84 Formulations declared Not of Standard Quality as per data provided by states: CDSCO Drug Alert

Published On 2025-01-26 12:30 GMT   |   Update On 2025-01-26 12:30 GMT

New Delhi: In line with the 'Not of Standard Quality' data provided by states, the apex drug regulatory body, the Central Drug Standard Control Organisation (CDSCO), in its latest drug safety alert, has flagged 84 medicine batches for failing to qualify for a random sample test for December 2024.

The list of drugs declared not of standard quality includes Cefpodoxime Tablets IP 200 mg (Jan Aushadhi) manufactured by Bharat Parenterals, CEFIXIME AND LACTIC ACID BACILLUS TABLETS (CFI200) manufactured by Swiss Biotech Parentrals, Pantacea 40 Tablets and Pantoprazole Gastro Resistant Tablets IP 40 mg manufactured by Windlas Biotech, Metoprolol Succinate Prolonged Release Tablets IP manufactured by Unicure India, Losartan Potassium Tablets IP 50 mg manufactured by Hindusthan Antibiotics, Ondansetron Injection IP-2ml manufactured by Skymap Pharamceuticals and others.

Furthermore, the list includes Gabacure Gel and Snikuf 4 manufactured by Akums Drugs and Pharmaceuticals, CIPRODAC 500 (Ciprofloxacin Tablets IP 500mg) manufactured by Cadila Pharmaceuticals, METFORMIN HYDROCHLORIDE TABLETS IP (OKAMET500) manufactured by Cipla.

Many 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.

In addition to the above, the alert mentioned that the Not of Standard Quality (NSQ) data was received as per Format and in EXCEL SHEET from State Drugs Licensing Authorities of Jammu Kashmir, Tamil Nadu, Himachal Pradesh, Puducherry, Telangana, Thiruvananthapuram (Kerala), Tripura, Ladakh, Karnataka.

Further, it added that NSQ data was received from West Bengal, Goa, as NIL. However, data was not received as per format in Excel Sheet from Assam (PDF Format), Rajasthan (PDF Format), Jharkhand (PDF Format), and Mizoram (PDF Format) for the Month of December 2024 as per DCG(I) Circular dated 09.02.2024.

In addition, the alert stated that State Drugs Licensing Authorities of Andhra Pradesh, Arunachal Pradesh, Bihar, Chhattisgarh, Gujarat, Haryana, Manipur, Meghalaya, Nagaland, Odisha, Punjab, Sikkim, Delhi, Uttarakhand, Andaman & Nicobar, Dadar and Nagar Haveli; Daman and Diu, Lakshadweep have not submitted any data in respect of the Not of Standard Quality (NSQ) Alert for the Month of December, 2024 as per DCG(I) Circular dated 09.02.2024.

NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF DECEMBER– 2024

B. State Laboratories

S.No

Product/Drug Name

Batch No.

Manufact uring

Date

Expiry Date

Manufactured By

NSQ Result

Reported by State Laboratory

1.

Divalproex Extended Release Tablets IP

(JKMSCL

Hospital Supply not for sale)

2406031

06/2024

05/2026

Biodeal Pharmaceuticals Ltd Vill Saini MajraNalagarhRopar Road , Nalagarh - 174101 , Distt. Solan

(H.P) India

Uniformity of Weights

DTL Srinagar (J&K) & MDTL Kathua (J&K)

2.

Divalproex Extended Release Tablets IP

(JKMSCL

Hospital Supply not for sale)

2407185

07/2024

06/2026

Biodeal Pharmaceuticals Ltd Vill Saini MajraNalagarhRopar Road , Nalagarh -

174101 , Distt. Solan (H.P) India

Uniformity of Weights

DTL Srinagar (J&K)

3.

Cefpodoxime Tablets IP 200 mg (Jan Aushadhi)

CT3096

09/2023

08/2025

Bharat Parenterals Ltd Survey No. 144-A, Jarod-SamlayaRoad

,Vill. Haripura , Tal.

Savil Dist. Vadodara - 391520 Gujarat India

Assay of Cefpodoxime

CFDL Jammu (J&K)

4.

DEXTROMETH ORPHAN HYDROBROMI

DE

AST- 23303

Aug-23

Jul-25

M/s.AASSK

Pharmaceuticals Pvt.

Ltd. Plot No.9, S.no 243/2,

On visual inspection dark spots are found on tablet

surface.Cappingand

Puducherry

PHENYLEPHRI NE HYDROCHLOR IDE & CHLORPHENIR AMINE MALEATE TABLETS

(Expal)

Dr.AmbedhkarStreet, Kozhumanivakkam, Mangadu, Chennai- 600 122

lamination defects are found. Some tablets were brittle on opening from the strip - NSQ

5.

BETAHISTINE DIHYDROCHL ORIDE TABLETS IP (CGHEST-8)

CT242502 84B

May-24

Apr-26

M/s CMG BIOTECH PVT. LTS (Unit-II),

Plot No. 58, PhaseIII, Industrial Area, Sansarpur Terrace, Tehsil Jaswan, Distt.Kangra, HP- 176501

On the received sample presence of spots were observed which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial

No.(i) Presence of Spot/discolouration

Puducherry

6.

METFORMIN HYDROCHLOR IDE TABLETS IP (OKAMET-

500)

4O30069

Feb-24

Jan-27

M/s.Cipla Ltd., Ropar Road, Nalagarh, Dist. Solan (H.P)-174 101

Does not comply with respect to the Assay as per IP specification

Puducherry

7.

PANTOPRAZO LE GASTRO- RESISTANT TABLETS IP

40mg (Pentowok)

WAM2401 1

May-24

Apr-26

M/s Admed Pharma Pvt Ltd., Plot No 87, HPSIDC, Industrial Area, Badddi, DisttSolan HP- 173

205

Does not comply with respect to the Disintegration test as per IP specification

Puducherry

8.

ZINC SULPHATE DISPERSIBLE

TABLETS IP

TH241106

Aug-24

Jul-26

M/s Orchid MedlifePvt. ltd., (WHO GMP & GLP

certified company)

On the received sample chipping and rough surface

defects were

Puducherry

20mg (CARE ZINC)

Vill.Kaundi,P.O Thane,

Khasra No. 646/513, Tehsil Baddi, Dist.

Solan (H.P)- 173 205.

observed, which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(V) and (VII)

respectively

9.

CEFIXIME AND LACTIC ACID BACILLUS TABLETS (CFI- 200)

T925

Sep-23

Aug-25

M/s. Swiss Biotech Parentrals., Kewat No. 1138,VPO -

Kachhwa, Karnal- 132001 (Haryana)

On the received sample presence of spots/discoloration observed which should not be present As per DCC Guidelines on Not Of Standard Quality (NSQ) Drugs Approved in 1993 (Annexure A) Tablets vide serial No.(i) Presence of

Spot/discoloration

Puducherry

10.

METFORMIN TABLETS IP

500 mg (GLYCIPHAGE)

G0374057

Jun-24

May-27

M/s.Franco-Indian Pharmaceuticals Pvt Ltd, 20, DR. E. Moses Road, Mumbai-400

011

Does not comply with respect to the Assay as per IP specification

Puducherry

11.

Ceaxil -500 Tablets, Cefuroxime Axetil Tablets IP

BT-227375

01/2024.

12/2025.

Dr Edwin Medilabs Pvt Ltd Plot No.B-29, Industrial Area, Focal Point, Chanalon, Kurali, SAS Nagar- 140103(Pb) PUNJAB

White coloured, elongated, biconvex tablets with score on one side, and plain on other side, 10 out of 50 tablets have brown-

coloured spots on

State Lab, Drugs Control Laboratory, Telangana.

the entire surface. Hence, the tablets failed the test for

Description of tablets.

12.

Jakclav-625 Tablets, Amoxicillin and Potassium Clavulanate Tablets

BPT-3002

02/2024.

01/2026.

Geenac Pharma Plot No: 582, Raipur, Bhagwanpur, Roorkee, Uttarakhand-247667. UTTARAKHAND

.

Mrkt By: WellnowHelathcare, Kanal Industrial Estate, Road No. 6, Borivali East,

Mumbai-400066.

The sample Does not meet the Specifications wrt. Identification test - Negative, Assay- Nil As per IP u/s. 17B of Drugs and Cosmetics Act 1940. the Sample deemed to be SPURIOUS and

Misbranded.

State Lab, Drugs Control Laboratory, Telangana.

13.

Jikcef-LB Tablets, Cefixime and Lactic Acid Bacillus Tablets

BPT-3005

02/2024.

01/2026.

GeenacPharma Plot No: 582, Raipur, Bhagwanpur, Roorkee, Uttarakhand-247667. UTTARAKHAND

.

Mrkt By: WellnowHelathcare, Kanal Industrial Estate, Road No. 6, BorivaliEast, Mumbai-

400066.

The sample does not meets the Specifications with respect to Identification test-Nil Assay-Nil

As per STP u/s. 17B of Drugs and Cosmetics Act 1940. The Sample deemed to be

SPURIOUS.

State Lab, Drugs Control Laboratory, Telangana.

14.

Jikcf-AZ Tablets, Cefixime and Azitromycin Tablets

BPT-3001

02/2024.

01/2026.

Geenac Pharma Plot No: 582, Raipur, Bhagwanpur, Roorkee, Uttarakhand-247667. UTTARAKHAND

.

The sample does not meets the Specifications with respect to Identification test-Nil

Assay-Nil

State Lab, Drugs Control Laboratory, Telangana.

Mrkt By: WellnowHelath care, Kanal Industrial Estate, Road No. 6, Borivali East,

Mumbai-400066.

As per STP u/s. 17B of Drugs and Cosmetics Act 1940. The Sample deemed to be

SPURIOUS.

15.

Vithrocin Suspension, Azithromycin Oral Suspension

AZ/L/01/40 09

08/2024.

07/2026.

Vital Therapeutics & Formulations Pvt.Ltd . Plot No. 47b/2, Phase-1, IDA, Cherlapally, Medchal- Malkajgiri District -

500051, Telangana, INDIA. Telangana

As sample failed with respect to test in pH as per IP further product is MISBRANDED

State Lab, Drugs Control Laboratory, Telangana.

16.

Pantacea 40 Tablets and Pantoprazole Gastro Resistant Tablets IP 40mg

PNTC3007

11/2023.

10/2025.

Windlas Biotech Limited Plant-2, Khasra No. 141 to 143 & 145,

MohabewalaIndl.area, Dehradun – 248110 (U.K.) UTTARAKHAND

Mrkt By: Panacea Life Sciences Limited, DCM Building, OffceNo.5, Seventh floor, 16 Barakhamba Road, Connauught place, New Delhi-

110001.

The sample Does not complies in respect of Dissolution Test as per IP.

State Lab, Drugs Control Laboratory, Telangana.

17.

Pantoprazole Sodium Tabletes IP 40mg

P01824

08/2024.

07/2026.

Spansules formulation India Pvt Ltd Sy. No. 172, Plot.No.154/A4 IDA

Bollaram (V), Jinnaram (M), Sangareddy (D),

Hyderabad

The sample Does not comply in respect of Dissolution Test as per IP.

State Lab, Drugs Control Laboratory, Telangana.

Telangana

18.

Metoprolol Succinate Prolonged Release Tablets IP

URDT0654

03/23

02/25

Unicure India Ltd., Plot No. 46(B)/49B Village Raipur, Bhagwanpur

,RoorkeeDist, Haridwar,

Uttarakhand

It fails the test

‘Assay’ as per IP standards [Amendment List - 05 to IP 2022]

Drugs Testing Laboratory Thiruvananthapuram

19.

Metoprolol Succinate Prolonged Release Tablets IP

URDT0653

03/23

02/25

Unicure India Ltd., Plot No. 46(B)/49B Village Raipur, Bhagwanpur

,RoorkeeDist,

Haridwar, Uttarakhand

It fails the test

‘Assay’ as per IP standards [Amendment List - 05 to IP 2022]

Drugs Testing Laboratory Thiruvananthapuram

20.

Metoprolol Succinate Prolonged Release Tablets IP

URDT0652

03/23

02/25

Unicure India Ltd., Plot No. 46(B)/49B Village Raipur, Bhagwanpur

,RoorkeeDist, Haridwar,

Uttarakhand

It fails the test

‘Assay’ as per IP standards [Amendment List - 05 to IP 2022]

Drugs Testing Laboratory Thiruvananthapuram

21.

Losartan Potassium Tablets IP 50 mg

HLOA09

11/23

10/25

Hindusthan Antibiotics Ltd, At 11, W.E.A, Faridabad - 121 001, Haryana

It fails the test ‘Dissolution’ as per IP as specified in

the Laboratory Protocol

Drugs Testing Laboratory Thiruvananthapuram

22.

Amoxymoon CV-625

[Amoxycillin and Potassium Clavulanate Tablets IP]

VT 241704

10/24

03/26

VADSP

Pharmaceuticals, Plot No.124, EPIP,

Indl.Area, Phase-1, Jharmajri, Baddi (H.P) 174 103

It fails the tests ‘Assay’ and ‘Dissolution’ for

Clavulanic Acid as per IP, as specified in the Laboratory

Protocol .

Drugs Testing Laboratory Thiruvananthapuram

23.

Balarishtam

107

09/24

10 Yrs. Form

packing

Alappat Pharma, Kollam-691503

It fails the test Total Solids and Specific

Gravity as per API

Drugs Testing Laboratory

Thiruvananthapuram

24.

Metformin

D2164/24-

Kerala Medical

It fails the test

Drugs Testing

Hydrochloride Sustained Release Tab IP 500 mg

25

Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram- 14

microbial contamination in Non-sterile products

and Descriptive part for tablets as per IP

Laboratory Thiruvananthapuram

25.

Paracetamol Tab IP 500 mg.

D2370/24- 25

Kerala Medical Services Corporation Ltd, Thycaud P.O, Thiruvananthapuram-

14

It fails the test ‘Dissolution’ as per IP

Drugs Testing Laboratory Thiruvananthapuram

26.

CIPRODAC 500

(Ciprofloxacin Tablets IP 500mg)

AN24014

Jan-24

Dec-26

Cadila Pharmaceuticals Limited, 1389, Dholka

– 382225, Dist:

Ahmedabad, At: A-1, Ratan Industrial Area, Harsuliya, Jaipur.

C/o. M/S. Anon Pharmaceutical, Jaipur. Mfg. Lic. No.:

RAJ/JPR/2718.

The Sample does not conform to standard in respect of the test "Dissolution" performed

State Drugs Testing Laboratory, Agartala, Tripura.

27.

Metoheal XL 25 (Metoprolol Succinate Extended

release Tablets U.S.P)

T24D800A

D/M:

Apr/2024

D/E:

Mar/2026

M/s. Bajaj Formulation, Khasra No.161, Village- LakeshwaryBhagwan

pur, RoorkeeDistt: Haridwar (UK)

Test for Dissolution” & content of Metoprolol Succinate in the Assay

Karnataka

28.

Panik-D Tablets (Pantoprazole Sodium &Domperidone

Tablets)

KPT24K08 A

D/M:02/2 024

D/E:01/202 6

M/s. Kaizen Pharmaceuticals, Vill. Katha, Baddi-173205 Distt. Solan (H.P)

test for Disintegration

Karnataka

29.

Fercobate-XT Suspension (Ferrous Ascorbate& Folic acid

Suspension)

240603

D/M:

Jun/2024

D/E:

Nov/2025

M/s. ShinestarPharma, Begapali Road, SIPOCT-1, Hosur- 635126 (T.N)

Folic Acid in the Assay and Misbranded

Karnataka

30.

CefpodoximePr oxetil Dispersible

Tablets (Qupod- 200 Tablets)

KCT- 403002

D/M:03/2 024

D/E:02/202 6

M/s. Knox Life Sciences, Vill. Gullarwala, Sai Road,

Baddi, Distt. Solan (H.P)

Test for Uniformity of Dispersion

Karnataka

31.

Calcium Carbonate & Vitamin D3 Tablets (Calcovit D3

Tablets)

MWT2311 80

D/M:

Jan/2024

D/E:

Dec/2025

M/s. MedworPharma, 140 EPIP, Phase-II,

Thana, Baddi 173205

Test for Dissolution for Calcium, Assay for Vitamin D3” and with respect to “Description

Karnataka

32.

Ranitidine Hydrochloride Injection I.P

AV3082

D/M: 02/2023

D/E: 01/2025

M/s. Alpa Laboratories Ltd., 33/2 A.B. Road, Pigdamber-453 446,

Indore (M.P)

Test for Sterility

Karnataka

33.

Cipex-500 (Ciprofloxacin Tabets I.P)

MUTAD23 01

D/M:

Jun/2023

D/E:

May/2026

M/s. Maxtar Bio- Genics, K.No.705, Nalagarh Road,

MalkuMajra, Baddi- 173205 (H.P)

Test for Dissolution only

Karnataka

34.

Terbicharge 250 mg (TerbinafineHyd rochloride

Tablets IP)

NT-4303

D/M: 06/2023

D/E: 05/2025

M/s. Neptune Life Sciences Pvt. Ltd., 100-B, EPIP, Phase-

II, Thana, Baddi- 173205 (H.P)

Test for Dissolution only

Karnataka

35.

Levocetirizin Hydrochloride &Montelukast Sodium Tablets IP (Montefirst-

LC)

2405097

D/M:

May/2024

D/E:

Apr/2026

M/s. Aban Pharmaceuticals, Plot No. 1018, Kerala, G.I.D.C., Bavla, Dist. Ahmedabad-382220

Test for Dissolution of Levocetirizine Hydrochloride and Montelukast

Karnataka

36.

Paracetamol Tablets IP 650 mg

PCT24135

D/M: 06/2024

D/E: 05/2026

M/s. VivekPharmachem (India) Ltd., NH-8, Chimanpura, Amer,

Jaipur-303102

Test for Dissolution

Karnataka

37.

Aluminium,

C21A1330

D/M:

D/E:

M/s. Concept

Description only

Karnataka

Magnesium &Simethicone Oral

Suspension I.P

03

06/2023

05/2026

Pharmaceuticals Ltd., A-28/3, MIDC,

Chikalthana,

Aurangabad-431006

38.

ITRACHARGE 200

(Itraconazole Capsules BP)

NC-0805

D/M: 06/2023

D/E: 05/2025

M/s. Neptune Life Sciences Pvt. Ltd., 100-B, EPIP, Phase-

II, Thana, Baddi- 173205 (H.P)

Dissolution Test only

Karnataka

39.

Ondansetron Injection IP-2ml

A24AM130

04/2024

03/2026

Skymap Pharamceuticals Pvt. Ltd, B-2 Dev Bhoomi Industrial Estate, Puhana Iqbalpur Road, Roorkee - 247

667

sample does not conform to requirement for assay and related substances

King Institute of Preventive Medicine & Research, Guindy, Chennai-32

40.

Cipladine Multipurpose Antiseptic Skin Ointment

CH040103

03/2024

02/2026

HSN International, At Plot No.54-55, Sector 6A, I.I.E, Sidcul, Haridwar, Uttarakhand,249403.

Sample does not conform to USP specification for povidone-Iodine Ointment with respect to content of available Iodine

in povidone Iodine.

Drugs Testing Laboratory, Chennai - 6

41.

Povidone- Iodine Ointment USP

VG24025

04/2024

03/2026

Microwin Labs PVt Ltd, Plot No.363, Industrial Focal Point, Phase-9, Mohali- 160062.

Sample does not conform to USP Spcification for povidine-IODINE Ointment with respect to the content of Avaible

Iodine in povidone Iodine.

Drugs Testing Laboratory, Madurai - 19.

42.

Atorvastatin Calcium Tablets IP 10mg

HTN414D

04/2024

03/2026

Himalaya Meditek Pvt. Ltd, Plot No. 35 & 36, Pharmacity, Selaqui, Industrial

Area, Dehradun - 248

Sample does not conform to IP Specification for Atorvastatin

Calcium Tablets

Drugs Testing Laboratory, Chennai - 6

197

with respect to

Dissolution

43.

Atorvastatin Calcium Tablets IP 10mg

HTN405D

04/2024

03/2026

Himalaya Meditek Pvt. Ltd, Plot No. 35 & 36, Pharmacity, Selaqui, Industrial Area, Dehradun - 248 197

Sample does not conform to IP Specification for Atorvastatin Calcium Tablets

with respect to Dissolution

Drugs Testing Laboratory, Chennai - 6

44.

Ciprofloxacin Hydrochloride Tablets IP 500mg

HTN1126L

11/2023

10/2025

Himalaya Meditek Pvt. Ltd, Plot No. 35 & 36, Pharmacity, Selaqui, Industrial Area, Dehradun - 248

197

Sample does not conform to IP specification for ciprofloxacin tablets with respect to

Dissolution

Drugs Testing Laboratory, Chennai - 6

45.

Amlod-At

DT240289

02/2024

01/2026

Daeiou Pharmaceutical (P) Ltd, R.S.No.158,

Puducherry - Villupuram Main Road, Villianur, Puducherry, 605110.

Sample does not conform to IP Specification for Amlodipine and Atenolol Tablets with respect to Dissolution for Amlodipine and to the Content of Amlodipine in Amlodipine in

Amlidipine Besylate.

Drugs Testing Laboratory, Chennai - 6

46.

Glimepiride Tablets IP 1mg

PGG24- 002

06/2024

05/2026

Pondchy Pharmaceuticals, R.S.No.218/4, 218/5,

Odiaampet, Manaveli Road, Villianur Commune,

Puducherry, 605110.

Sample does not conform to IP specification for Glimepiride Tablets with respect to Dissolution.

Drugs Testing Laboratory, Chennai - 6

47.

Snikuf 4

RZAB01

05/2023

04/2025

Akums Drugs & Pharmaceuticals Ltd, 22, Sector-6A, I.I.E,

Sidcul. Ranipur,

Sample does not conform to label claim with respect

to the content of

Drugs Testing Laboratory, Chennai - 6

Haridwar-249403,

Uttrakhand.

Terbutaline

Sulphate.

48.

Trubery LS

Z-23388

09/2023

08/2025

CSD Lifesciences, Village Malkumajra, Morepen Road, Baddi, Distt, Solan, (H.P). 173205.

Sample does not conform to Label with respect to the content of Levosalbutamol in

Levosalbutamol sulphate.

Drugs Testing Laboratory, Chennai - 6

49.

Sucrazum-O Suspension

ALL-899

08/2023

07/2025

Access Life Science, Khasra No.551/3, Village Taksal, Parwanoo, Distt,

Solan (HP), 173220.

Sample does not conform to Label claim with respect to the content of

Oxetacaine.

Drugs Testing Laboratory, Chennai - 6

50.

Rosuvastatin, Aspirin & Clopidogrel Capsules (20mg/75mg/75 mg)

MC240184

02/2024

01/2026

Mascot Health Series Pvt Ltd., Plot No. 79, 80 Sec-6A, IIE,

Sidcul, Haridwar- 249

403

Sample does not conform to Label claim with respect to the content of Aspirin and to Schedule V of Drugs and Cosmetics Act, with respect to free

Salicylic Acid.

Drugs Testing Laboratory, Chennai - 6

51.

Metoclopramide HCL Injection I.P-2ml

24DQC64

03/2024

02/2026

SVP Life Sciences, C/10-1, Sara Industrial Estate, Selaqui, Dehradun

sample does not conform to the requirement for

Assay of Metoclopramide

King Institute of Preventive Medicine & Research, Guindy, Chennai-32

52.

Metoclopramide HCL Injection I.P-2ml

HLI405D

04/2024

03/2026

Himalaya Meditek Pvt. Ltd, Plot No. 35 & 36, Pharmacity, Selaqui, Industrial Area, Dehradun - 248

197

sample does not conform to the requirement for Assay of Metoclopramide

King Institute of Preventive Medicine & Research, Guindy, Chennai-32

53.

Amitriptyline Tablets IP 25mg

TA24159

04/2024

03/2026

Saintlife

Pharmaceuticals Ltd, 323, Central Hope

Sample does not

conform to IP specification for

Drugs Testing

Laboratory, Chennai - 6

Town, Industrial Area, Selaqui, Dehradun - 248 011,

Uttarakhand, India

tablets with respect to Definition.

54.

Megapure-TZ IU suspension

23L-162

09/2023

08/2025

Prispag Pharma, Roomi, Jagraon - 142030.

Sample does not conform to label claim with respect to the content of Ciprofloxacin in Ciprofloxacin

Hydrochloride and Tinidazole.

Drugs Testing Laboratory, Chennai - 6

55.

Octenidine Dihydrochlordie Gel

PPKAC84

05/2023

04/2026

Pure & Cure Healthcare Pvt Ltd, (A Subsidiary of Akums Drugs & Pharmaceuticals Ltd,) Plot No.26A,27-30,

Sector - 8A,IIE,

Sidcul, Haridwar- 249403. Uttarakhand.

Sample does not conform to label claim with respect to the content of Octenidine Dihydrochloride.

Drugs Testing Laboratory, Madurai - 19.

56.

Dexamethasone Tablets IP 0.5mg

TA24036

01/2024

12/2025

Saintlife Pharmaceuticals Ltd, 323, Central Hope Town, Industrial Area, Selaqui, Dehradun - 248 011,

Uttarakhand, India

Sample does not conform to IP Specification for Dexamethasone Tablets with respect to the content of

Dexamethasone.

Drugs Testing Laboratory, Chennai - 6

57.

Dexamethasone Tablets IP 0.5mg

TA24035

01/2024

12/2025

Saintlife Pharmaceuticals Ltd, 323, Central Hope Town, Industrial Area, Selaqui, Dehradun - 248 011,

Uttarakhand, India

Sample does not conform to IP Specification for Dexamethasone Tablets with respect

to the content of Dexamthasone.

Drugs Testing Laboratory, Chennai - 6

58.

Peedon

P2409

05/2024

04/2026

Sharing formulations Pvt Ltd, Plot

No.41,G.I.D.C,

Sample does not conform to label

claim with respect

Drugs Testing Laboratory, Chennai -

6

Waghodia, Vadodara. 391760.

to the content of

Available Iodine in Povidone-Iodine.

59.

Esilac Soluion

ZBL-1154

12/2023

11/2025

Zoic Biotech Pvt Ltd, Plot No.C-15, Focal Point, Ind. Area, Chanalon, Mohali, (Punjab), 140103.

Sample does not conform to USP Specification for Lactulose Solution with respect to the Content of Lactulose in Lactulose

Concentrate.

Drugs Testing Laboratory, Chennai - 6

60.

Amoxycillin Dispersible Tablets IP 125 mg

PGA24- 002

03/2024

02/2026

Pondchy Pharmaceuticals, R.S.No.218/4, 218/5,

Odiaampet, Manaveli Road, Villianur Commune, Puducherry, 605110.

Sample does not conform to IP Specification for Dispersible Tablets with respect to uniformity of Dispersion and

Disintegration

Drugs Testing Laboratory, Chennai - 6

61.

Orsiclop-A75

NTT24103 6

03/2024

02/2026

Nanoceut Therapeutics Pvt Ltd, R.S.No. 104/19A,

E.V.R.Street, Sedarapet, Puducherry, 605111

Sample does not conform to IP specification for Clopidogrel and Aspirin Tablets with respect to Dissolution ( Clopidogrel and Aspirin), Free Salicylic Acid (Related substance for Aspirin) and to the content of

ASpirin

Drugs Testing Laboratory, Chennai - 6

62.

Iron Sucrose Injection USP- 5ML

PGY23118

08/2023

07/2025

Affy Parenterals, Vill. Gullerwala, P.O. Baddi, Distt. Solan -

173 205 (H.P)

Sample does not conform to requirement for

assay for iron.

King Institute of Preventive Medicine & Research,

Guindy, Chennai-32

63.

Justkof-LS

UF267408 2F

01/2024

12/2025

Ultra Drugs Formultations Pvt Ltd, Plot No.338/278, Vill. Manakpur, Lodhimajra, Tehsil-

Baddi, Distt. Solan (HP)-173205.

sample does not conform to Label claim with respect to the content of Ambroxol Hydrochloride.

Drugs Testing Laboratory, Madurai - 19.

64.

Gabacure Gel

HUAA46

06/2024

11/2025

Akums Druges & Pharmaceuticals Ltd. 47,48,Sector-6A, I.I.E., SIDCUL,,

Haridwar-249 403, Uttarakhand.

Sample does not conform to Label claim with respect to the content of Gobapentin.

Drugs Testing Laboratory, Madurai - 19.

65.

Dexamethasone Injection IP-2ml

FDDTI-004

02/2024

01/2026

Laborate Pharmaceuticals India

Ltd, 51 Indl. Area, Paonta Sahib (HP).

Sample does not conform to

requirement for Assay.

King Institute of Preventive Medicine

& Research, Guindy, Chennai-32

66.

Ondansetron Tablets IP 4 mg

320D2401

04/2024

03/2026

SSM Formulations Private Limited, Survey No. 11/1, Mouza Ashti (Rith), Hinganghar (M.H),

442301

Sample does not conform to IP Specification for Ondansetron Tablets with respect

to Dissolution.

Drugs Testing Laboratory, Chennai - 6

67.

O Mak-200

VMWT240 7

06/2024

03/2026

Vertex Pharma Chemicals, Plot No.60-A,61-A,

PIPDIC Electronic Park, Tirubhuvanai, Puducheryy-605107.

Sample does not conform to IP Specification of Ofloxacin Tablets with respect to the content of

Ofloxacin.

Drugs Testing Laboratory, Madurai - 19.

68.

Retrazith-250

WT3927F

03/2024

02/2026

Saphnix Life Sciences, Village- Barotiwala, Paonta Sahib,Distt, Siramour, Himachal Pradesh- 173025

Sample does not conform to IP specification for Azithromycin Tablets with respect to Dissolution and to the Content of

Anhydrous

Drugs Testing Laboratory, Chennai - 6

Azithromycin

Dihydrate.

69.

Surgi Spirit

SS-084032

08/2024

07/2026

Transflex, Hawahar Nagar, Ranipur (C.G),492001.

Sample does not conform IP Specifciation for Surgical Spirit with respect to weight

per ml.

Drugs Testing Laboratory, Chennai - 6

70.

Brokuf-DM

CBL- 0024/24

02/2024

01/2026

C.B.Healthcare, Village Messa Tibba, Tehsil Nalagarh, Distt, Solan (H.P),174101.

Sample does not conform to Label claim with respect to the content of phenylephrine

Hydrochloride.

Drugs Testing Laboratory, Chennai - 6

71.

Tamcof-Ls Syrup

AGL23022 1C

03/2024

02/2026

Asterisk Healthcare,

V.P.O Bathri, Thesil Haroli, Distt. Una (H.P),174301.

Sample does not conform to Label claim with respect to the content of Ambroxol

Hydrochloride

Drugs Testing Laboratory, Chennai - 6

72.

Cadcof-Lx Syrup

DLS2378

06/2024

05/2026

Dhwanilife Care Pvt Ltd, Plot No.C-20/2, (C-39) & C-20/3, (C-

40), Arvind Mega Parek, Village- Chachravadi Vasna, Ahmedabad, Gujarat- 382213.

Sample does not conform to Label Claim with respect to the content of Levosalbutamol in Levosalbutamol Sulphate, Ambroxol

Hydrochloride and Guaiphenesin.

Drugs Testing Laboratory, Chennai - 6

73.

Co-Trimoxazole Tablets IP 480mg

MT404

01/2024

12/2026

Maxwell Lifescience Pvt Ltd, T-53 & T-81,

M.I.D.C, Tarapur, Boisar, Dist, Palghar, 401506.

Sample does not conform to IP Specification for Co- Trimoxazole Tablets with respect to

Dissolution for Sulphamethoxazole

Drugs Testing Laboratory, Chennai - 6

74.

Cipladine

CHO40018

01/2024

12/2025

HSN International, At point No.54-55,

Sample does not conform to USP

Drugs Testing Laboratory, Madurai -

Sector 6A, I.IE, Sidcul Haridwar, (Uttarakhand), 249403

Specification for Povidone- Iodine Ointment with respect to the content of Avaible

Iodine in Povidone Iodine,

19.

75.

Cipladine Ointment

CHO40020

01/2024

12/2025

HSN International, At point No.54-55, Sector 6A, I.IE, Sidcul Haridwar, (Uttarakhand), 249403

Sample does not conform to USP Specification for Povidone-Iodine Ointment with respect to the content of Avaible Iodine in Povidone

Iodine.

Drugs Testing Laboratory, Madurai - 19.

76.

Atovaris-F

DEMT- 240124B

04/2024

03/2026

Dr.Edwin Medilabs Pvt Ltd, Plot No.B-29, Industrial Area, Focal Point, Chanalon, Kurali, SAS Nagar-

140103(pb).

Sample does not conform to IP Specification with respect to Uniformity of

Weight.

Drugs Testing Laboratory, Madurai - 19.

77.

Capiwash Mouthwah

FL-050B

08/2023

07/2025

Forgo Pharmaceuticals, 27, Dic Ind Area, Barotiwala, the Baddi, Distt, Solan (H.P)- 174103

Sample does not conform to IP Specification for Chlorhexidine Mouthwash IP with respect to the content of Chlorhexidine Gluconate in

Chlorhexidine Gluconate Solution.

Drugs Testing Laboratory, Madurai - 19.

78.

Povidone- Iodine Ointment USP

VG23017

11/2023

10/2025

Microwin Labs PVt Ltd, Plot No.363, Industrial Focal Point, Phase-9, Mohali-

160062.

Sample does not conform to USP Specification for Povidone - Iodine

Ointment with

Drugs Testing Laboratory, Madurai - 19.

respect to the content of Avaible Iodine in Povidone

Iodine.

79.

Flucent Pour-on Solution

PB-105/12

12/2023

11/2025

Indo Gulf Pharmaceuticals, 5.4 K.M, Meerut Road, Muzaffarnagar (U.P)

Sample does not conform to Label claim with respect to Identification and

Content of Flumethrin.

Drugs Testing Laboratory, Madurai - 19.

80.

Betamethasone Valerate Ointment IP 01% w/w

B06

05/2024

04/2026

Syndicate Pharma, 185/B, 185/B-1, 187/A

& 188, sector -F, Sanwer Road, Indore- 452015.

Sample does not conform to IP specification for Betamethasone Valerate Ointment with respect to the content of Betamethasone in Betamethasone

Valerate.

Drugs Testing Laboratory, Madurai - 19.

81.

Clobium Suspension. Clobazam Oral Suspension BP 5mg

TYOL-047

07/2024

06/2026

Tanmed Pharma (I) Pvt Ltd, No.1/429, Multi Industrial Nagar, Gerugambakkam, Chennai-600128

Sample does not conform to BP specification for Clobazam Oral Suspension with respect to Dissolution and to

the content of Clobazam

Drugs Testing Laboratory, Chennai- 6

82.

Chlorpheniramin e Maleate Injection

IAL77/23

12/2023

11/2025

Anra Pharamaceuticals Pvt Ltd, Madurai-Melur Road, Vellaripati,

Madurai-625122

Sample does not conform to the requirement for Assay for

Chlorpheniramine

King Institute of Preventive Medicine & Research, Guindy, Chennai-32

83.

Chro-B Gold

DCBGT- 2402

09/2024

02/2026

Kniss Laboratories

(P) Ltd, Plot No. 9, Multe Industrial

Estate,

Sample does not conform to label claim with respect

to the content of

Drugs Testing Laboratory, Chennai - 6

Gerugambakkam,

Chennai - 600 128

Cholecalciferol

84.

Atorvastatin Tablets IP 10mg

A283

04/2024

03/2026

Rikenbik Pharma, 113, SIDCO Industrial Estate, Ambattur, Chennai-600098.

Sample does not conform to IP Specification for Atorvastatin Calcium Tablets

with respect to Dissolution.

Drugs Testing Laboratory, Chennai - 6

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