CDCSO Declares 31 Formulations As Not of Standard Quality: Details
New Delhi: In its latest drug safety alert, the apex drug regulatory body, the Central Drug Standard Control Organisation (CDSCO), has flagged 31 medicine batches for failing to qualify for a random sample test for June 2024.
The list of drugs declared not of standard quality includes Propylene Glycol manufactured by Manali Petrochemicals, Compound Sodium Lactate Injection I.P., 500 ml (Ringer Lactate Solution for Injection) manufactured by Vision Parenteral, Esomeprazole Gastro-Resistant Tablets manufactured by GlenSmith Labs, Gentamicin Sulphate Injection manufactured by Zee Laboratories, Frusemide Injection manufactured by Nandani Medical; Amoxycillin and Potassium Clavulanate Injection IP 1.2 gm, manufactured by Sai Parenterals Limited, Glipizide and Metformin Tablets IP (Glynase-MF) manufactured by USV Private and others.
A few reasons why the drug samples tested failed were the presence of bacterial endotoxins, failure of the dissolution test, failure of the pH, failure of the description and particulate matter, failure of specific assays of the drug test, etc.
NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF JUNE 2024.
|
A. CDSCO/Central Laboratories |
|||||||
|
S.No |
Product/Drug Name |
Batch No. |
Manufacturing Date |
Expiry Date |
Manufactured By |
NSQ Result |
Reported by CDSCO Laboratory |
|
1. |
Propylene Glycol I.P. |
PG- IP/2023- 24/2355 |
11/2023 |
10/2028 |
M/s. Manali Petrochemicals Ltd., Manali, Chennai- 600068, India |
Relative Density |
CDL, Kolkata |
|
2. |
Propylene Glycol USP/IP |
BT1205B0 4072023 |
07/2023 |
07/2024 |
M/s. Balaji Amines Limited, Plot No. F- 104, Chinchoili M.I.D.C., Tq. Mohol, Distt. Solapur – 413 255, Maharastra |
Relative Density |
CDL, Kolkata |
|
3. |
Compound Sodium Lactate Injection I.P., 500 ml (Ringer Lactate Solution for Injection) |
P2401050 08 |
01/2024 |
12/2025 |
M/s. Vision Parenteral Pvt. Ltd., A-2-44, 45, Sector-15, GIDA Industrial Area, Gorakhpur -273209 (U.P.), India |
Bacterial endotoxins |
CDL, Kolkata |
|
4. |
Esomeprazole Gastro- Resistant Tablets IP 40 mg (Esomedge- 40) |
GD23083 |
07/2023 |
06/2025 |
M/s. GlenSmith Labs Private Limited, Mfg. by: Skymap Pharmaceuticals Pvt. Ltd., B-3, Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee 247 667. |
Dissolution |
CDL, Kolkata |
|
5. |
Gentamicin Sulphate Injection I.P. 2 ml |
323-216 |
03/2023 |
02/2025 |
M/s. Zee Laboratories Ltd., Behind 47, Indl. Area, Paonta Sahib – 173025 |
Description & Particulate matter |
CDL, Kolkata |
|
6. |
Frusemide Injection IP 2 ml (FRUSEMIDE) |
FRA12347 |
12/2023 |
11/2025 |
M/s. Nandani Medical Laboratories Pvt. Ltd., 221/5, Bicholi Hapsi, Kanadia Road, Indore |
pH |
CDL, Kolkata |
|
7. |
Ceftriaxone for Injection I.P. 1 gm |
DC30119 |
10/2023 |
09/2025 |
M/s. Captab Biotec Unit-II, Plot No-125, E.P.I.P Road, Mauja Jharmajri, Baddi, Distt.-Solan H.P. |
Particulate matter |
CDL, Kolkata |
|
8. |
Amoxycillin & Potassium Clavulanate Injection IP 1.2 gm |
23AP04 |
05/2023 |
04/2025 |
M/s. Sai Parenterals Limited, D1 & D4, Survey No. 280, Phase- V, IDA, Jeedimetla, Hyderabad-500 055, TS. |
Clarity of Solution and Assay of Potassium Clavulanate |
CDL, Kolkata |
|
9. |
Cefixime & Ofloxacin Tablets (CEFIKAM OF 200) |
DB230057 |
02/2023 |
01/2025 |
M/s. Daxin Pharmaceuticals Pvt. Ltd., Plot No-121-122, EPIP, Jharmajri Phase-1, Teh. Baddi, Distt. Solan (H.P.) 174 103. |
Assay of Cefixime Trihydrate & Assay Ofloxacin |
CDL, Kolkata |
|
10. |
Propylene Glycol USP |
97220141 13 |
11/2023 |
10/2028 |
M/s. Shell Eastern Chemicals, The Metropolis Tower, 1, 9 North Buona, Visla |
Specific Gravity |
CDL, Kolkata |
|
Drive 07 01 Singapore 138588 |
|||||||
|
11. |
Ranitidine Hydrochloride Tablets (Ranylaj-150) |
GTDE3019 |
05/2023 |
04/2025 |
M/s. Francis Remdies (India) Pvt.Ltd., Vill- Mandawali, Roorkee, Distt. Haridwar (U.K.) 247670 |
Description |
CDL, Kolkata |
|
12. |
Glipizide and Metformin Tablets IP (Glynase-MF) |
04010026 |
11/2023 |
04/2025 |
M/s. USV Private Limited, At: B-249/B- 250, II Stage, Peenya Industrial Estate, Bangalore-560058 |
Dissolution of Glipizide |
CDL, Kolkata |
|
13. |
Exo Cheri (Dextromethorp han Hydrobromide Chlorpheniramin e Maleate Pheylephrine Hydrochloride Cough Syrup) |
L/040618 |
04/2024 |
01/2026 |
Exotic Pharma, 91/1, G.I.D.C., GODHRA Dist.- Panchmahal, Gujarat- 389001 |
pH |
CDTL-Mumbai |
|
14. |
Etamsylat Tablets 500 mg |
ELT1104 |
02/2024 |
07/2024 |
Unicure India Ltd., C- 21, 22 & 23, Sector-3, Noida-201 301, Distt. Gautam Budh Nagar (U.P) |
Description |
CDTL-Mumbai |
|
15. |
Tranexamic Acid Tablets I.P. 500 mg |
GT31022 |
01/2024 |
12/2025 |
OMEGA PHARMA KhasraNo.-482, Village-Saliyar, Roorkee-247667, Distt.-Haridwar (Uttarakhand) |
Related substances |
CDTL-Mumbai |
|
16. |
Extuss-D (Dextromethorp han HBR, Chlorpheniramin e Maleate & Phenylephrine HCL Syrup) |
2402168 |
02/2024 |
01/2026 |
Brij Healthcare Pvt. Ltd., 51/10, G.I.D.C Estate, Motipura, Himatnagar, Gujarat 383001 |
Assay of Phenylephrin e Hydrochloride |
CDTL-Mumbai |
|
17. |
IRON & FOLIC ACID SYRUP IP |
RIFS-209 |
04/2024 |
09/2026 |
M/s. Revat Laboratories Pvt. Ltd., Works at : 12-321, Opp. I.D.A, Kurnool Road, Pernamitta, Ongole-523002 |
pH and Assay of Folic Acid |
CDTL, Hyderabad |
|
18. |
Prednisolone Tablets IP 10 mg |
PRDT- 1007 |
11/2024 |
10/2024 |
WINGS BIOTECH LLP, 43 & 44, HPSIDC, Industrial Area, Baddi-173205 (H.P.) |
Assay of Prednisolone |
RDTL Chandigarh |
|
19. |
Aloevera, Glycerin and Vitamin-E Soap (D-Soft Soap) |
COS-130 |
03/2024 |
02/2026 |
Samanyu Skin Care, Plot No. 191, HPSIDC, Baddi, Distt. Solan (H.P.)-1732025 |
Matter insoluble in alochol |
RDTL Chandigarh |
|
20. |
Aloevera, Glycerin, Vitamin-E and Jojoba oil (Synmoist Soap) |
COS-132 |
03/2024 |
02/2026 |
Samanyu Skin Care, Plot No. 191, HPSIDC, Baddi, Distt. Solan (H.P.)-1732025 |
Matter insoluble in alochol |
RDTL Chandigarh |
|
21. |
Aloevera+Glyce rin+Almond Oil and Vitamin-E |
COS-131 |
03/2024 |
02/2026 |
Samanyu Skin Care, Plot No. 191, HPSIDC, Baddi, Distt. Solan (H.P.)-1732025 |
Matter insoluble in alochol |
RDTL Chandigarh |
|
Soap (Aqualux Soap) |
|||||||
|
22. |
Fexofenadine Hydrochloride Tablets IP (MANOFEX-180 TABLETS) |
CT232407 15A |
08/2023 |
07/2025 |
CMG BIOTECH PVT. LTD., (Unit-II) Plot No. 58, Phase III, Industrial Area, Sansarpur Terrac HP-176501 |
Dissolution (In 10 minutes) and (in 30 minutes) |
RDTL Chandigarh |
|
23. |
Norfloxacin Oral Suspension (Ridnor Suspension) |
RL230022 |
03/2023 |
02/2025 |
RIDLEY LIFE SCIENCE PVT. LTD., Unit II : D-1566 DSIDC, Ind. Complex, Narela, Delhi-110040 |
Description and Total Fungal Count |
RDTL Chandigarh |
|
24. |
Albendazole Tablets IP |
MS1AO22 01 |
07/2022 |
06/2025 |
MAXTAR BIO- GENICS, Khasra No. 705, Vill. Malku Majra, Nalagarh Road, Baddi, Distt.Solan-173205 (H.P.)-India |
Dissolution |
RDTL Chandigarh |
|
25. |
Pantoprazole Gastro- Resistant Tablets IP 40 mg. |
PGR-07 |
01/2024 |
12/2025 |
Agron Remedies Pvt. Ltd., Sarverkhera, Moradabad Road, Kashipur-244713 (Uttarakhand) |
Dissolution |
RDTL, Guwahati |
|
26. |
Co-trimoxazole Tablets IP (S- tron Tablets SS) |
ST-223 |
06/2023 |
05/2025 |
High Tech Pharma, 49, Khandelwal compound, Palda, Indore (MP) |
Dissolution (Trimethopri m and Sulphametho xazole) |
RDTL, Guwahati |
|
27. |
Montelukast Sodium and Levocetirizine Hydrochloride |
ST23- 384D |
05/2023 |
04/2025 |
M/s Symbiosis Pharmaceuticals Pvt. Ltd.,, Suketi Road, Kala Amb Distt. |
Dissolution of Montelukast Levocetirizine hydrochloride |
RDTL, Guwahati |
|
Tablets IP (Levmont) |
Sirmour, Himachal Pradesh – 173030 |
||||||
|
28. |
Levocetirizine Dihydrochloride and Montelukast Sodium Tablets IP |
23112701 |
03/2023 |
02/2025 |
MERCURY LABORATORIES LIMITED., Unit No.2, Halol Baroda Road, Village: Jarod. Tal: Waghodia, Dist: Vadodara- 391510 |
Dissolution of Montelukast |
RDTL, Guwahati |
|
29. |
Iron and Folic Acid Syrup IP |
IFIS23015 |
08/2023 |
01/2025 |
Galpha Laboratories Limited, Village- Thana, Baddi, Himachal Pradesh- 173205 |
Assay of Folic Acid |
RDTL, Guwahati |
|
30. |
Etoricoxib Tablets I.P. 90 mg. |
ECX-2304 |
08/2023 |
07/2025 |
Apple Formulations Private Limited, Plot No. 208, Kishanpur, Roorkee – 247667 (U.K.) |
Dissolution |
RDTL, Guwahati |
|
31. |
Mannitol Injection I.P. (20% w/v) |
M1M30038 |
07/2023 |
06/2025 |
Kunal Remedies Pvt. Ltd., Khasra 284, Vill. Anaura Kala Faizabad Road, Lucknow 226028, (UP), India |
Test for Sterility |
RDTL, Guwahati |
To view the official notice, click the link below:
