CDSCO Drug Alert: 46 Drug Samples Including Sun Pharma's Levipil 500 Flagged
New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drug Standard Control Organisation (CDSCO) has flagged 46 medicine batches for failing to qualify for a random drug sample test for January– 2024.
These include Moxifloxacin and Prednisolone Acetate Eye Drops (MOXIZEEP Eye Drops) manufactured by Zee Laboratories, Ondansetron Tablets IP 4 mg manufactured by Unicure India, Cefixime Oral Suspension IP 50mg/5ml manufactured by Ridley Life Science, Diclofenac Sodium Injection manufactured by ANG Lifesciences, Metronidazole Tablets IP 400 mg manufactured by Vivek Pharmachem, Trypsin, Bromelain and Rutoside Trihydrate Tablets manufactured by Pure and Cure Healthcare, Amoxycillin and Potassium Clavulanate Tablets IP 375 mg manufactured by Modern Laboratories and others.
Furthermore, the list of drug samples that are declared 'Not Of Standard Quality' includes Levetiracetam Tablets IP (Levipil 500) manufactured by Sun Pharma Laboratories, and Pantosec (Pantoprazole Tablets IP 40mg) manufactured by Hetero Labs.
This came after the analysis and tests conducted by the CDSCO Drugs Control Department on 932 samples. Of these, 886 samples were found to be of standard quality while 46 were declared 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 uniformity of weight, failure of clarity of solution and particulate matter, failure of pH, and description.
The samples collected were tested in four laboratories, RDTL Chandigarh, CDL Kolkata, CDTL Hyderabad, CDTL Mumbai, and RDTL- Guwahati.
List of Drugs, Medical Devices, Vaccine, and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of January– 2024
List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of January– 2024 | ||||||||||
Total no. of samples received | - 846 | |||||||||
Total number of samples tested | - 932 | |||||||||
Total number of samples declared as of Standard Quality | - 886 | |||||||||
Total number of samples declared as Not of Standard Quality | - 46 | |||||||||
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 | Chlorhexidine Gluconate Solution 4% w/v Surgical Scrubbing | JDO-1027 | 05/2023 | 04/2025 | Jpee Drugs, Plot No. - 53, Sector 6-A, SIDCUL, Haridwar (Uttarakhand). | pH, weight per ml and Assay | CDSCO, East Zone, Kolkata | Central Drugs Laboratory, Kolkata | ||
2 | Glimepiride Tablets I.P. 1 mg | GLI10923 | 05/2023 | 04/2025 | Karnataka Antibiotics & Pharmaceuticals Limited Arka The Business Centre, Plot No. 37, Site No. 34/4, NTTF Main Road, Peenya Industrial Area, 2nd Phase, Bengaluru - 560 058, India. | Dissolution Glimepiride | of | CDSCO, East Zone, Kolkata | Central Drugs Laboratory, Kolkata | |
3 | Levosalbutamol, Guaiphenesin & Ambroxol (Duvent- PD) | DPD030 | 01/12/2023 | 30/11/2026 | Hygeia Pharmaceuticals MFG. (P) Ltd. 608, Dwarir Road Dhamaitala Dakshin Jagaddal, Pin- 700151 | Assay/content of Levosalbutamol & Ambroxol Hydrochloride | CDSCO, East Zone, Kolkata | Central Drugs Laboratory, Kolkata | ||
4 | Amoxycillin and Potassium Clavulanate Tablets IP 375 mg | APCT2305 | 02/2023 | 01/2025 | Modern Laboratories, 45- 47, Sector D-2, Industrial Area, Sanwer Road, Indore (M.P.) 452015, India | Assay of Amoxycillin, Clavulanic Acid & Dissolution of Amoxycillin, Clavulanic Acid | CDSCO, East Zone, Kolkata | Central Drugs Laboratory, Kolkata |
5 | Mesalazine Prolonged-release Tablets IP 1200 mg | UGT23128 | 01/2023 | 12/2024 | Unimarck Healthcare Ltd., Plot No. 24, 25 & 37, Sector 6A, SIDCUL, Haridwar- 249403 (Uttarakhand). | Dissolution | CDSCO, East Zone, Kolkata | Central Drugs Laboratory, Kolkata |
6 | Vitamin A Oral Solution 100 ml | JDL-2921 | 06/2023 | 11/2024 | Jpee Drugs, Plot No. - 53, Sector 6-A, SIDCUL, Haridwar (Uttarakhand). | Microbial Enumeration | CDSCO, East Zone, Kolkata | Central Drugs Laboratory, Kolkata |
7 | Levosalbutamol, Ambroxol & Guaiphenesin Syrup (Bromex - LS Expectorant) | BXE064 | 01/12/2023 | 30/11/2026 | Hygeia Pharmaceuticals MFG. (P) Ltd. 608, Dwarir Road Dhamaitala Dakshin Jagaddal, Pin- 700151 | Assay/content of 'Levosalbutamol' | CDSCO, East Zone, Kolkata | Central Drugs Laboratory, Kolkata |
8 | Trypsin, Bromelain & Rutoside Trihydrate Tablets | PF8CC12 | 08/2023 | 07/2025 | Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27-30, Sector- 8A, IIE, SIDCUL, Ranipur, Distt. Haridwar - 249403, Uttarakhand. | Assay of 'Trypsin' | CDSCO, East Zone, Kolkata | Central Drugs Laboratory, Kolkata |
9 | Levetiracetam Tablets IP (Levipil 500) | SIE1003A | 04/2023 | 03/2025 | Sun Pharma Laboratories Ltd., Plot No. 107-108, Namli Block, P.O. Ranipool, Sikkim - 737 135 | Dissolution | CDSCO (North Zone), Ghaziabad | Central Drugs Laboratory, Kolkata |
10 | Livocitra (Levocetirizine Hydrochloride Tablets I.P.) | AHT-23503 | 10/2023 | 09/2025 | Aru Healthcare Pvt. Ltd., K-12, Industrial Area, Begrajpur, Muzaffarnagar - 251 003 | Dissolution | CDSCO (North Zone), Ghaziabad | Central Drugs Laboratory, Kolkata |
11 | Clindamycin Injection I.P. (Clindacin-300) | SAI-16589 | 11/2022 | 10/2024 | Sunvet Healthcare, Village Shambhuwala, Paonta Road, Distt. Sirmour (H.P.) 173001 | Description & Particulate Matter | Drugs Control Administration, Narasaraopet, Andhra Pradesh | Central Drugs Laboratory, Kolkata |
12 | Amikacin Sulphate Injection I.P. (Amicin-100) | SVI-6964 | 11/2022 | 10/2024 | Sunvet Healthcare, Village Shambhuwala, Paonta Road, Distt. Sirmour (H.P.) 173001 | Description & Particulate Matter | Drugs Control Administration, Narasaraopet, Andhra Pradesh | Central Drugs Laboratory, Kolkata |
13 | Fungal Diastase & Pepsin Syrup (NVZYME) | 23RL0230 | 07/2023 | 12/2024 | Regency Healthcare, 4KM Stone Kashipur Road, Danpur Rudrapur, Distt. U.S. Nagar, Uttarakhand | Assay of Fungal Diastase | Drugs Inspector, O/o CMO Bilaspur, Himachal Pradesh | Central Drugs Laboratory, Kolkata |
14 | Cyproheptadine HCl & Tricholine Citrate Syrup (Cypermed Syrup) | AQC2339A | 03/2023 | 02/2025 | Aquinnova Pharmaceuticals Plot No. 85, Ind. Area, Lodhimajra, Baddi, Distt. Solan - 174101 (H.P.) | Assay of Tricholine Citrate | Drugs Inspector, O/o CMO Bilaspur, Himachal Pradesh | Central Drugs Laboratory, Kolkata |
15 | Moxifloxacin & Prednisolone Acetate Eye Drops (MOXIZEE- P Eye Drops) | 1223-51 | 02/2023 | 01/2025 | Zee Laboratories Limited, Behind 47, Industrial Area, Paonta Sahib - 173025. | Assay of Prednisolone Acetate | Drugs Inspector, Paonta Sahib, Himachal Pradesh | Central Drugs Laboratory, Kolkata |
16 | Ceftriaxone Injection I.P. (DOXONE 1000) | JDI-3074 | 01/2023 | 12/2024 | Jpee Drugs, Plot No. - 53, Sector 6-A, SIDCUL, Haridwar (Uttarakhand). | Clarity of Solution, Particulate matter & Sterility | Drugs Inspector, Cuttack, Odisha | Central Drugs Laboratory, Kolkata |
17 | Absorbable Suture (Synthetic) USP Monolus Monofilament Poly (Glycolide-Co- Caprolactone) Poliglecaprone-25 | N190096AF | 05/2019 | 04/2024 | Lotus Surgicals Pvt. Ltd., Khasra No. 1051/1 & 2, Twin Industrial Estate, Selaqui, Dist. Dehradun, Pin 248197 (Uttarakhand), India. | Diameter | CDSCO, South Zone, Chennai | Central Drugs Laboratory, Kolkata |
18 | Surgical Tape (JMS Medi-Tape 300) | 2022006 | 04/2022 | 03/2025 | JMS Co. Ltd., 12-17 Kako-Machi, Naka-Ku, Hiroshima 730-82452, Japan | Length | CDSCO, West Zone, Mumbai | Central Drugs Laboratory, Kolkata |
19 | Surgical Tape (JMS Medi-Tape 310) | 2022003 | 02/2022 | 01/2025 | JMS Co. Ltd., 12-17 Kako-Machi, Naka-Ku, Hiroshima 730-8652, Japan | Length | CDSCO, West Zone, Mumbai | Central Drugs Laboratory, Kolkata |
20 | Surgical Tape (JMS Medi-Tape 320) | 2022004 | 03/2022 | 02/2025 | JMS Co. Ltd., 12-17 Kako-Machi, Naka-Ku, Hiroshima 730-8652, Japan | Length | CDSCO, West Zone, Mumbai | Central Drugs Laboratory, Kolkata |
21 | Surgical Tape (JMS Medi-Tape 330) | 2022004 | 03/2022 | 02/2025 | JMS Co. Ltd., 12-17 Kako-Machi, Naka-Ku, Hiroshima 730-8652, Japan | Length | CDSCO, West Zone, Mumbai | Central Drugs Laboratory, Kolkata |
22 | Bacillus Clausii Spores Suspension (LB LAC Oral Suspension) | AVA23I1 | 05/2023 | 04/2025 | Allianz Biosciences Pvt. Ltd., 55/1, 2 & 3, Whirlpool Road, Thiruvandar Koil, Puducherry - 605102 | Identification, Average Volume, Resistance to antibiotic, Presence of Salmonella species & Assay | Drug & Food Control Organisation, Jammu & Kashmir | Central Drugs Laboratory, Kolkata |
23 | Metformin HCl Prolonged- Release & Glimepiride Tablets IP (Glimycare-M3 Forte) | T-230761 | 07/2023 | 06/2025 | Vilin Bio Med Ltd., Unit-II, Khasra No. 85, Madhopur, Hazarathpur, Roorkee-247667, Uttarakhand. | Assay & Uniformity of Content of Glimepiride | CDSCO, Rishikesh | Central Drugs Laboratory, Kolkata |
24 | Tranexamic Acid & Mefenamic Acid Tablets (Trancycle-MF) | DMT1127 | 01-Aug-2023 | 01-Jul-2025 | DM Pharma Private Limited, Village Bhud, NH-21A, Baddi, District Solan (H.P.) | Assay | CDSCO, Hyderabad | CDTL, Hyderabad |
25 | Ambroxol Hydrochloride I.P. Syrup (AMBROS) | GF296 | Dec-2023 | Nov-2025 | Global Formulations, Plot No.7, P & T Colony, Medipally, Medchal Dist., Hyderabad-500098, T.S | Weight per ml | CDSCO, Hyderabad | CDTL, Hyderabad |
26 | Ambroxol HCl, Levosalbutomol Sulphate Guaiphenesin Syrup (Brotex-LS) | GF.292 | 01-Dec-2023 | 30-Nov- 2025 | Global Formulations, Plot No.7, P & T Colony, Medipally, Medchal- Malkajgiri Dist., - 5000098, | Weight per ml | CDSCO, Hyderabad | CDTL, Hyderabad |
27 | Terbutaline Sulphate, Ambroxol Hydrochloride, Guaiphenesin & Menthol Syrup (Scoril) | GF-279 | Nov-2023 | Oct-2025 | Global Formulations, Plot No.7, P & T Colony, Medipally, Medchal- Malkajgiri Dist., Hyderabad-500098, | Weight per ml & Assay | CDSCO, Hyderabad | CDTL, Hyderabad |
28 | Folic Acid Tablets IP 5 mg | T112005 | May-22 | Apr-24 | ANG LIFESCIENCES INDIA LTD., Village Malkumajra, Nalagarh Road, Distt. Solan- 173205 (H.P.) | Description as the tablets are brittle & shows mottled appearance | CDSCO, West- Zone, Mumbai | CDTL- Mumbai |
29 | Bisacodyl Tablets I.P. 5 mg (Laxagen) | 230754 | Jul-23 | Jun-26 | Modi Antibiotics., Plot No, 28, G.I.D.C. Estate, Odhav, Ahmedabad - 382415, (Guj). | Related Substances | CDSCO, West- Zone, Mumbai | CDTL- Mumbai |
30 | Metronidazole Tablets IP 400 mg | MZTJ23002 | Jun-23 | May-25 | Vivek Pharmachem (India) Ltd., EPIP, Bari Brahmana, Jammu- 181 133 | Description | CDSCO, West- Zone, Mumbai | CDTL- Mumbai |
31 | Pantosec (Pantoprazole Tablets IP 40mg) | PNS230422 | Apr-23 | Mar-25 | Hetero Labs Limited (Unit-I), Kalyanpur (Village), Chakkan Road, Baddi (Tehsil), Solan (Distt.), Himachal Pradesh - 173 205., India | Dissolution in Buffer stage | CDSCO, West- Zone, Mumbai | CDTL- Mumbai |
32 | Terbutaline, Bromhexine, Guaiphenesin and Menthol Syrup (Terbo-Q Syrup) | LKM-38 | Sep-2022 | Aug-2024 | Amkay Laboratories Pvt. Ltd., Preet Vihar, Nauchandi, Meerut. | Assay of Bromhexine Hydrochloride | CDSCO (North Zone), Ghaziabad | RDTL, Chandigarh |
33 | Levocetirizine Tablets IP | LVU-515 | Jun-2023 | May-2025 | Healers Lab, Unit II, Plot No.33, H.P.S.I.D.C., Extn., Baddi, Distt. Solan (HP) | Identification and Assay of Levocetirizine Hydrochloride | CDSCO (North Zone), Ghaziabad | RDTL, Chandigarh |
34 | Glimepiride, Pioglitazone and Metformin (PR) Tablets (GLEM- GMP2 Tablets) | MPT-22149 | Sep-2022 | Aug-2024 | Magnatek Enterprises, Plot No. 74 C (II) HPSIDC Ind. Area Baddi, Distt. Solan (HP) 173205 | Identification and Assay of Pioglitazone Hydrochloride calculated as Pioglitazone | O/o State Drugs Controller, H.Q. Baddi, Distt. Solan, HP- 173205 | RDTL, Chandigarh |
35 | Calcium and Vitamin D3 Tablets I.P | UDT10704 | Mar-2023 | Aug-2024 | Unicure India Ltd., C-21, 22 & 23, Sector-3, Noida- 201301, Distt. Gautam Budh Nagar (U. P.) | Description | Inspector of Drugs, Assam | RDTL, Guwahati |
36 | Pantoprazole Gastro-Resistant Tablets I.P. (P40) | PFT23007MB | May-2023 | Apr-2025 | Sri Ram Healthcare Pvt. Ltd., Plot No. 81-C/2, EPIP Phase - I, Jharmajri, Baddi, Distt. - Solan, (H.P.) - 174 103. | Dissolution | Inspector of Drugs, Assam | RDTL, Guwahati |
37 | Pantoprazole Sodium (EC) & Domperidone (SR) Capsules IP (Panzon-DSR) | BBC22550 | May-2022 | Apr-2024 | Biomax Biotechnics (P) Ltd., 261, HSIIDC, Industrial Estate, Alipur, Barwala134118 (Haryana) | Dissolution of Pantoprazole in acid stage & Description | Inspector of Drugs, Assam | RDTL, Guwahati |
38 | GLIMEPIRIDE TABLETS I.P. 1 mg. | GLT-2301 | Jan-2023 | Dec-2024 | Apple Formulations Pvt. Ltd,, Plot No.208, Kishanpur, Roorkee- 247667 (U.K) | Dissolution | Inspector of Drugs, Assam | RDTL, Guwahati |
39 | COMPOUND SODIUM LACTATE INJECTION I.P. (RL) | 03B3911 | Jun-2023 | May-2026 | PASCHIM BANGA PHARMACEUTICAL, NH-31, TIN MILE HAT, SONAPUR HAT, P.S.- CHOPRA, DIST : UTTAR DINAJPUR, PIN - 733214 (W.B.) | Sterility Particulate Contamination and Description | Inspector of Drugs, Assam | RDTL, Guwahati |
40 | Montelukast Sodium & Levocetirizine Hydrochloride Tablets IP. (Folcet- MT) | FPT-2067 | Oct-2022 | Sep-2024 | Forgo Pharmaceuticals., 27, DIC IND AREA, Barotiwala, Teh: Baddi, Distt. Solan (HP) 174103 | Assay/Content of Montelukast | Inspector of Drugs, Jharkhand | RDTL, Guwahati |
41 | Montelukast Sodium & Levocetirizine Dihydrochloride Tablets IP..(Pevicet M TABLETS) | AT22-0667A | Sep-2022 | Aug-2024 | ASPO PHARMACEUTICALS LLP., Plot No. 10, HIMUDA Industrial Area, Phase-IV, Bhatoli Kalan, Baddi Distt. Solan (H.P.) 173205 | Dissolution (Montelukast & Levocetirizine Dihydrochloride) | Inspector of Drugs, Bihar | RDTL, Guwahati |
42 | Ondansetron Tablets IP 4 mg | SMT1006 | Nov-2022 | Oct-2024 | Unicure India Ltd,, C-21, 22 & 23, Sector-3, Noida- 201 301, Distt. Gautam Budh Nagar (U.P.). | Dissolution | Inspector of Drugs, Bihar | RDTL, Guwahati |
43 | Levocetirizine Dihydrochloride & Montelukast Tablets (Tesact- M Tablets) | RT22464 | Jul-2022 | Jun-2024 | RACHIL PHARMA, 18- 19, Phase-1, Ind. Area, Sansarpur Terrace, Distt : Kangra (H.P.) -176501. | Dissolution (Levocetirizine Dihydrochloride ) | Inspector of Drugs, Jharkhand | RDTL, Guwahati |
44 | Cefixime Oral Suspension IP 50mg/5ml | RD230004 | Jan-2023 | Dec-2024 | Ridley Life Science Pvt. Ltd.,, D-1651, DSIDC, Indl. Complex, Narela, Delhi- 110040 | Assay of Cefixime | Inspector of Drugs, Meghalaya | RDTL, Guwahati |
45 | Cefixime Oral Suspension IP 50mg/5ml | RD230003 | Jan-2023 | Dec-2024 | Ridley Life Science Pvt. Ltd.,, D-1651, DSIDC, Indl. Complex, Narela, Delhi- 110040 | Assay of Cefixime | Inspector of Drugs, Meghalaya | RDTL, Guwahati |
46 | Diclofenac Sodium Injection IP | I213108 | Jul-2023 | Jun-2025 | ANG Lifesciences India Ltd., Village Malkumajra, Nalagarh Road, Baddi, Distt. Solan173205 (H.P.) | Particulate matter and Description | Inspector of Drugs, Assam | RDTL, Guwahati |
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