CDSCO Drug Alert: 61 Drug Samples Including Emcure's Levocarnitine Inj Flagged

Published On 2023-11-24 12:30 GMT   |   Update On 2023-11-24 16:21 GMT
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New Delhi: In its latest drug alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), has flagged 61 medicine batches for failing to qualify for a random drug sample test for the month of October.

These drug samples which are declared not of standard quality include Cefixime Oral Suspension IP manufactured by Maxmed Lifescience, Amoxycillin, Potassium Clavulanate and Lactic Acid Bacillus Tablets manufactured by Soft Touch Pharmaceuticals, Fluconazole Tablets manufactured by Bonsai Pharma, Leucovorin Calcium Injection manufactured Affy Parenterals and others.

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Apart from this, the list further includes Bisoprolol Fumarate Tablets USP 2.5 mg (BISELECT 2.5) manufactured by Intas Pharmaceuticals, Levocarnitine Injection U.S.P. (REE) manufactured by Emcure Pharmaceuticals.

This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1105 samples. Out of these, 1044 samples were found to be of standard quality while 61 of them were declared as Not of Standard Quality (NSQ).

A few of the reasons why the drug samples tested failed were the presence of the water content, failure of the assay, failure of the dissolution test etc.

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

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of October– 2023.

Total number of samples tested

- 1105

Total number of samples declared as of Standard Quality

- 1044

Total number of samples declared as Not of Standard Quality

- 61 (02 samples for Serial No. 4 & 02 samples for Serial No. 43)

Total number of samples declared as Spurious

- 0

Total number of samples declared as Misbranded

- 0

S.No

Name of Drugs/medical device/cosmetics

Batch No.

Date of Manufacture

Date of Expiry

Manufactured By

Reason for failure

Drawn By (From

state/CDSCO Zone)

From (Name of Laboratory)

1

Cefixime Oral Suspension IP

23CS012

Feb-2023

Jan-2025

MAXMED LIFESCIENCES PVT.LTD., Plot No.54, & 55 Sector-IIDC, SIDCUL,

Rudrapur, (Uttarakhand) India

Water content

CDSCO (North Zone), Ghaziabad

RDTL,

Chandigarh

2

Amoxycillin, Potassium Clavulanate and Lactic Acid Bacillus Tablets (GAMPCLAV-625 LB

Tablets)

BT-000142

Oct-2022

Mar-2024

Soft Touch Pharmaceuticals India Ltd., Plot No.8, Industrial Area, Waknaghat, Distt, Solan

(H.P.)-173234

Assay of Potassium Clavulate Diluted eq. to Clavulanic Acid

State FDA, District Bilaspur H.P.- 174001

RDTL,

Chandigarh

3

Fluconazole Tablets IP (Aclohix-400 Tablets)

MAY 23142

May-2023

Apr-2025

Bonsai Pharma, Kishanpura, Baddi- Nalagarh Road, P.O.Gurumajara, Distt. Solan (H.P.)

Dissolution

O/o State Drugs Controller,

H.Q. Baddi, Distt. Solan,

HP-173205

RDTL,

Chandigarh

4

Unlabeled vials with white seal purported to contains Tigecycline 50 mg

Unlabeled

NM

NM

Affy Parenterals, at Village Gullarwala, Sai Road, Baddi, Distt. Solan (H.P.)

Assay of Tigecycline

CDSCO Sub

Zone Baddi

RDTL,

Chandigarh

5

Leucovorin Calcium Injection IP (Medivorin Injection)

LCL0322A1

Mar-2022

Feb-2024

Affy Parenterals, at Village Gullarwala, Sai Road, Baddi, Distt. Solan (H.P.)

Extractable volume, Particulate matter and pH

CDSCO Sub

Zone Baddi

RDTL,

Chandigarh


6

Digoxin Injection BP (Digiver Injection)

E1582203

Jul-2022

Jun-2024

Verve Human Care Laboratories, 15-A, Pharmacity, Selaqui,

Dehradun-248011 (Uttarakhand) INDIA

Ethylene Glycol and Diethylene Glycol

CDSCO Sub

Zonal Office Rishikesh, Uttarakhand

RDTL,

Chandigarh

7

Rabeprazole Sodium (Enteric Coated) and Domperidone (Sustained Release) Capsules (20 mg/30

mg)

RPE-2285

Aug-2022

Jul-2024

Apple Formulation Private Limited, Plot No. 208, Kishanpur, Roorkee- 247667 (UK)

Assay of Rabeprazole Sodium

CDSCO (North Zone), Ghaziabad

RDTL,

Chandigarh

8

Aceclofenac, Paracetamol and Serratiopeptidase Tablets (Pain Free-SP Tablets)

UTA-22350

Aug-2022

Jul-2024

UPKAR PHARMACEUTICALS,

101, Industrial Area, Gondpur, Paonta Sahib, Distt. Sirmour (H.P.) 173205

Assay of Serratiopeptidase

O/o Drugs Control Officer, District Kargil Qatligarh Kargil-194103

(UT Ladakh)

RDTL,

Chandigarh

9

Propylene Glycol IP

PG-IP/2021- 22/2331

Nov-2021

Oct-2026

Manali Petrochemicals Limited, Plant II, Sathangadu Village, Manali,Chennai-600068

Identification A, Identification B, Identification C, Relative Density, Refractive Index, Ethylene Glycol and Diethylene Glycol and Water

Content

State FDA, O/o CMO, Solan, Distt.Solan (HP)-173212

RDTL,

Chandigarh

10

Diclofenac Sodium Tablets IP 50 mg

DBE14

Mar-2023

Feb-2025

RPL (INDIA)

Pharmaceuticals Pvt. Ltd., WHO-GMP CERTIFIED COMPANY D-8/5 & D-

8/6, Okhla Insutrial Area, Phase-1, New Delhi- 110020

Description

CDSCO (North Zone), Ghaziabad

RDTL,

Chandigarh

11

Calcium Carbonate and Vitamin D3 Tablets IP (Calimed Tablets)

LV22HT-863

Aug-2022

Jan-2024

L.V.LIFE SCIENCES,

VPO Gurumajra, Baddi, Distt. Solan (H.P.)- 174101

Assay of Vitamin D3

State FDA, District

Bilaspur H.P.- 174001

RDTL,

Chandigarh


12

Glimepiride Tablets IP 1 mg

GPG-531

Apr-23

Mar-25

Healers Lab, Unit II, Plot No.33, H.P.S.I.D.C., Extn.,

Baddi, Distt. Solan (H.P.)

Dissolution

CDSCO,

Zonal- Office, Ahmedabad

CDTL-

Mumbai

13

Etamsylate Tablets 250 mg (Fixoheam-250)

WF123001G

Mar-23

Feb-25

Windlas Biotech Limited., (Plant-2), Khasra No 141 to 143 & 145, Mohabewala Industrial Area, Dehradun-

248110, Uttarakhand

Hardness

CDSCO, West-

Zone, Mumbai

CDTL-

Mumbai

14

Albendazole Tablets

I.P. 400 mg

C21F943011

Aug-23

Jul-26

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

Chikalthana, Aurangabad- 431 006.

Dissolution

CDSCO, West-

Zone, Mumbai

CDTL-

Mumbai

15

Isoniazid Tablets IP 300 mg (Isocon -300)

C21I263005

Jul-23

Jun-27

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

Chikalthana, Aurangabad- 431 006.

Assay

CDSCO, West-

Zone, Mumbai

CDTL-

Mumbai

16

Ofloxacin & Ornidazole Tablets

I.P. (O2)

E20512

04/2022

03/2025

Medley Pharmaceuticals Ltd., Lane No.3, Phase- 1, SIDCO Industrial Complex, Bari Brahmana, Jammu - 181

133.

Description

State FDA, Odisha, Sambalpur Range, Odisha

CDL,

Kolkata

17

Vancomycin Hydrochloride for Intravenous Infusion IP (Sosvanco Injection)

HIVC23001A

01/2023

12/2024

Health Biotech Ltd., Village Sandoli, Nalagarh Road, Baddi, Distt: Solan (H.P.) India- 173205.

Description, Appearance of Solution, Clarity of Solution &

Particulate Matter

State FDA, Odisha, Balangir Range,

Balangir, Odisha

CDL,

Kolkata

18

Adrenaline Bitartrate Injection I.P. (ADREN)

MDN2302A

04/2023

03/2024

Medilife Health Sciences Pvt. Ltd., At- Surajpur, Paonta Sahib,

Dist.- Sirmour (H.P.)- 173001.

Description & Particulate Matter

State FDA, Odisha, Cuttack I

Range, Odisha

CDL,

Kolkata


19

Unlabeled bottles purported to contain Amoxycillin 200 mg and Clavulanic acid

28.5 mg

Unlabeled

Not Mentioned

Not Mentioned

Affy Parenterals, At: Vill. Gullerwala, Sai Road, Baddi, Distt. Solan (H.P.)

Content of water

CDSCO,

Baddi

CDL,

Kolkata

20

Levetiracetam Oral Solution IP

RL230004

01/2023

12/2024

Ridley Life Sciences Pvt. Ltd., Unit II: D- 1566, DSIDC, Indl.

Complex, Narela, Delhi- 110040.

Description

CDSCO,

Baddi

CDL,

Kolkata

21

Unlabeled unpacked soft gelatin capsules purported to contain Vitamin D3, 60000

IU

Not Mentioned

Not Mentioned

Not Mentioned

Affy Parenterals, At: Vill. Gullerwala, Sai Road, Baddi, Distt. Solan-173205 (H.P.)

Assay of Vitamin D3

CDSCO,

Baddi

CDL,

Kolkata

22

Aceclofenac & Paracetamol Oral Suspension (SIGAFENAC-P)

L3C152

03/2023

02/2025

Smayan Healthcare Pvt. Ltd., Plot No. 26-27, HPSIDC Ind. Area, Vill. Davni, Baddi, Distt. Solan, H.P. - 173205

Assay of Aceclofenac & Paracetamol

CDSCO, Baddi

CDL,

Kolkata

23

Cholecalciferol Soft Gelatin Capsules 60000 IU (Fexit-D3)

PSG23161

07/2023

06/2025

Affy Parenterals, (WHO- cGMP/ ISO 9001: 2015

Certified Co.), Vill. Gullerwala, PO- Baddi, Distt. Solan -173205 (H.P.)

Assay of Cholecalciferol

CDSCO, Baddi

CDL,

Kolkata

24

Amikacin Injection IP 100 mg (AMICOS-100)

L-22058B

03/2023

02/2025

Symbosis Pharmaceuticals Pvt. Ltd., Suketi Road, Kala Amb Distt. Sirmour, Himachal Pradesh - 173030

Description, Sterility & Particulate Matter

CDSCO, Baddi

CDL,

Kolkata

25

Ambroxol HCl, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup (Toscof-

TR)

L3H148

08/2023

07/2025

Smayan Healthcare Pvt. Ltd., Plot No. 26-27, HPSIDC Indl. Area, Vill. Davni, Baddi, Distt. Solan,

H.P. - 173205

Assay of Menthol

CDSCO, Baddi

CDL,

Kolkata


26

Ofloxacin, Ornidazole, Itraconazole & Clobetasol Propionate Cream (Derma-RX Cream)

E3H021

08/2023

07/2025

Smayan Healthcare Pvt. Ltd., Plot No. 26-27, HPSIDC Indl. Area, Vill. Davni, Baddi, Distt. Solan, H.P. - 173205

Assay of Clobetasol Propionate

CDSCO, Baddi

CDL,

Kolkata

27

Etoricoxib & Thiocolchicoside Tablets (ATOCOX-MR Tablets)

DMT1202B

08/2023

07/2025

DM Pharma Private Limited (WHO GMP & ISO APPROVED), NH-

21A, Vill. Bhud, Baddi,

District Solan, (H.P.) 173205.

Assay of Thiocolchicoside

CDSCO, Baddi

CDL,

Kolkata

28

Pregabalin & Methylcobalamin Capsules IP

CHC-3062

08/2023

07/2025

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

247667, (Uttarakhand).

Uniformity of content of Methylcobalamin

CDSCO, Sub-

Zone, Rishikesh

CDL,

Kolkata

29

Rabeprazole Sodium (EC) and Domperidone (SR) Capsules (Rabihal DSR Capsule)

ZCN3G04

07/2023

06/2025

Zaneka Healthcare Ltd., BHEL Ancillary Estate, Ranipur, Haridwar- 249403 (U.K.)

Dissolution of Rabeprazole Sodium (Buffer Stage)

CDSCO, Sub-

Zone, Rishikesh

CDL,

Kolkata

30

Vitamin C (Orange Syrup)

MBL-063

09/2022

08/2024

Mednext Biotech Limited, Araji No. 1845-46-47,

Near Jain Temple, Iswal, Udaipur - 313011 (India).

Assay of Ascorbic Acid

CDSCO, North Zone

CDL,

Kolkata

31

Cough Syrup (ANYKOF)

ML23073

05/2023

04/2026

Mednext Biotech Limited, Araji No. 1845-46-47,

Near Jain Temple, Iswal, Udaipur - 313011 (India).

Assay of Bromhexine Hydrochloride & Menthol

CDSCO, North Zone

CDL,

Kolkata

32

Bisoprolol Fumarate Tablets USP 2.5 mg (BISELECT 2.5)

V2300382

04/2023

03/2025

Intas Pharmaceuticals Ltd., 7/3, GIDC Estate, Vatva Ahmedabad 382445 (India).

Dissolution & Assay

CDSCO,

Ahmedabad

CDL,

Kolkata

33

Metoprolol Succinate Prolonged-Release Tablets I.P. 25 mg

TGME22006

12/2022

11/2024

Ravian Life Science Pvt. Ltd., Plot No. 34, Sector- 8A, IIE, SIDCUL,

Haridwar 249 403, Uttarakhand

Dissolution

CDSCO, South Zone

CDL,

Kolkata


34

Tacrolimus Ointment 0.03% (Tacromed 0.03 Ointment)

HTO203

05/2022

04/2024

Med Manor Organics Pvt. Ltd., Unit-II, Kh.

No.143M/7, Village- Raipur, Pargana- Bhagwanpur, Tehsil- Roorkee, Dist. Haridwar,

Uttarakhand 247 661.

Assay

CDSCO,

Hyderabad

CDL,

Kolkata

35

Amikacin Sulphate Injection I.P. 500 mg

7900323

03/2023

02/2025

Karnataka Antibiotics & Pharmaceuticals Limited (A Govt. of India Enterprise), Plot No. 14, II

Phase Peenya Bengaluru- 560058, India.

Description & Particulate Matter

CDSCO, East Zone

CDL,

Kolkata

36

Levocarnitine Injection

U.S.P. (REE)

ELF8BH3004

07/2023

06/2026

Emcure Pharmaceuticals Ltd., J-174, J-168 & J-

168/1, MIDC Tarapur, Boisar, Dist. Thane- 401506

Description & Particulate Matter in Injection

CDSCO, East Zone

CDL,

Kolkata

37

Levosalbutamol Syrup 1mg / 5ml

2027 0623

06/2023

05/2025

Greenco Biologicals Pvt. Ltd., Krishnapur, P.O. Madanpur, Krishnapur,

P.S. Madhyamgram, Distt. North 24 Parganas,

Kolkata 700128.

Description & pH

CDSCO, East Zone

CDL,

Kolkata

38

Glycerin IP 98% w/w

0453

11/2022

10/2024

Saar Biotech Pvt. Ltd., VPO Bhud, Tehsil Baddi, Distt. Solan (H.P.) 173205.

Water & Assay of Glycerin

CDSCO, East Zone

CDL,

Kolkata

39

Pyrazinamide Tablets IP 500 mg, (Pyrazinamide-

500)

T-5674

12/2022

11/2024

Jackson Laboratories Pvt. Ltd., 22-24, Majitha Road, Bye Pass, Amritsar 143001 (India).

Description & Dissolution

CDSCO, East Zone

CDL,

Kolkata


40

Ursodeoxycholic Acid Tablets IP (Mascholic- 300)

MT223471

07/2022

06/2024

Mascot Health Series Pvt. Ltd., Plot No. 79, 80, Sec- 6A, IIE, Sidcul, Haridwar- 249403, Uttarakhand, India.

Description

CDSCO, East Zone

CDL,

Kolkata

41

Ambroxol Hydrochloride Solution

100 ml

AML3035

07/2023

06/2025

Caplet India Pvt. Ltd., Rekjuani, Kolkata-700135.

Description

CDSCO, East Zone

CDL,

Kolkata

42

Pheniolic Disinfecting Multipurpose Surface Cleaner cum Deodriser (Lemenol)

Not mentioned

Not mentioned

Not mentioned

Pragati Udyog, Rudhiya Mesra, Ranchi-15

Classification, Gradation, Germicidal value (RW Coefficient) & Labelling

State FDA, Ranchi-VII, Jharkhand

CDL,

Kolkata

43

Pheniolic Disinfecting Multipurpose Surface Cleaner cum Deodriser (Lytner)

Not mentioned

Not mentioned

Not mentioned

Pragati Udyog, Rudhiya Mesra, Ranchi-15

Gradation, Germicidal value (RW Coefficient) & Labelling

State FDA, Ranchi-VII, Jharkhand

CDL,

Kolkata

44

Pheniolic Disinfecting Multipurpose Surface Cleaner cum Deodriser (Cleaner)

B 20

Not mentioned

Not mentioned

Pragati Udyog, Rudhiya Mesra, Ranchi-15

Gradation, Germicidal value (RW Coefficient) & Labelling

State FDA, Ranchi-VII, Jharkhand

CDL,

Kolkata

45

Disinfecting Multipurpose Surface Cleaner cum Deodriser (Nemonol Premium)

Not mentioned

Not mentioned

Not mentioned

Pragati Udyog, Rudhiya Mesra, Ranchi-15

Classification, Gradation, Type, Stability after Dilution, Germicidal value

(RW Coefficient) & Labelling

State FDA, Ranchi-VII, Jharkhand

CDL,

Kolkata

46

Phenolyne Disinfectant Fluid Phenolic Type (Phenolyne)

Not mentioned

Not mentioned

Not mentioned

Pragati Udyog, Rudhiya Mesra, Ranchi-15

Labelling

State FDA, Ranchi, Jharkhand

CDL,

Kolkata


47

Phenolyne Disinfectant Fluid Phenolic Type (Phenolyne)

A

Not mentioned

Not mentioned

B.R.S. Chemical Works, 39, Harish Chatterjee St. Kolkata- 700026.

Gradation, Germicidal value (RW Coefficient) & Labelling

State FDA, Ranchi, Jharkhand

CDL,

Kolkata

48

Paracetamol Tablets I.P. 500 Mg.

GT2G030

Jul-2022

Jun-2025

Scott-Edil Pharmacia Ltd., 56, EPIP, Phase-I,

Jharmajri, Baddi, Dist.

Solan-173205(H.P.) INDIA

Dissolution

State FDA , Assam

RDTL,

Guwahati

49

GLIMEPIRIDE TABLETS I.P. (2 mg.)

MT224871

Oct-2022

Sep-2024

Mascot Health Series Private. Limited., Plot No. 79, 80, Sector-6A, IIE,

SIDCUL, Haridwar- 249403

Description

State FDA , Assam

RDTL,

Guwahati

50

AMLODIPINE BESYLATE TABLETS

I.P. 5 mg. (AMLOMART-5 mg TABLETS)

PT-31011

Apr-2023

Mar-2025

Pharmaroots Healthcare, Khasra No. 411, Village Tipra, P.O. Barotiwala, Tehsil Baddi, Distt. Solan,

H.P.

Assay of Amlodipine

State FDA, Arunachal Pradesh

RDTL,

Guwahati

51

Etizolam Tablets (0.5 mg)

2268

Nov-2022

Oct-2024

RELIANCE Formulation Pvt. Ltd., 7/2-A, G.I.D.C.

Estate, Phase-I, Vatva, Ahmedabad - 382 445.

content of Etizolam (assay)

CDSCO Sub

Zone, Guwahati

RDTL,

Guwahati

52

PANTOPRAZOLE TABLETS I.P. (40 mg)

PAA-504

Jan-2023

Dec-2024

Healers Lab, Unit-II, Plot No. 33, HPSIDC Extn.,

Baddi, Dist. -Solan, H.P.

Dissolution in Acid Stage & Description

State FDA, Assam

RDTL,

Guwahati

53

Methylcobalamin, Pyridoxine Hcl, Nicotinamide & D Panthenol Injection (NEUROSIN PLUS),

2ml.

H30051

Aug-2023

Jan-2025

Arion Healthcare, Vill. Kishanpura, Baddi, Distt. Solan-174101 (H.P.)

Identification and Assay of D- Panthenol

CDSCO SUB- ZONE, BADDI

RDTL,

Guwahati

54

Ramipril Tablets I.P. 5 mg.

RMFT1001

Jun-2022

May-2024

Unicure India Ltd,, C-21, 22 & 23, Sector-3, Noida-

201 301, Distt. Gautam Budh Nagar (U.P.).

content of Ramipril (Assay)

State FDA, Patna, Bihar

RDTL,

Guwahati


55

ALBENDAZOLE TABLETS I.P.

MS4AI2301

Jan-2023

Dec-2025

MAXTAR BIO-GENICS,

Khasra No. 705, Vill. Malku Majra, Nalagarh

Road, Baddi, Distt. Solan- 173205 (H.P.)- India

Dissolution

CDSCO Sub

Zone, Guwahati

RDTL,

Guwahati

56

Ibuprofen and Paracetamol Tablets I.P. (400 mg/325 mg)

GT1153

Jun-2022

May-2024

OMEGA PHARMA,

Khasra No.-482, Village- Saliyar, Roorkee-247667, Distt.- Haridwar,

(Uttarakhand)

Dissolution of Ibuprofen and Paracetamol

State FDA, Jharkhand

RDTL,

Guwahati

57

SUCRALFATE & OXETACAINE SUSPENSION 1 gm + 10 mg (RANPURE SUSPENSION)

AL23-0108

Feb-2023

Jan-2025

ASPO PHARMACEUTICALS LLP, Plot No.10,

HIMUDA Industrial Area, Phase-IV, Bhatoli Kalan, Baddi, Distt. Solan (H.P.) - 173205

pH and Assay Content of Oxetacine

CDSCO Zonal Office, Hyderabad

CDTL,

Hyderabad.

58

SORBITAL 70 % IP

GAIL/IP/509

Jul-2023

Jun-2028

GOYA AGRO INDUSTRIES LIMITED, DML NO-1080-OSP (H)

Factory : Vill. Khanpur Kollan Kurukshetra - 136131

Test for Ethylene Glycol

CDSCO Zonal Office, Baddi

CDTL,

Hyderabad.

59

SPIRONOLACTONE TABLETS IP 25 mg (ALDACTONE)

02A22020

Nov-2022

Oct-2025

RPG LIFE SCIENCES LIMITED, 3102/A,

G.I.D.C., Estate, Ankleshwar-393 002, Dist. Bharuch, Gujarat, India.

Dissolution

CDSCO Zonal Office, Hyderabad

CDTL,

Hyderabad.

Also Read:Drug alert: CDSCO flags 62 drug samples

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