Drug alert: CDSCO flags 60 formulations as not of standard quality

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-05-22 11:35 GMT   |   Update On 2025-05-22 11:35 GMT

New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has flagged sixty drug batches for failing to qualify for a random drug sample test for April 2025.

The medicines include Ciprofloxacin Tablets IP 250 mg (Ciprodac 250) manufactured by Cadila Pharma, Oxcarbazepine Tablets IP 300 mg (OXCARBAJAJ 300) manufactured by Bajaj Healthcare and Bupivacaine Hydrochloride Injection IP (Bupicain-0.5%) manufactured by Themis Medicare Limited.

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The samples were collected and tested in five laboratories, namely CDL, Kolkata, RDTL, Guwahati, CDTL-Mumbai, RDTL,Chandigarh and CDTL, Indore.

As part of the continuous regulatory surveillance, drug samples are picked from sales/distribution point, analyzed and list of Not of Standard Quality (NSQ) drugs are displayed on CDSCO portal on monthly basis. The purpose of displaying the NSQ list is to make stakeholders aware about the NSQ batches identified in the market.

NOT OF STANDARD QUALITY (NSQ) ALERT FOR THE MONTH OF APRIL-2025- (CDSCO/Central Laboratories)

S.No

Product/Drug Name

Batch No.

Manufacturing Date

Expiry Date

Manufactured By

NSQ Result

Reported by CDSCO

Laboratory

1.

Carboxymethyl Cellulose Sodium Eye Drops IP

MO24H27

08/2024

07/2026

M/s. Martin & Brown Bio- sciences Pvt. Ltd. K.no. 918/419 Malkumajra Nalagarh Road Baddi, Dist. Solan

(H.P.)-173205

pH, Sterility and Assay

CDL, Kolkata

2.

Carboxymethyl Cellulose Sodium Eye Drops IP

MO24H21

08/2024

07/2026

M/s. Martin & Brown Bio- sciences Pvt. Ltd. K.no. 918/419 Malkumajra Nalagarh Road Baddi, Dist. Solan

(H.P.)-173205

pH, Sterility and Assay

CDL, Kolkata

3.

Carboxymethyl Cellulose Sodium Eye Drops IP

MO24H22

08/2024

07/2026

M/s. Martin & Brown Bio- sciences Pvt. Ltd. K.no. 918/419 Malkumajra Nalagarh

Road Baddi, Dist. Solan (H.P.)-173205

pH, Sterility and Assay

CDL, Kolkata

4.

Bupivacaine Hydrochloride Injection IP (Bupicain-0.5%)

BPC24007

12/2024

10/2026

M/s. Themis Medicare Limited, Sector 6A, Plot No.16,17,&18, IIE, SIDCUL Haridwar - 249403, Uttarakhand

Particulate matter and Description

CDL, Kolkata

5.

Ceftriaxone and Sulbactam for Injection IP (CEFRITZ S 1.5)

24DH13V

08/2024

07/2026

M/s. MMG Healthcare, Trilokpur Road, Kala Amb, Distt. Sirmour- 173030 (H.P.)

Bacterial endotoxins for Sterile water for

Injection.

CDL, Kolkata

6.

Pantoprazole Gastro- Resistant Tablets IP 40 mg.

MT240578

08/2024

07/2026

M/s. Mancare Laboratories Pvt. Ltd., Plot No-11,

Pharmacity, Selaqui, Dehradun, Uttarkhand-248011

Dissolution in Buffer Stage

CDL, Kolkata

7.

Oxcarbazepine Tablets IP 300 mg

(OXCARBAJAJ 300)

OXB02I24

09/2024

08/2026

M/s. Bajaj Healthcare Ltd. R.S. No. 1818, Manjusar-Savli Road, At & Post Manjusar, Tal Savli, Dist. Vadodara-391775,

Gujarat, India

Dissolution

CDL, Kolkata

8.

Calcium & Vitamin D3 Tablets IP

QT23136

11/2024

10/2026

M/s. Quest Laboratories Limited, Plot No.-45, Sector-III, Pithampur, Dist-Dhar-454775

(M. P.)

Dissolution (for Calcium) and Assay of Elemental Calcium

CDL, Kolkata

9.

Calcium Carbonate 500 mg + VIT. D3 250 IU

Tablets IP (CALXIA 500

)

GTL1289

12/2024

11/2026

M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC,

Kharedi, Dahod 389151, Gujarat.

Dissolution (for Calcium)

CDL, Kolkata

10.

Calcium Carbonate 500 mg +VIT. D3 250 IU

Tablets IP (CALXIA 500

)

GTL1292

12/2024

11/2026

M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC,

Kharedi, Dahod 389151, Gujarat.

Dissolution (for Calcium)

CDL, Kolkata

11.

Calcium Carbonate 500 mg +VIT. D3 250 IU

Tablets IP (CALXIA 500

)

GTL1286

12/2024

11/2026

M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC,

Kharedi, Dahod 389151, Gujarat.

Dissolution (for Calcium)

CDL, Kolkata

12.

Calcium Carbonate 500 mg +VIT. D3 250 IU

Tablets IP (CALXIA 500

)

GTL1298

12/2024

11/2026

M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC,

Kharedi, Dahod 389151, Gujarat.

Dissolution (for Calcium)

CDL, Kolkata

13.

Calcium Carbonate 500 mg +VIT. D3 250 IU

Tablets IP (CALXIA 500

)

GTL1301

12/2024

11/2026

M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC,

Kharedi, Dahod 389151, Gujarat.

Dissolution (for Calcium)

CDL, Kolkata

14.

Calcium Carbonate 500 mg +VIT. D3 250 IU

Tablets IP (CALXIA 500

)

GTL1302

12/2024

11/2026

M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC,

Kharedi, Dahod 389151, Gujarat.

Dissolution (for Calcium)

CDL, Kolkata

15.

Calcium Carbonate 500 mg +VIT. D3 250 IU

Tablets IP (CALXIA 500

)

GTL1303

12/2024

11/2026

M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC,

Kharedi, Dahod 389151, Gujarat.

Dissolution (for Calcium)

CDL, Kolkata

16.

Calcium Carbonate 500 mg +VIT. D3 250 IU

Tablets IP (CALXIA 500

)

GTL1304

12/2024

11/2026

M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC,

Kharedi, Dahod 389151, Gujarat.

Dissolution (for Calcium)

CDL, Kolkata

17.

Calcium Carbonate 500 mg +VIT. D3 250 IU

Tablets IP (CALXIA 500

)

GTL1305

12/2024

11/2026

M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC,

Kharedi, Dahod 389151, Gujarat.

Dissolution (for Calcium)

CDL, Kolkata

18.

Calcium Carbonate 500 mg +VIT. D3 250 IU

Tablets IP (CALXIA 500

)

GTL1306

12/2024

11/2026

M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC,

Kharedi, Dahod 389151, Gujarat.

Dissolution (for Calcium)

CDL, Kolkata

19.

Amikacin Sulphate Injection I.P. 500 mg

24AM18

10/2024

09/2026

M/s. SAI Parenterals Limited, D1 &D4, Survey No.280, Phase-V, IDA, Jeedimetla,

Hyderabad- 500055.Telangana, India

Particulate matter and Description

CDL, Kolkata

20.

Sucralfate & Oxetacaine Suspension (Rabeflux Suspension)

RBLS-02501

01/2025

12/2026

M/s. Tidal Laboratories Pvt. Ltd., Patch-5, Phase-II, Gowalthai, Distt. Bilaspur- 174201 (H.P.), INDIA

Identification, Assay of Sucralfate and Assay of Oxetacaine

CDL, Kolkata

21.

Iron Sucrose Injection USP 100mg/5ml

24RS15

12/2024

11/2026

M/s. SAI Parenterals Limited, D1 &D4, Survey No.280, Phase-V, IDA, Jeedimetla,

Hyderabad-500055, TS

pH and Alkalinity

CDL, Kolkata

22.

Iron Sucrose Injection USP 100mg/5ml

24RS03

01/2024

12/2025

M/s. SAI Parenterals Limited, D1 &D4, Survey No.280,

Phase-V, IDA, Jeedimetla, Hyderabad-500055, TS

pH

CDL, Kolkata

23.

Iron Sucrose Injection USP 100 mg/5ml

24RS06

02/2024

01/2026

M/s. SAI Parenterals Limited, D1 &D4, Survey No. 280, Phase-V, IDA, Jeedimetla, Hyderabad-500055, TS

pH and Alkalinity

CDL, Kolkata

24.

Compound Sodium Lactate Injection IP (RINGER-LACTATE SOLUTION FOR

INJECTION ) (RL)

1I245476

09/2024

08/2027

M/s. Aculife Healthcare Pvt. Ltd., Sachana, Gujarat- 382150, India

Sterility

CDL, Kolkata

25.

Rifampicin, Isoniazid and Ethmbutol Hydrochloride Tablets IP

TR-820008

07/2024

06/2026

M/s. Centurion Remedies Pvt. Ltd., G/5,6, B.I.D.C. Gorwa,

Vadodara -390016

Assay of Rifampicin

CDL, Kolkata

26.

Calcium Carbonate 500 mg + VIT. D3 250 IU

Tablets IP (CALXIA 500

)

GTL1294

12/2024

11/2026

M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC,

Kharedi, Dahod-389151, Gujarat.

Dissolution (for Calcium)

CDL, Kolkata

27.

Calcium Carbonate 500 mg + VIT. D3 250 IU

Tablets IP (CALXIA 500

)

GTL1299

12/2024

11/2026

M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC, Kharedi, Dahod-389151,

Gujarat.

Dissolution (for Calcium)

CDL, Kolkata

28.

Calcium Carbonate 500 mg + VIT. D3 250 IU Tablets IP (CALXIA 500)

GTL1300

12/2024

11/2026

M/s. Gidsha Pharmaceuticals, Plot No. 611 612, Mega GIDC,

Kharedi, Dahod-389151, Gujarat.

Dissolution (for Calcium)

CDL, Kolkata

29.

Ondansetron Oral Solution I.P. 2mg/5ml

ONES-1004

09/2024

08/2026

M/s. Wings Biotech, 43 and 44, HPSIDC, Industrial Area, Baddi-173 205 (H.P.)

Related Susbtances

CDL, Kolkata

30.

Gentamicin Injection IP (Gentatore Injection 80 mg/2ml)

IGMG418

07/2024

06/2026

M/s. Regain Laboratories, 134/5, HTM Road, Rajpur Lane, Hisar-125001, Haryana

Particulate matter and Description

CDL, Kolkata

31.

Teneligliptin & Metformin Hydrochloride (Sustained Release)

Tablets IP (Teglisure-M 500)

AOT244-00B

03/2024

02/2026

M/s. Astonea Labs Pvt. Ltd., Vill- Haripur, Teh. Raipur Rani, Dist. Panchkula, Haryana, INDIA-134204

Assay/content of Teneligliptin

CDL, Kolkata

32.

Cefpodoxime Proxetil Tablets I.P. 200 mg (BREPOD-200)

ST-25456

10/2024

09/2026

M/s. Sunvij Drugs Private Limited, 511, GIDC,

Waghodia, Baroda-391760, Gujarat

Dissolution

CDL, Kolkata

33.

Rabeprazole Sodium Injection IP

MD23H19

08/2023

07/2025

M/s. Martin & Brown Bio Sciences, K. No. 918/419, Malkumajra, Nalagarh Road, Baddi, Dist. Solan (H.P.)- 173205

pH, Particulate matter, Clarity of Solution, Assay of Rabeprazole

Sodium and Description

CDL, Kolkata

34.

Nimesulide & Paracetamol Tablets (Somu Gold)

TTX0093

01/2024

12/2026

M/s.Pro-pharma Care Pvt. Ltd., Khasara No. : 68, 69, 71, Village : Sikandarpur, Bhaiswal, Near Bhagwanpur,

Roorkee, Distt. Haridwar, Uttarakhand-247661

Dissolution

RDTL, Guwahati

35.

Fluconazole Tablets I.P. 150 mg (Megmazole-

150 Tablets)

TSF-C0116

01/2024

12/2025

M/s.Spen Formulations Pvt. Ltd., Plot No-123, Industrial Area, Mehatpur, Distt.

UNA174315 (H.P.)

Assay/Content of Fluconazole

RDTL, Guwahati

36.

Ampicillin Sodium Injection I.P. (AMPIVEE- 500 Injection)

TGDI082319 04

8/2023

07/2025

M/s.T & G Medicare, Village Kunjahal, PO Baddi, Distt:. Solan (H.P.)

Sterillity

RDTL, Guwahati

37.

Sulbactam Sodium Sterile I.P./USP.

23051901

5/2023

04/2026

M/s.Reyoung Pharmaceutical Co. Ltd., No.1,Ruiyang Road, Yiyuan Country,Shandong Province,P.R.China,Post Code:256100.Imported By: Shah TC Distribution LLP,Gala No.2 & 3, 1st Floor, BLD No. B1.H.No.709/2&709/3,Radha Krushna Compound,T.M. Industrial Park, Pimplas

Bhiwandi,MH-421302, India.

"Identification and Assay/Content of Sulbactam Sodium

RDTL, Guwahati

38.

Sulbactam Sodium Sterile I.P./USP.

23051806

5/2023

04/2026

M/s.Reyoung Pharmaceutical Co. Ltd., No.1,Ruiyang Road, Yiyuan Country,Shandong Province,P.R.China,Post Code:256100.Imported By: Shah TC Distribution LLP,Gala

No.2 & 3, 1st Floor, BLD No. B1.H.No.709/2&709/3,Radha Krushna Compound,T.M. Industrial Park, Pimplas

Bhiwandi,MH-421302, India

Identification and Assay/Content of Sulbactam Sodium

RDTL, Guwahati

39.

Sulbactam Sodium Sterile I.P./USP.

23051903

5/2023

04/2026

M/s.Reyoung Pharmaceutical Co. Ltd., No.1,Ruiyang Road, Yiyuan Country,Shandong Province,P.R.China,Post Code:256100.Imported By: Shah TC Distribution LLP,Gala No.2 & 3, 1st Floor, BLD No. B1.H.No.709/2&709/3,Radha Krushna Compound,T.M. Industrial Park, Pimplas

Bhiwandi,MH-421302, India.

Identification and Assay/Content of Sulbactam Sodium

RDTL, Guwahati

40.

Ciprofloxacin Tablets IP 250 mg (Ciprodac 250)

CT24001

2/2024

01/2027

M/s.CADILA PHARMACEUTICALS LIMITED, 1389, Dholka-

382225, Dist. Ahmedabad

Dissolution" of Ciprofloxacin

RDTL, Guwahati

41.

Ciprofloxacin Tablets IP 250 mg

CITB-02

7/2024

06/2026

M/s. NESTOR PHARMACEUTICALS

LIMITED, 11, Western Extension Area, Faridabad - 121 001, INDIA

Dissolution

RDTL, Guwahati

42.

Sulbactam Sodium Sterile I.P./USP

23051904

5/2023

04/2026

M/s.Reyoung Pharmaceutical Co. Ltd., No.1,Ruiyang Road, Yiyuan Country,Shandong Province,P.R.China,Post Code:256100.Imported By: Shah TC Distribution LLP,Gala No.2 & 3, 1st Floor, BLD No. B1.H.No.709/2&709/3,Radha Krushna Compound,T.M. Industrial Park, Pimplas

Bhiwandi,MH-421302, India.

Identification and Assay/Content of Sulbactam Sodium

RDTL, Guwahati

43.

Sulbactam Sodium Sterile I.P./USP.

23051902

5/2023

04/2026

M/s.Reyoung Pharmaceutical Co. Ltd., No.1,Ruiyang Road, Yiyuan Country,Shandong Province,P.R.China,Post Code:256100.Imported By: Shah TC Distribution LLP,Gala No.2 & 3, 1st Floor, BLD No. B1.H.No.709/2&709/3,Radha Krushna Compound,T.M.

Industrial Park, Pimplas Bhiwandi,MH-421302, India.

Identification and Assay/Content of Sulbactam Sodium

RDTL, Guwahati

44.

Albendazole Tablets IP 400 mg

LMT241100

9/2024

08/2026

M/s.Life Max Cancer Laboratories, Plot No. 106 & 106 A, Sector6A, IIE, SIDCUL,

Haridwar249403 (U.K)

Dissolution

RDTL, Guwahati

45.

Telmisartan I.P. 40 mg, Amlodipine Besylate I.P. 5 mg Tablets

ST 211

4/2024

03/2026

M/s.Soham Healhcare INC, Soham Healthcare Inc A-49, Sector-25, Gandhinagar, Gujarat

"Dissolution" (Telmisartan and Amlodipine) and "Assay/ content of Telmisartan and

Amlodipine"

CDTL-Mumbai

46.

Pioglitazone Hydrochloride Tablets (GLITO 15)

D40292

5/2024

04/2027

M/s.Medley Pharmaceuticals Ltd., Plot No. 18 & 19, Survey No.378/7 & 8, 379/2 & 3, Zari Causeway Road, Kachigam

Daman- 396210 (U.T), INDIA

"Dissolution"

CDTL-Mumbai

47.

Glimepiride Tablets I.P. 1 mg

12801124

8/2024

07/2026

M/s.Karnataka Antibiotics & Pharmaceuticals Limited (A Govt of India Enterprise), Plot No.14, II Phase, Peenya, Bengaluru - 560 058.

"Related substances"

CDTL-Mumbai

48.

Telmisartan & Hydrochlorothiazide Tablets IP (Telmijack-H)

T-20560

3/2024

02/2026

M/s.Jackson Laboratories Pvt. Ltd., Plot No. 56 & 61, Industrial Area, Phase III, Sansarpur Terrace, Distt.

Kangra (H.P.)- 176501.

"Related substances and Assay of Hydrochlorothiazi

de"

CDTL-Mumbai

49.

Sulphamethoxazole and Trimethoprim Tablets IP

MT386

10/2023

09/2026

M/s.Mayasha Lifesciences,

H.B. 86, Village-Bhatian

Nalagarh, Distt.-Solan (H.P.) 174101

Dissolution of Sulphamethoxazol e

RDTL,

Chandigarh

50.

Levamisole & Oxyclozanide Bolus Vet. (Wormizole Bolus)

EMVB-24162

10/2024

09/2026

M/s.Events Corporation, UNIT- II, Kala Amb, Tehsil Nahan, District Sirmour (H.P.)-173030

Disintegration test

RDTL,

Chandigarh

51.

Sodium Chloride Injection IP 0.9 %w/v

LV4979

11/2024

10/2026

M/s.Captab Biotec, Unit-II, Plot No.125, E.P.I.P. Road, Mauja,

Jharmajri, Baddi, Distt. Solan (H.P.)-173205

Bacterial endotoxins and Sterility

RDTL,

Chandigarh

52.

Sodium Chloride Injection IP 0.9 %w/v

LV4987

11/2024

10/2026

M/s.Captab Biotec, Unit-II, Plot No.125, E.P.I.P. Road, Mauja, Jharmajri, Baddi, Distt. Solan (H.P.)-173205

Bacterial endotoxins and Sterility

RDTL,

Chandigarh

53.

Sodium Chloride Injection IP 0.9 %w/v

LV4983

11/2024

10/2026

M/s.Captab Biotec, Unit-II, Plot No.125, E.P.I.P. Road, Mauja,

Jharmajri, Baddi, Distt. Solan (H.P.)-173205

Bacterial endotoxins and Sterility

RDTL,

Chandigarh

54.

Sodium Chloride Injection IP 0.9 %w/v

LV4984

11/2024

10/2026

M/s.Captab Biotec, Unit-II, Plot No.125, E.P.I.P. Road, Mauja, Jharmajri, Baddi, Distt. Solan

(H.P.)-173205

Bacterial endotoxins and Sterility

RDTL,

Chandigarh

55.

Sodium Chloride Injection IP 0.9 %w/v

LV4985

11/2024

10/2026

M/s.Captab Biotec, Unit-II, Plot No.125, E.P.I.P. Road, Mauja,

Jharmajri, Baddi, Distt. Solan (H.P.)-173205

Bacterial endotoxins and Sterility

RDTL,

Chandigarh

56.

Sodium Chloride Injection IP 0.9 %w/v

LV4982

11/2024

10/2026

M/s.Captab Biotec, Unit-II, Plot No.125, E.P.I.P. Road, Mauja, Jharmajri, Baddi, Distt. Solan (H.P.)-173205

Bacterial endotoxins and Sterility

RDTL,

Chandigarh

57.

Sodium Chloride Injection IP 0.9 %w/v

LV4978

11/2024

10/2026

M/s.Captab Biotec, Unit-II, Plot No.125, E.P.I.P. Road, Mauja,

Jharmajri, Baddi, Distt. Solan (H.P.)-173205

Bacterial endotoxins and Sterility

RDTL,

Chandigarh

58.

Sodium Chloride Injection IP 0.9 %w/v

LV4988

11/2024

10/2026

M/s.Captab Biotec, Unit-II, Plot No.125, E.P.I.P. Road, Mauja, Jharmajri, Baddi, Distt. Solan (H.P.)-173205

Particulate matter, Bacterial endotoxins and Sterility

RDTL,

Chandigarh

59.

Doxycycline Capsules IP 100 mg

B240705

05/2024

04/2026

M/s.Bochem Healthcare Pvt. Ltd., 83-84, Industrial Area, Dewas Road, Nagziri, Ujjain

45601-(M.P.) India

Dissolution of Doxycycline

RDTL,

Chandigarh

60.

Levetiracetam Tablets IP 500 mg

LMT241488

12/2024

11/2026

M/s.Life Max Cancer Laboratories Plot No. 106 & 106A, Sector-6A, IIE, SIDCUL,

Haridwar-249403 (U.K)

Dissolution

CDTL, Indore

The drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs. Further, the term ‘standards of quality’ is defined under the Section 16 (1) (a) of Drugs & Cosmetics Act, 1940, that the ‘standards of quality’ mean that the drug complies with the standards set out in the Second Schedule of the said Act.

For more details, check out the full story on the link below:

https://medicaldialogues.in/pdf_upload/cdsco-nsq-alert-for-the-month-of-april-2025-1-287801.pdf

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