List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of

AUGUST – 2023

Total number of samples tested

1166

Total number of samples declared as of Standard Quality

1118

Total number of samples declared as Not of Standard Quality

48

Total number of samples declared as Spurious

00

Total number of samples declared as Misbranded

00

S.No

Name of Drugs/medical device/cosmetics

Batch No.

Date of Manufa cture

Date of Expiry

Manufactured By

Reason for failure

Drawn By

From

1

MOL-PCB Syrup (Paracetamol, Bromhexine Hydrobromide Chlorpheniramine Maleate, Phenylephrine

Hydrochloride, Menthol Syrup) – 60 ml

L22541

03/2023

02/202

5

Aan Pharma Private Limited, 816/1, Pramukh Ind. Estate, Rakanpur 382 721, Ta. Kalol Dist. Gandhinagar (Guj.) India

pH, Assay of Bromhexine Hydrobromide and Phenylephrine Hydrochloride

CDSCO,

Ahmedaba d

CDL

Kolkata

2

Nifedipine Sustain Release Tablets I.P. 20 mg

T230307

03/2023

02/202

5

Medisky Pharmaceuticals Pvt. Ltd., Plot No. 260, GIDC, Talod – 383 215, Sabarkantha, Gujarat

Dissolution

CDSCO,

Ahmedaba d

CDL

Kolkata

3

DICLOGLOBE 50

(Diclofenac Sodium Tablets

I.P. 50 mg)

GT23026

01/2023

12/202

5

Globela Pharma Pvt. Ltd., 357, 358, G.I.D.C. Sachin,

Surat- 394 230, Gujarat, India

Disintegration

CDSCO,

Ahmedaba d

CDL

Kolkata

4

Trimax Expectorant (Terbutaline Sulphate with BromhexineHCl& Guaiphenesin),

23009

01/2023

10/202

4

Norris Medicines Limited, Plot No. 901/3-5, G.I.D.C. Estate,

Ankleshwar – 393 002 (Gujarat).

Assay of Bromhexine Hydrochloride &Menthol.This sample is found to contain 0.118% w/v of Ethylene Glycol and this sample does

not give positive test for Diethylene Glycol

CDSCO,

Ahmedaba d

CDL

Kolkata

5

Frusemide Injection IP (2ml)

AI22236

08/2022

07/202

4

Alves Healthcare Private Limited, NangalUperla, Swarghat Road, Nalagarh, Dist. Solan, Himachal Pradesh - 174101

pH

CDSCO,

Ahmedaba d

CDL

Kolkata

6

Refined Glycerin CP Grade

21100637

10/2021

09/202

5

Adani Wilmar, Pitampura, New Delhi – 110 034

Assay of Glycerin.Thi sample is found to contain 0.025% w/w of Ethylene Glycol and does not give positive result for

Diethylene Glycol

CDSCO,

Ahmedaba d

CDL

Kolkata

7

Sterile Noradrenaline Concentrate IP (2mg /1ml)

INABB23 01

04/2023

03/202

5

Samarth Life Sciences Pvt. Ltd., Unit II: Plot No.2, Industrial Area, Lodhimajra, Baddi, H.P. 173205, India

Description & Particulate Matter

CDSCO,

Ahmedaba d

CDL

Kolkata

8

CyproheptadineHCl with Tricholine Citrate Syrup (Sylpro Plus Syrup)

33002

05/2023

04/202

5

Norris Medicines Limited, Plot No. 801/P, 901/4-5, G.I.D.C.

Estate, Ankleshwar – 393 002 (Gujarat).

Assay of TricholineCitrate.This sample is found to contain Diethylene Glycol 0.243%w/v and Ethylene Glycol

0.171%w/v

CDSCO,

Ahmedaba d

CDL

Kolkata

9

Sibolone (Tibolone Tablets IP)

PLSB230 1

02/2023

09/202

5

Phaarmasia Ltd., Unit – II, Plot No. 145, Phase V, IDA, Jeedimetla (V), Qutubullapur (M), MedchalMalkajgiri (Dist.) 500 055

Dissolution

CDSCO,

Hyderabad

CDL

Kolkata

10

Methylprednisolone Sodium Succinate for Injection USP 40mg

22MS03

11/2022

10/202

4

SAI Parenterals Limited, D1 & D4, Survey No.280, Phase- V, IDA, Jeedimetla, Hyderabad- 500055, Telangana, India.

Uniformity of Dosage Units, Loss on Drying & Assay of Methylprednisolone Sodium Succinate

CDSCO,

Hyderabad

CDL

Kolkata

11

Misoprostol Tablets I.P. 200 mcg

22S1GTA

026

01/2022

12/202

3

Synokem Pharmaceuticals Ltd., Plot No.35-36, Sector- 6A, I.I.E (SIDCUL), Ranipur

(BHEL), Haridwar- 249403, Uttarakhand.

Assay

CDSCO

Bangalore

CDL

Kolkata

12

Cefotaxime for Injection IP 500 mg

CD22002

03/2022

02/202

4

Maan Pharmaceuticals Ltd., Plot-1, G.I.D.C., Phase II,

Modhera Road, Mehsana – 384 002, Gujarat, India

Particulate Matter & Clarity of Solution

CDSCO

Bangalore

CDL

Kolkata

13

Bacillus Clausii Spores Suspension (EbaniproSuspension)

AFL2258 8

08/2022

07/202

4

Aarmed Formulation Pvt. Ltd., Survey No. 431/2, Plot No.1, Steel Town, Moraiya, Tal. Sanand, Distt.

Ahmedabad (Gujarat)

Purity & Specified Pathogen (Pseudomonas aeruginosa)

Drug Control Departmen t Jammu & Kashmir

CDL

Kolkata

14

(Absorbable Surgical Suture

U.S.P (synthetic) 70 cm), (Monofilament Poliglecaprone 25) (STERGIC)

TV22212 7

09/2022

08/202

5

Sugii Surgical India Pvt. Ltd., No.3, Old No. 49/51, 8th Main, Peenya 2nd Stage, Bengaluru – 560058

Diameter

CDSCO

Bangalore

CDL

Kolkata

15

Erythromycin Stearate Tablets IP 250 mg

AT23118

04/2023

03/202

5

Alves Healthcare Private Limited, Village: NangalUperla, Swarghat Road, Tehsil, Nalagarh, Distt. Solan - 174101 (H.P.), India

Dissolution

CDSCO,

South Zone Chennai

CDL

Kolkata

16

Selamer-400 Tablets (Sevelamer Carbonate Tablets 400 mg)

MT22612 4B

12/2022

11/202

4

Mascot Health Series Pvt. Ltd, Plot No.79, 80, Sec-6A, IIE, Sidcul, Haridwar – 249 403, Uttarakhand, India.

Description

CDSCO,

South Zone Chennai

CDL

Kolkata

17

Telmisartan and Chlorthalidone Tablets

PF8C006

09/2022

08/202

4

Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27-30, Sector-8A, I.I.E., SIDCUL,

Ranipur Haridwar – 249 403, Uttarakhand

Dissolution of Chlorthalidone

CDSCO

East Zone Kolkata

CDL

Kolkata

18

AMTAS PRP (Amlodipine and Perindopril Tablets)

K2200008 2

01/2022

12/202

4

Intas Pharmaceuticals Ltd., Bhageykhola, Rangpo, East Sikkim -737132, India.

Assay of Perindopril Erbumine

CDSCO

East Zone Kolkata

CDL

Kolkata

19

Esylate (Etamsylate Injection 250 mg)

I-2359

12/2021

11/202

3

Jackson Laboratories Pvt. Ltd., Majitha Road, Amritsar 143001 (India).

Description, Particulate Matter & Extractable Volume

CDSCO

East Zone Kolkata

CDL

Kolkata

20

Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP (Montzer-C)

MTZ2200 3

12/2022

11/202

4

Tirupati Medicare Limited, Nahan Road, Paonta Sahib, Distt. Sirmour (H.P.) 173 205.

Dissolution of Montelukast

CDSCO

East Zone Kolkata

CDL

Kolkata

21

Nicomode-2 (Nicoumalone Tablets IP 2 mg)

T222932

02/2023

01/202

5

United Bioceuticals Pvt. Ltd., Plot No. 33C, Industrial Park IV, Begumpur, Haridwar - 249402, Uttarakhand

Related Substances

CDSCO

East Zone Kolkata

CDL

Kolkata

22

Erythromycin Stearate Tablets (Enthrocin-500)

ATG3A04 8

01/2023

12/202

4

Anrose Pharma, 147, Mauza Sansiwala, P.O. Barotiwala, Tehsil Kasauli, Distt. Solan (H.P.).

Dissolution

CDSCO

East Zone Kolkata

CDL

Kolkata

23

Cefoperazone & Sulbactam for injection

S3A099

01/2023

12/202

4

Arion Healthcare, GMP Certified Company Vill. Kishanpura, Baddi, Distt. Solan 174 101 (H.P).

Assay of Sulbactam

CDSCO

Hyderabad

CDL

Kolkata

24

Doxycycline and Lactic Acid Bacillus Capsules(DOXORIA-L)

SOC- 2062A

11/2022

10/202

4

Symbiosis Pharmaceuticals Pvt. Ltd., At C/o Ovation Remedies, Behind IITT Engg. College, Trilokpur Road, Kala Amb- 173030 (Sirmour), HP

Assay /Content of Gram positive rod shaped spore forming bacteria

CDSCO

East Zone Kolkata

CDL

Kolkata

25

Amoxycillin Capsules IP 500 MG (AMOXYCILLIN

500)

C-5076

Oct- 2022

Sep- 2024

Jackson Laboratories Pvt.Ltd., 22-24, Majitha Road, Bye Pass, Amritsar-143 001

TEST FOR DISSOLUTION

CDSCO

Subzone Bangalore

CDTL

Chennai

26

Ciprofloxacin Hydrochloride Tablets IP 500 mg

0700323

Feb- 2023

Jan- 2025

Karnataka Antibiotics & Pharmaceuticals Limited, Plot No.14, II Phase, Peenya, Bangalore-560058.

TEST FOR DISSOLUTION

CDSCO

South Zone Chennai

CDTL

Chennai

27

Ofloxacin & Metronidazole Benzoate Suspension (VIVFLOX-MZ Suspension) (For Paediatric USE ONLY)

PFS-1204

Nov- 2022

Oct- 2024

Proceed Formulations, 17, Ind. Area, Morthikri,

Ramgarh-Derabassi Road,, Derabassi – 140 201.

ASSAY OF METRONIDAZOLE BENZOATE AND OFLOXACIN

CDSCO

South Zone Chennai

CDTL

Chennai

28

Metronidazole & Ofloxacin Suspension (nor-metrogyl o Suspension)

XSWN22 006

April- 2022

Mar- 2024

Hema Laboratories Pvt. Ltd. Plot No.29, Pharma City, Selaqui Industrial Area,

Dehradun – 248 011 (State Uttarakhand)

ASSAY OF METRONIDAZOLE BENZOATE AND OFLOXACIN

CDSCO

South Zone Chennai

CDTL

Chennai

29

Ibuprofen and Paracetamol Dispersible Tablets (Ibucon Plus Kid)

C211143 003

March- 2023

Feb- 2026

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

Chikalthana, Aurangabad – 431 006

Diameter & Uniformity of Dispersion

CDSCO

West Zone Mumbai

CDTL

Mumbai

30

Calamine, Zinc Oxide, Aloe vera & Light Liquid Paraffin (Calmin Lotion)

C-012

Apr- 2022

March- 2025

Gladios Products Pvt Ltd., 31, Virat Industiral Estate, Dhanot, Gandhinagar, Gujarat – 382721

Specific gravity

CDSCO

Zonal Office

Ahmedaba d

CDTL

Mumbai

31

Lorazepam Tablets I.P. 2 mg

LZMT100 6

Feb- 2023

Jan- 2025

Unicure India Ltd., C-21, 22 & 23, Sector-3, Noida- 201301, Distt. : Gautam Budh Nagar (U.P.)

Dissolution and Assay

CDSCO

West Zone Mumbai

CDTL

Mumbai

32

Calcium and Vitamin D3 Tablets I.P.

KTB2176 AL

Nov - 2022

Apr- 2024

Karnataka Antibiotics & Pharmaceuticals Limited., Plot No.37, Site No.34/4, NTTF Main Road, 2nd Phase, Peenya Industrial

Area, Bengluru- 560058. At: Plot No. 5-9, Survey No.38/2,

Uniformity of content for Vitamin D3

CDSCO

West Zone Mumbai

CDTL

Mumbai

Aliyali Palghar (W), Dist. Palghar- 401404 (M.S).

33

Levocetirizine and Amrboxol Syrup (C & C Syrup)

BL23015

Feb- 2023

Jan- 2025

Baxil Pharma Pvt. Ltd., 10km, Nainital Highway, Shyampur, Haridwar 249408, Uttarakhand.

Assay of Ambroxol Hydrochloride

CDSCO

Ghaziabad

RDTL

Chandigarh

34

Povidone-Iodine Ointment USP 5% w/w

P1040

Aug- 2022

Jul- 2025

Babu Ram Om Prakash (BROP), Trilokpur Road, Ogli Village, Kala Amb,

Assay of Povidon Iodine calculated asAvailable Iodine

CDSCO

Ghaziabad

RDTL

Chandigarh

35

Cefpodoxime Proxetil for Oral Suspension IP

UCST- 2310

Mar- 2023

Feb- 2025

Ultra Drugs Pvt. Ltd., Manpura, Nalagarh, Distt.Solan-174101 (H.P.)

pH

CDSCO

Sub-Zone Jammu

RDTL

Chandigarh

36

Diclofenac Prolonged- Release Tablets IP 100 mg

CHT- 3037

Jan- 2023

Dec- 2024

Cotec Healthcare Pvt. Ltd., NH.No. 74, Roorkee- Dehradun Highway, Kishanpur, Roorkee-247667

(Uttarakhand)

Dissolution

CDSCO

Ghaziabad

RDTL

Chandigarh

37

Aspirin Gastro-resistant and Atorvastatin Capsules IP (75mg/10mg)

54CAT09

6

Sep- 2022

Aug- 2024

Swiss Garnier Life sciences, 21-23, Industrial Area, Mehatpur, Dist. Una, Himachal Pradesh- 174315.INDIA

Dissolution (buffer stage) of Aspirin and The Assay of Atrovastatin Calcium calculated as Atorvastatin

CDSCO

Ghaziabad

RDTL

Chandigarh

38

Mupirocin Ointment IP (MUPIJAI OINTMENT)

008

Sep- 2022

Aug- 2024

Baxil Pharma Pvt. Ltd., 10km, Nainital Highway, Shyampur, Haridwar 249408,

Assay of Mupirocin

Drug Control Departmen t Ghaziabad

RDTL

Chandigarh

39

The auto disable syringe (KOJAK SELINGE)

312053KJ M1

Mar- 2023

Feb- 2028

HINDUSTAN SYRINGES & MEDICAL DEVICES LTD., 174, 178/25, BALLABGARH, FARIDABAD, INDIA-121004

Design (Piston/Plunger Assembly) Fit of piston in barrel

CDSCO

Sub Zone Baddi

RDTL

Chandigarh

40

Rabeprazole Gastro- resistant Tablets IP (RABALKEM-20)

RBL2202 0RH

Oct- 2022

Sep- 2024

Ravian Life Science Pvt. Ltd., Plot No.34, Sector-8A, IIE, SIDCUL, Haridwar-249 403, Uttarakhand INDIA.

Dissolution

Drug Control Departmen t Assam

RDTL,

Guwahati

41

Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5ml syrup (COLD OUT)

SF001A0 1

Jan- 2022

Dec- 2024

Fourrts (India) Laboratories Pvt. Ltd., Vandalur Road, Kelambakkam-603 103.

Tamil Nadu, INDIA.

Content of Ethylene Glycol 1.9%w/v & Diethylene Glycol 0.14%w/v

CDSCO,

South zone, Chennai

RDTL

Guwahati

42

Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5 ml syrup (COLD OUT)

SF001B0 1

Feb- 2022

Jan- 2025

Fourrts (India) Laboratories Pvt. Ltd., Vandalur Road, Kelambakkam-603 103.

Tamil Nadu, INDIA.

Content of Ethylene Glycol 1.22%w/v

CDSCO,

South zone, Chennai

RDTL

Guwahati

43

Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5 ml syrup (COLD OUT)

SF001A0 2

Jan- 2022

Dec- 2024

Fourrts (India) Laboratories Pvt. Ltd., Vandalur Road, Kelambakkam-603 103.

Tamil Nadu, INDIA.

Content of Ethylene Glycol 2.23%w/v& Diethylene Glycol 0.17%w/v

Drugs Inspector, CDSCO,

South

zone, Chennai

RDTL

Guwahati

44

CALCIUM ACETATE TABLETS USP 667 mg.,

(Lanum)

D222313

Jul-2022

Jun- 2025

STANDFORD LABORATORIES PRIVATE

LIMITED, 8, Industrial Area, Mehatpur, Dist. Una, H.P. - 174315

Assay

Drugs Inspector, Guwahati, Assam

RDTL

Guwahati

45

GENTAMYCIN INJECTION

I.P. (GENTAVIK 2ml.)

TGL0223 0318

Feb- 2023

Jan- 2025

T & G MEDICARE, Village- Kunjahal, P.O. Baddi, Distt. Solan (H.P.)

Sterillity and Bacterial Endotoxins Test

lnspector of Drugs, Arunachal Pradesh

RDTL

Guwahati

46

Pantoprazole Gastro Resistant Tablets I.P. (PAVE -40)

BBT2217 94

May - 2022

Apr- 2024

Biomax Biotechnics (P) Ltd., 261, HSIIDC, Industrial Estate, Alipur, Barwala- 134118 (Haryana)

Dissolution

Drugs Inspector, RAnchii,Jh arkhand

RDTL

Guwahati

47

Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP (GLIMESTAR® M2 FORTE)

P9IAV007

Nov- 2022

Oct 2024

MANKIND PHARMA LTD.

Doring Block, Bermiok Elaka, Dist. Namchi, Sikkim 737126

Disintegration and Dissoluton

Drugs Inspector, Mizoram

RDTL

Guwahati

48

COMPOUND SODIUM LACTATE INJECTION I.P.

03BF173

7

Aug- 2022

Jul- 2025

PASCHIM BANGA PHARMACEUTICAL, NH-31 TIN MILE HAT, SONAPUR HAT, P.S.-CHOPRA, DIST:

UTTAR DINAJPUR, PIN- 733214 (W.B.)

Bacterial Endoxtoxins Test

Drugs Inspector, AJZAWL,

Mizoram

RDTL

Guwahati