Drug Alert: CDSCO Flags 57 Formulations As Not Of Standard Quality
New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 57 medicine batches for failing to qualify for a random drug sample test for July 2024.
The list of drugs declared not of standard quality includes Ivermectin Tablets manufactured by Duncan Healthcare, Itraconazole manufactured by Bonsai Pharma, Amoxycillin and Potassium Clavulanate Tablets IP (Pressclav625) manufactured by Aurobindo Pharma, Pantoprazole Tablets manufactured by Bonsai Pharma, Propylene Glycol manufactured by Manali Petrochemicals, and others.
Budesonide Nebuliser Suspension BP (Budecort Respules) and Tamsulosin, Dutasteride Tablets (Urimax-D) manufactured by Cipla are also on the 'Not of Standard Quality' list.
Several factors contributed to the drug samples' failure in the test, such as non-compliance with the IP requirements for the particular drug, failure of the dissolution test, pH, and some assays of the drug test, among others.
The samples collected were tested in five laboratories, namely CDL Kolkata, CDTL Mumbai, CDTL Hyderabad , RDTL Guwahati and RDTL Chandigarh.
NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF JULY – 2024.
A. CDSCO/Central Laboratories | |||||||
S.No | Product/Drug Name | Batch No. | Manufactu ring Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
1. | Ivermectin Tablets I.P. 6 mg | JDJS403 | 04/2024 | 03/2026 | M/s. J. DUNCAN HEALTH CARE PVT.LTD., Plot No. 65, 66, 67, Phase-II, Atgaon, Industrial Complex, Atgaon, Tal- Shahapur, Dist-Thane- 421601, Maharashtra State, India. | Dissolution | Central Drugs Laboratory, Kolkata |
2. | Itraconazole 100mg Capsules (FUNGOBEE Capsules) | MAR-24154 | 03/2024 | 02/2026 | M/s. Bonsai Pharma, Kishanpura, Baddi- Nalagarh Road, P.O. Gurumajra, Distt-Solan (H.P.). | Dissolution | Central Drugs Laboratory, Kolkata |
3. | Compound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection) (Hi- Ring-RL) | F31823 | 10/2023 | 09/2026 | M/s. Higgs Healthcare, Khasra No. 480/1, Bhatolikalan, Baddi, H.P. | Assay of Potassium | Central Drugs Laboratory, Kolkata |
4. | Pantoprazole Tablets 40 mg I.P. (MEDIPANTO- | FEB24144 | 02/2024 | 01/2026 | M/s. Bonsai Pharma, Kishanpura, Baddi- Nalagarh Road, P.O. Gurumajra, Distt-Solan | Dissolution | Central Drugs Laboratory, Kolkata |
40 Tablets) | (H.P.). | ||||||
5. | Propylene Glycol IP | PG-IP/2023- 24/2435 | 01/2024 | 12/2028 | M/s. Manali Petrochemicals Limited, Plant II Sathangadu Village, Manali, Chennai- 600068 | Relative Density and Water | Central Drugs Laboratory, Kolkata |
6. | Itraconazole Capsules BP 100 mg | UC-23240A | 10/2023 | 09/2025 | M/s. Ultra Drugs Pvt. Ltd., (Unit-II) H S No. 211, K. No. 77/1, 78/1, Vill. Katha, Baddi, Distt. Solan, (H.P.) 173205. | Dissolution | Central Drugs Laboratory, Kolkata |
7. | Sterile Noradrenaline Concentrate I.P. | KP247236 | 07/2023 | 06/2025 | M/s. NEON LABORATORIES LTD., At: Shatisthal, Plot No. 1-5, At & Post: Shirgaon, Tal. Palghar, Dist. Thane - 401 407, M.S. | Description & Particulate Matter | Central Drugs Laboratory, Kolkata |
8. | Paracetamol Tablets IP 650 mg | 2600823 | 02/2023 | 01/2026 | M/s. Karnataka Antibiotics and Pharmaceuticals Ltd., Plot No. 14, II Phase, Peenya, Bengaluru- 560058 | Description | Central Drugs Laboratory, Kolkata |
9. | Ofloxacin and Ornidazole Tablets I.P. | 6001723 | 06/2023 | 05/2026 | M/s. Karnataka Antibiotics and Pharmaceuticals Ltd., Plot No. 14, II Phase, Peenya Industrial Area, Bengaluru- 560058 | Description | Central Drugs Laboratory, Kolkata |
10. | Carbamazepin e Extended- | TCRN-004 | 10/2023 | 09/2025 | M/s. J.P. Industries, Bhud, Baddi, Dist- | Dissolution | Central Drugs Laboratory, Kolkata |
Release Tablets IP 200 mg | Solan, HP, India. | ||||||
11. | Teneligliptin & Metformin Hydrochloride Extended Release Tablets IP (20 mg / 500 mg) | ST23-2897 | 10/2023 | 09/2025 | M/s. Salud Care (I) Pvt. Ltd., 435, Kishanpur, Roorkee- 247661 | Description & Assay of Teneligliptin Hydrobromid e Hydrate | Central Drugs Laboratory, Kolkata |
12. | Calcium Aspartate, Calcium Orotate, Calcitriol, Minerals and Vitamins Tablets (Ezorb Forte Tablets) | EZF-1873 | 01/2024 | 06/2026 | M/s. Overseas Health Care Pvt. Ltd., 335 Km. Milestone, National Highway No. 1, P.O. Box No. 25, Phillaur-144 410 (Pb). | Assay of Clacitriol | Central Drugs Laboratory, Kolkata |
13. | Budesonide Nebuliser Suspension BP (Budecort Respules) | SN30395 | 04/2023 | 03/2025 | M/s. Cipla Ltd. (Unit-II), Taza Block, Rorathang, Sikkim 737133, India. | Assay of Budesonide | Central Drugs Laboratory, Kolkata |
14. | Propylene Glycol IP | PG-IP/2023- 24/2339 | 11/2023 | 10/2028 | M/s. Manali Petrochemicals Limited, Plant II Sathangadu Village, Manali, Chennai- 600068 | Relative Density | Central Drugs Laboratory, Kolkata |
15. | Ceftriaxone Sodium for Injection IP 1gm / 10 ml | S24015 | 02/2024 | 01/2026 | M/s. Sai Parenterals Limited, Plot No.: 45A & B, Anrich Industrial Estate, IDA Bollaram, | Clarity of solution, Particulate Matter & | Central Drugs Laboratory, Kolkata |
Sangareddy (Dist)- 502325, Telangana | Appearance of solution | ||||||
16. | Calcium Carbonate, Calcitriol, Methylcobalam in, Folic Acid & Vitamin B6 Soft Gelatin Capsules (CAMED-CM) | DBIS-8889B | 01/2024 | 12/2025 | M/s. Broad Injectables Plot No. 51-52, Ind. Area, Tahliwal, Distt. Una-174301 (H.P.) | Disintegration & Assay of Calcitriol, Vitamin B6 & Methylcobala min | Central Drugs Laboratory, Kolkata |
17. | Monopropylen e Glycol USP | 9815216014 | 01/2024 | 01/2026 | M/s. Shell Eastern Chemicals (S) Seraya Manufacturing Site, Singapore | Specific Gravity | Central Drugs Laboratory, Kolkata |
18. | Monopropylen e Glycol USP | 9815617014 | 01/2024 | 01/2026 | M/s. Shell Eastern Chemicals (S) Seraya Manufacturing Site, Singapore | Water & Specific Gravity | Central Drugs Laboratory, Kolkata |
19. | Monopropylen e Glycol USP | 9814815014 | 01/2024 | 01/2026 | M/s. Shell Eastern Chemicals , Metropolis Tower, 1, 9 North Buona Vista Drive 07 01, Singapore-138588 | Water | Central Drugs Laboratory, Kolkata |
20. | Monopropylen e Glycol USP | 9729323113 | 11/2023 | 11/2025 | M/s. Shell Eastern Chemicals (S) Seraya Manufacturing Site, Singapore | Water & Specific Gravity | Central Drugs Laboratory, Kolkata |
21. | Sterile Noradrenaline Concentrate IP (ADRAID) | DP4095 | 03/2024 | 02/2026 | M/s. Divine Laboratories Pvt. Ltd., Block No. 471, Dabhasa, Tal. Padra, Dist. Vadodara- 391440, India | Description & Particulate Matter | Central Drugs Laboratory, Kolkata |
22. | Compound Sodium Lactate Injection I.P. (Ringers Lactate I.P.) RL | 03BF2450 | 03/2024 | 02/2027 | M/s. Paschim Banga Pharmaceuticals (A Unit of Farista Vanijya Pvt. Ltd), NH-31, Tin Mile Hat, Sonapur Hat, P.S. Chopra, Dist. Uttar Dinajpur-733214 (W.B.). | Sterility | Central Drugs Laboratory, Kolkata |
23. | Oxalobacter, Lactobacillus & Bifidobacteriu m with FOS Capsules (OXASPUR) | RHCE23001 | 05/2023 | 10/2024 | M/s. Swift Life Sciences Pvt. Ltd., D- 1, Sara Industrial Estate, Rampur, Dehradun (UK) 248197 | Assay of Oxalobacter Species & Bifidobacteriu m Bifidum | Central Drugs Laboratory, Kolkata |
24. | Tamsulosin and Dutasteride Tablets (Urimax-D) | GH30334 | 05/2023 | 04/2025 | M/s. Cipla Ltd., Verna Indl. State, Goa- 403722 | Identification and Assay of Tamsulosin Hydrochloride , Dutasteride and Description. | Central Drugs Laboratory, Kolkata |
25. | Azithromycin Tablets IP 500 mg (Aziley-500 Tablets) | NZYMT-223 | 09/2023 | 08/2025 | M/s. M Sea Pharmaceuticals (P) Ltd., Surajpur, Paonta Sahib, Sirmour, Himachal Pradesh - 173001. | Dissolution | Central Drugs Laboratory, Kolkata |
26. | Azithromycin Tablets IP 500 mg (ZIK 500 Tablets) | NZKT-013 | 08/2023 | 07/2025 | M/s. M Sea Pharmaceuticals (P) Ltd., Surajpur, Paonta Sahib, Sirmour, Himachal Pradesh - 173025. | Dissolution | Central Drugs Laboratory, Kolkata |
27. | Compound Sodium Lactate Injection I.P. (RL FFS 500 ML) | 03BF1734 | 08/2022 | 07/2025 | M/s. Paschim Banga Pharmaceuticals (A Unit of Farista Vanijya Pvt. Ltd), NH-31, Tin Mile Hat, Sonapur Hat, P.S. Chopra, Dist. Uttar Dinajpur-733214 (W.B.). | Bacterial endotoxins | Central Drugs Laboratory, Kolkata |
28. | Calcium Gluconate Injection I.P. 10 ml | CLG-4148 | 12/2022 | 11/2024 | M/s. Priya Pharmaceuticals, 109/397, Nehru Nagar, Kanpur-12 | Assay of Calcium | Central Drugs Laboratory, Kolkata |
29. | Ceflxime Tablets IP (Zimspor-200) | MBT-03023 | 05/2023 | 04/2025 | M/s. Mestra Pharma Pvt. Ltd., AT: 44-45, Shiv Ganga Industrial Estate, Lakeshwari, Bhagwanpur Roorkee, Haridwar (UK) | Water & Uniformity of Dispersion | Central Drugs Laboratory, Kolkata |
30. | Dextrose and Ascorbic Acid with Zinc Powder (Vz- Plus) | VZ224015 | 04/2024 | 03/2026 | M/s. Styrun Healthcare, Survey No.89, Pirana Road, At & Post: ODD, Ta, Daskroi, Ahmedabad- 382425, Gujrat, India. | Water | Central Drugs Laboratory, Kolkata |
31. | Ciprofloxacin Tablets I.P. 500 mg (Ocif- 500 Tablets) | OCF5-23-222 | 07/2023 | 06/2025 | M/s. Ornate Labs Pvt. Ltd., Bela Industrial Estate, Muzaffarpur - 842 005. | Dissolution | Central Drugs Laboratory, Kolkata |
32. | Ofloxacin & Ornidazole Tablets IP (Samri-OZ) | UGT23J14A | 01/2023 | 12/2024 | M/s. Unigrow Pharmaceuticals, Vill. Katha, Baddi, Distt. Solan, HP | Dissolution & Assay | Central Drugs Laboratory, Kolkata |
33. | Synetivit Capsules (Omega-3 | LSG-2890 | 07/2023 | 12/2024 | M/s. Lifevision Healthcare, Plot No. 140-141, EPIP, Phase- | Disintegration , Assay of Lactic Acid | Central Drugs Laboratory, Kolkata |
Fatty Acid, Green Tea Extract, Ginkgo Biloba, Ginseng, Grape Seeds Extract, Vitamins, Minerals & Trace Elements Soft Gelatin Capsules) | 1, Jharmajri, Baddi, Distt. Solan (H.P.) 174103 | Bacillus, Vitamin B6, Folic Acid & Niacinamide | |||||
34. | Lingocaine & Adrenaline Injection IP (Lignocop- ADR) | 305 | 12/2023 | 11/2025 | Carewin Pharmaceuticals (Guj) Pvt. Ltd., 38, Saket Ind. Estate-II Sarkhej- Bavla NH-8A, PO. Moraiya, Ahmedabad, (Guj.) Pin-382210 | Assay of Adrenaline | CDTL-Mumbai |
35. | Acetylsalicylic Acid 75mg (Kardiorin AK) | JTN23-211 | 07/2023 | 06/2026 | AK Krishna Pharma Ltd. Ltd., Plot No. 68, 69 & 82, 83 Sector-6A, SIDCUL, IIE, Dist. Haridwar, Uttarakhand, india. | Test for Salicylic acid, Assay of Aspirin and Description | CDTL-Mumbai |
36. | Levetiracetam Tablets IP (Levodil-500) | GAG0628 | 08/2023 | 07/2025 | Agron Remedies Pvt. Ltd., Sarverkhera, Moradabad Road, Kashipur-244713, Uttarakhand | Dissolution | CDTL-Mumbai |
37. | Diclofenac Tablets IP 50mg (Snedic- 50) | T24B008 | 02/2024 | 01/2027 | Snehal Pharma & Surgicals Pvt. Ltd., B1/11, MIDC Butibori, Nagpur-441108 | Misbranded (Improper labeling) | CDTL-Mumbai |
38. | Amoxycillin and Potassium Clavulanate Tablets IP (Pressclav- 625) | CT5023001A | 09/2023 | 08/2025 | Aurobindo Pharma Limited, Unit XII, Survey No. 314, Bachupally, Bachupally Mandal, Medchal-Malkajgiri District. Telangana State, india - 500090. | Description | CDTL-Mumbai |
39. | ONDANSETR ON ORALLY DISINTEGRAT ING TABLETS IP 4mg | T-15842 | 12/2023 | 11/2025 | M/s. KARNANI PHARMACEUTICALS PVT. LTD. Fact : 38, Pharma City, Selaqui, Dehradun- 248011 (Uttarakhand) | Description and Uniformity of Content | CDTL, Hyderabad |
40. | ONDANSETR ON ORALLY DISINTEGRAT ING TABLETS IP 4mg | T-15961 | 01/2024 | 12/2025 | M/s. KARNANI PHARMACEUTICALS PVT. LTD. Fact : 38, Pharma City, Selaqui, Dehradun- 248011 (Uttarakhand) | Description and Uniformity of Content | CDTL, Hyderabad |
41. | Calcium 500 mg with Vitamin D3 250 IU Tablets IP | LMT240376 | 03/2024 | 02/2026 | Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector- 6A, IIE, SIDCUL, Haridwar 249403 (U.K) | Dissolution of Calcium & Assay of Vitamin D3 | RDTL, Guwahati |
42. | Albendazole Tablets IP 400 mg (Zento 400) | VGT230119 | 05/2023 | 04/2026 | VAPI CARE PHARMA PVT. LTD., PLOT NO.225/3, NEAR MORARJI CIRCLE, GIDC VAPI, DIST.VALSAD-396195 GUJARAT | Dissolution of Albendazole | RDTL, Guwahati |
43. | COMPOUND SODIUM LACTATE | 03BF2462 | 03/2024 | 02/2027 | PASCHIM BANGA PHARMACEUTICAL, NH-31, TIN MILE HAT, | Sterility | RDTL, Guwahati |
INJECTION I.P. (RL) | SONAPUR HAT, P.S.- CHOPRA, DIST : UTTAR DINAJPUR, PIN - 733214 (W.B.) | ||||||
44. | Calcium 500 mg. with Vitamin D3 250 IU Tablets IP | LMT240412 | 04/2024 | 03/2026 | Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector- 6A, IIE, SIDCUL, Haridwar249403 (U.K) | Dissolution (Calcium) and Assay of Vitamin D3 | RDTL, Guwahati |
45. | Paracetamol Tablets IP 500 mg (Pararex- 500 | CT-5063 | 12/2022 | 11/2025 | CHEMETAC PHARMACEUTICALS 42, MAINA PUR, MEERUT ROAD, GHAZIABAD-201003 | "Dissolution" of Paracetamol. | RDTL, Guwahati |
46. | Pantoprazole Tablets IP | MT-23K36 | 11/2023 | 04/2025 | MARTIN & BROWN BIO-SCIENCES PVT. LTD., K.NO. 918/419, MALKUMAJRA, NALAGARH ROAD, BADDI, DIST.SOLAN (H.P.)-173205 | Dissolution at Buffer Stage | RDTL, Guwahati |
47. | Calcium 500 mg with Vitamin D3 250 IU Tablets IP | LMT240335 | 03/2024 | 02/2026 | Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector- 6A, IIE, SIDCUL, Haridwar-249403 (U.K) | Dissolution (Calcium) and Assay of Vitamin D3 | RDTL, Guwahati |
48. | Calcium 500 mg and Vitamin D3 250 IU Tablets IP | LMT240348 | 03/2024 | 02/2026 | Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector- 6A, IIE, SIDCUL, Haridwar-249403 (U.K) | Dissolution of Calcium and Assay of vitamin D3 | RDTL, Guwahati |
49. | Amoxycillin & Potassium Claulanate Tablets I.P. | MICTAB- 1602 | 03/2024 | 08/2025 | Micro Formulations,, Chambaghat, Near Railway Crossing, Solan, Distt. Solan | Dissolution of Clavulanic Acid and also Assay of | RDTL, Guwahati |
(Zalmoxi-CV 625) | (H.P.) 173211 | Clavulanic Acid | |||||
50. | RABEPRAZOL E TABLETS IP | MT-24B23 | 02/2024 | 07/2025 | MARTIN & BROWN BIO-SCIENCES PVT. LTD., K.NO. 918/419, MALKUMAJRA, NALAGARH ROAD, BADDI, DIST.SOLAN (H.P.)-173205 | Assay | RDTL, Guwahati |
51. | Tranexamic Acid Injection IP (Stopmust Injection) | KEI-110C | 11/2023 | 10/2025 | Elvia Care Pvt. Ltd., Vill Gullarwala, Near Sai Road, Baddi, Distt. Solan (H.P.) | Bacterial Endotoxins Test | RDTL, Guwahati |
52. | RABEPRAZOL E TABLETS IP | MT-24B26 | 02/2024 | 07/2025 | MARTIN & BROWN BIO-SCIENCES PVT. LTD., K.NO. 918/419, MALKUMAJRA, NALAGARH ROAD, BADDI, DIST.SOLAN (H.P.)-173205 | Assay/Conte nt of Rabeprazole Sodium | RDTL, Guwahati |
53. | Pantoprazole Gastro- Resistant Tablets IP 40 mg | PGR-02 | 12/2023 | 11/2025 | Agron Remedies Pvt. Ltd., Sarverkhera, Moradabad Road, Kashipur-244713 (Uttarakhand) | Dissolution in Acid Stage for Pantoprazole | RDTL, Guwahati |
54. | Carboplatin USP | CN24010001 | 01-Jan-2024 | 31-Dec- 2028 | M/s Hetero Labs Limited (Unit-I), Survey No.10, I.D.A., Gaddalotharam, Village: Jinnaram Mandal, Sangareddy Distt. Telangana, India | Identification by IR, by HPLC and Loss on drying | RDTL,Chandighardh |
55. | Pantoprazole for Injection BP (Glanpan | PNDA4C22A | Mar-2024 | Feb-2026 | Aarge Healthcraft, 12A/1, Sector-2, Indl. Area, Parwanoo- | Particulate matter | RDTL ,Chandighardh |
IV Injection) | 173220 (H.P.) | ||||||
56. | Bromhexine Hydrochloride, Terbutaline Sulphate and Guaiphenesin Syrup (T-KUF Expectorant COUGH SYRUP) | UF2184145C | Feb-2024 | Jan-2026 | Ultra Drugs Formulations Pvt. Ltd., Plot No. 338/278, Vill. Manakpur, Lodhimajra, Tehsil-Baddi, Distt. Solan, (H.P.) 173205 | Assay of Terbutaline Sulphate | RDTL ,Chandighardh |
57. | Compound Sodium Lactate Injection IP (Ringers Lactate Solution for Injection) | 2918 | Dec-2022 | Nov-2025 | M/s. HINDUSTAN ANTIBIOTICS LTD., Pimpri,Pune-411018, INDIA | Bacterial Endotoxins | RDTL ,Chandighardh |
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