. | Gradation, Germicidal value (RW Coefficient) & Labelling | State FDA, Ranchi, Jharkhand | CDL, Kolkata |
48 | Paracetamol Tablets I.P. 500 Mg. | GT2G030 | Jul-2022 | Jun-2025 | Scott-Edil Pharmacia Ltd., 56, EPIP, Phase-I, Jharmajri, Baddi, Dist. Solan-173205(H.P.) INDIA | Dissolution | State FDA , Assam | RDTL, Guwahati |
49 | GLIMEPIRIDE TABLETS I.P. (2 mg.) | MT224871 | Oct-2022 | Sep-2024 | Mascot Health Series Private. Limited., Plot No. 79, 80, Sector-6A, IIE, SIDCUL, Haridwar- 249403 | Description | State FDA , Assam | RDTL, Guwahati |
50 | AMLODIPINE BESYLATE TABLETS I.P. 5 mg. (AMLOMART-5 mg TABLETS) | PT-31011 | Apr-2023 | Mar-2025 | Pharmaroots Healthcare, Khasra No. 411, Village Tipra, P.O. Barotiwala, Tehsil Baddi, Distt. Solan, H.P. | Assay of Amlodipine | State FDA, Arunachal Pradesh | RDTL, Guwahati |
51 | Etizolam Tablets (0.5 mg) | 2268 | Nov-2022 | Oct-2024 | RELIANCE Formulation Pvt. Ltd., 7/2-A, G.I.D.C. Estate, Phase-I, Vatva, Ahmedabad - 382 445. | content of Etizolam (assay) | CDSCO Sub Zone, Guwahati | RDTL, Guwahati |
52 | PANTOPRAZOLE TABLETS I.P. (40 mg) | PAA-504 | Jan-2023 | Dec-2024 | Healers Lab, Unit-II, Plot No. 33, HPSIDC Extn., Baddi, Dist. -Solan, H.P. | Dissolution in Acid Stage & Description | State FDA, Assam | RDTL, Guwahati |
53 | Methylcobalamin, Pyridoxine Hcl, Nicotinamide & D Panthenol Injection (NEUROSIN PLUS), 2ml. | H30051 | Aug-2023 | Jan-2025 | Arion Healthcare, Vill. Kishanpura, Baddi, Distt. Solan-174101 (H.P.) | Identification and Assay of D- Panthenol | CDSCO SUB- ZONE, BADDI | RDTL, Guwahati |
54 | Ramipril Tablets I.P. 5 mg. | RMFT1001 | Jun-2022 | May-2024 | Unicure India Ltd,, C-21, 22 & 23, Sector-3, Noida- 201 301, Distt. Gautam Budh Nagar (U.P.). | content of Ramipril (Assay) | State FDA, Patna, Bihar | RDTL, Guwahati |
55 | ALBENDAZOLE TABLETS I.P. | MS4AI2301 | Jan-2023 | Dec-2025 | MAXTAR BIO-GENICS, Khasra No. 705, Vill. Malku Majra, Nalagarh Road, Baddi, Distt. Solan- 173205 (H.P.)- India | Dissolution | CDSCO Sub Zone, Guwahati | RDTL, Guwahati |
56 | Ibuprofen and Paracetamol Tablets I.P. (400 mg/325 mg) | GT1153 | Jun-2022 | May-2024 | OMEGA PHARMA, Khasra No.-482, Village- Saliyar, Roorkee-247667, Distt.- Haridwar, (Uttarakhand) | Dissolution of Ibuprofen and Paracetamol | State FDA, Jharkhand | RDTL, Guwahati |
57 | SUCRALFATE & OXETACAINE SUSPENSION 1 gm + 10 mg (RANPURE SUSPENSION) | AL23-0108 | Feb-2023 | Jan-2025 | ASPO PHARMACEUTICALS LLP, Plot No.10, HIMUDA Industrial Area, Phase-IV, Bhatoli Kalan, Baddi, Distt. Solan (H.P.) - 173205 | pH and Assay Content of Oxetacine | CDSCO Zonal Office, Hyderabad | CDTL, Hyderabad. |
58 | SORBITAL 70 % IP | GAIL/IP/509 | Jul-2023 | Jun-2028 | GOYA AGRO INDUSTRIES LIMITED, DML NO-1080-OSP (H) Factory : Vill. Khanpur Kollan Kurukshetra - 136131 | Test for Ethylene Glycol | CDSCO Zonal Office, Baddi | CDTL, Hyderabad. |
59 | SPIRONOLACTONE TABLETS IP 25 mg (ALDACTONE) | 02A22020 | Nov-2022 | Oct-2025 | RPG LIFE SCIENCES LIMITED, 3102/A, G.I.D.C., Estate, Ankleshwar-393 002, Dist. Bharuch, Gujarat, India. | Dissolution | CDSCO Zonal Office, Hyderabad | CDTL, Hyderabad. |
Also Read:Drug alert: CDSCO flags 62 drug samples
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