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