Drug Alert: 70 Drug Samples Fail To Clear CDSCO Test, 1 Declared spurious

Written By :  Dr. Divya Colin
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-04-23 12:30 GMT   |   Update On 2025-04-23 12:30 GMT
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New Delhi: With an aim to make stakeholders aware of the not-of-standard-quality (NSQ) batches identified in the market, in its latest drug alert, the apex drug regulatory body, the Central Drug Standard Control Organization (CDSCO), has flagged 70 medicine batches for failing to qualify for a random drug sample test and declared Telma 40 (Telmisartan tab 40mg) batch no. 5240226 as spurious for the month of March 2025.

This came as part of the continuous regulatory surveillance, where drug samples are picked from sales/distribution points, analyzed, and a list of spurious drugs is displayed on the CDSCO portal on a monthly basis. The purpose of displaying the spurious drugs list is to make stakeholders aware of the spurious drug batches identified in the market.

These include compound Amoxicillin Sodium and Clavulanate Potassium manufactured by Shandong New Time Pharmaceuticals, Pantoprazole Gastro- Resistant Tablets (Pantoshang-40) manufactured by Shangrila Industries, Pantoprazole tablets manufactured by Hindustan Antibiotics, Adrenaline Bitartrate Injection manufactured by Rathi Laboratories, Bupivacaine Hydrochloride In Dextrose Injection manufactured by Aishwarya Healthcare, Montelukast and Levocetirizine Tablet (Dumont-L ) manufactured by Hygeia Pharmaceuticals, Nitrazepam Tablets manufactured by Anglo-French Drugs and Industries, and others.

In addition, the apex drug regulatory body has released the list of spurious drugs for the month of March,2025, mentioning that Telma 40 (Telmisartan 40mg) with batch no. 5240226 failed critical quality tests and was declared as spurious. Manufactured in Feb 2024 with an expiry date of January 2027, this product does not conform to Indian Pharmacopoeia (IP).

As per the alert, the actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug.

Furthermore, in accordance with the alert, a drug shall be deemed to be spurious;

a. If it is manufactured under a name which belongs to another drug; or
b. if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or
c. If the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or
d. If it has been substituted wholly or in part by another drug or substance; or
e. If it purports to be the product of a manufacturer of whom it is not truly a product.
The term “Spurious Drug” has been defined under Section 17-B of the Drugs and Cosmetics Act, 1940.

List of Drugs, Medical Devices, Vaccine and Cosmetics declared as Spurious for the Month of March- 2025

S.No.

Name of

Drugs/medical device/cosmetics

Batch No.

Date of

Manufacture

Date of Expiry

Manufactured By

Reason for failure

Drawn By

Firm’s reply

Remarks

1.

Telma 40 (Telmisartan Tab I.P. 40mg)

5240226

Feb-24

Jan-27

Under Investigation

Does not Conform to I.P.

-

The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug.

The product is purported to be spurious, however, the same is subject to outcome of investigation.

Meanwhile, drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs. The term ‘standards of quality’ is defined under Section 16 (1) (a) of the Drugs and Cosmetics Act, 1940, as ‘standards of quality’ meaning that the drug complies with the standards set out in the Second Schedule of the said Act.
A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of pH, particulate matter, description, etc.
The samples collected were tested in six laboratories CDL Kolkata, RDTL Guwahati, CDTL Mumbai, and RDTL Chandigarh.

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

S.No

Product/Drug Name

Batch No.

Manufacturing Date

Expiry Date

Manufactured By

NSQ Result

Reported by CDSCO

Laboratory

1.

Amoxicillin Sodium and Clavulanate Potassium (Sterile) 5:1

4032409004

09/2024

08/2028

M/s. Shandong New Time Pharmaceuticals Co. Ltd., No.1, North Outer Ring Road, Feixian Country, Shandong

Province, China

Particulate Matter

CDL, Kolkata

2.

Pantoprazole Gastro- Resistant Tablets IP

(Pantoshang-40)

SP240165

06/2024

05/2026

M/s. Shangrila Industries (P) Ltd., (Pharma Division) Mining

Rangpo East Sikkim-737132

Dissolution (Buffer Stage)

CDL, Kolkata

3.

Pantoprazole tablets IP 40 mg

0081

05/2024

04/2026

M/s. Hindustan Antibiotics Ltd., Pimpri, Pune-411018, INDIA

Dissolution (Buffer Stage)

CDL, Kolkata

4.

Adrenaline Bitartrate Injection IP (Reoline Injection)

AD-204

11/2024

04/2026

M/s. Rathi Laboratories (Hindustan) Pvt. Ltd., Industrial Area, Patna-800013 Bihar

Appearance of solution,

Particulate matter and Description

CDL, Kolkata

5.

Bupivacaine Hydrochloride In Dextrose Injection USP

AA4009

03/2024

02/2026

M/s. Aishwarya Healthcare, Samardung, Kower Kabrey Block, South Sikkim-737137

Particulate matter (visible) and Description

CDL, Kolkata

6.

Montelukast and Levocetirizine Tablet (Dumont-L )

DML 062

12/2024

11/2027

M/s.Hygeia Pharmaceuticals Mfg (P) Ltd., 608, Dwarir Road, Dhamaitala, P.O.-

Dakshin Jagaddal, Dist-24 Pgs(S), Pin-700151, W.B.

Dissolution of Levocetirizine Hydrochloride and Montelukast

CDL, Kolkata

7.

Nitrazepam Tablets I.P. 10 mg. (Nitravet-10)

AXI23003P

09/2023

02/2028

M/s. Anglo-French Drugs & Industries Limited, Plot No-4, Phase-II, Peenya Industrial

Area, Peenya, Bengaluru-560 058

Spurious Identification and Assay of Nitrazepam

CDL, Kolkata

8.

Vitamin B1, Vitamin B2, Nicotinamide, Vitamin B6, Vitamin B12 & Calcium D-Pantothenate Syrup (B-Complex

Syrup)

BOB-2440

06/2024

11/2025

M/s. Apple formulations Pvt. Ltd., Plot no. 208, Kishanpur, Roorkee-247667 (U.K.)

Assay of Vitamin B12

CDL, Kolkata

9.

Vitamin B1, Vitamin B2,

Nicotinamide, Vitamin B6, Vitamin B12 &

BOB-2451

06/2024

11/2025

M/s. Apple Formulations Pvt.

Ltd., Plot no. 208, Kishanpur, Roorkee-247667 (U.K.)

Total aerobic viable count

CDL, Kolkata

Calcium D-Pantothenate Syrup (B-Complex Syrup)

under Microbial limit test

10.

Vitamin C, Vitamin B12, Folic Acid and Niacinamide Injection (Curevit-12 (Combi Pack

))

CP-937

12/2024

05/2026

M/s. Pharma Cure Laboratories, Garha Jalandhar 144022 Punjab

Particulate Matter and Description

CDL, Kolkata

11.

Ceftriaxone and Salbactam for Injection

1.5 g (TriaxS 1.5 g)

DC40117

09/2024

08/2027

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

Mauja, Jharmajri, Baddi, Dist. Solan (H.P.)-173205

Particulate Matter and Description

CDL, Kolkata

12.

Ceftriaxone & Sulbactam for Injection IP (Cefamed-S)

B4CT05E

10/2024

09/2026

M/s. Lenus Lifecare Pvt. Ltd., Plot No. 1, Industrial Area,

Chambaghat, Solan (H.P.)-173 213(India)

Clarity of Solution,

Particulate matter and Description

CDL, Kolkata

13.

Pantoprazole Gastro- Resistant and Domperidone Prolonged-release

Capsules IP (Pantoryl- DSR )

MC-24229

04/2024

03/2026

M/s. Matins Healthcare Pvt. Ltd., Plot No.-10, Sector-5, I.I.E., SIDCUL, HARIDWAR- 249403 (U.K.)

Dissolution of Pantoprazole Sodium in Buffer stage

CDL, Kolkata

14.

Chlorhexidine Gluconate & Ethyle Alcohol Baed Hand and Skin Disinfectant (Safiser

Hand Rub)

IJWX/074

09/2023

09/2025

M/s. SS Enterprises F-76,, Sector-8, Noida, G.B. Nagar (U.P.), India 201301

Assay of Ethyl alcohol, Chlorhexidine Gluconate

CDL, Kolkata

15.

Dexamethasone Sodium Phosphate Injection IP (Dexagain Injection )

VHI274001

12/2024

11/2026

M/s.Vidit Healthcare, Village Kishanpura, Paonta Sahib, Distt-Sirmour, H.P.-173025

Assay of Dexamethasone Sodium Phosphate calculated as Dexamethasone

Phosphate

CDL, Kolkata

16.

Itraconazole Capsules BP 100 mg (Fungis-100)

C4050

06/2024

05/2026

M/s. Merril Pharma Pvt. Ltd., Unit- II Plot No.24,25,31,32

Somnath Industrial Park, Kerala GIDC, Near Bavla, Ahmedabad -382220, Gujarat, India

Dissolution

CDL, Kolkata

17.

Gentamicin Sulphate

Injection IP (GENTAMICIN )

GN-37

09/2024

08/2026

M/s. Amba research

Laboratories, Road No.-21, Rajiv Nagar, Patna-24

Sterility,

Particulate Matter and Description

CDL, Kolkata

18.

Methylcobalamin, Thiamine HCl, Pyridoxine HCl, D-

UGA-24436E

08/2024

01/2026

M/s. Ultra Drugs Pvt. Ltd., Plot No. 1315-1318, Manpura,

Particulate Matter and Assay of Methylcobalamin

CDL, Kolkata

Panthenol and Nicotinamide Injection (Nuropat)

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

19.

Chloramphenirol Eye Ointment I.P. 1% W/W (EXPHENICOL)

1624-366

01/07/2024

30/06/2026

M/s. Zee Laboratories Ltd., Behind 47, Industrial Area, Paonta Sahib-173025

Assay of Chloramphenicol

CDL, Kolkata

20.

Calcium& Vitamin D3 Tablets IP

QT23144

11/2024

10/2026

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

Description, Dissolution (for Calcium) and Assay of

Elemental Calcium

CDL, Kolkata

21.

Rabeprazole Sodium Injection I.P.

MD23H29

08/2023

07/2025

M/s. Martin and Brown Bio- sciences, K.No.-918/419, Malkumajra, Nalagarh Road, Baddi, Distt.-Solan (H.P.) - 173205

Particulate matter, Related Substances, Clarity of solution, pH, Assay of Rabeprazole

Sodium and Description

CDL, Kolkata

22.

Rabeprazole Sodium Injection I.P.

MD23H27

08/2023

07/2025

M/s. Martin and Brown Bio- sciences, K.No.-918/419, Malkumajra, Nalagarh Road, Baddi, Distt.-Solan (H.P.) - 173205

Clarity of solution, Particulate matter, Related Substances, pH, Assay of Rabeprazole

Sodium and Description

CDL, Kolkata

23.

Iron Sucrose Injection USP

MA24G46

07/2024

06/2026

M/s. Martin and Brown Bio- sciences Pvt. Ltd., K.No.- 918/419, Malkumajra, Nalagarh Road, Baddi, Distt.- Solan (H.P.) -173205

pH

CDL, Kolkata

24.

Cholecalciferol (Vitamin D3) 60000 IU/gm

Granule Sachet

TPD24015

07/2024

06/2026

M/s. Affy Parenterals, Vill. Gullarwala, P.O. Baddi, Distt.

Solan -173205 (HP)

Assay/content of Cholecalciferol

(Vitamin D3)

CDL, Kolkata

25.

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

GTL1258

12/2024

11/2026

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

Kharedi, Dahod-389151, Gujarat.

Dissolution (for Calcium)

CDL, Kolkata

26.

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

500 )

GTL1296

12/2024

11/2026

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

Kharedi, Dahod-389151, Gujarat.

Dissolution (for Calcium)

CDL, Kolkata

27.

Omeprazole for Injection (Lyophilized) 40 mg (Fexona )

324-609

05/2024

04/2027

M/s. Zee Laboratories Ltd., Behind 47, Industrial Area, Paonta Sahib-173025

Sterility of Water for Injection

CDL, Kolkata

28.

Omeprazole for Injection (Lyophilized) 40 mg (Fexona )

324-608

05/2024

04/2027

M/s. Zee Laboratories Ltd., Behind 47, Industrial Area, Paonta Sahib-173025

Sterility of Water for Injection

CDL, Kolkata

29.

Cholecalciferol (Vitamin D3) 60000 IU/gm

Granule Sachet

TPD24020

07/2024

06/2026

M/s. Affy Parenterals, (WHO- CGMP/ISO 9001:2015

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

Assay/content of Cholecalciferol (Vitamin D3)

CDL, Kolkata

30.

Cholecalciferol (Vitamin D3 ) 60000 IU/gm

Granule Sachet

TPD24019

07/2024

06/2026

M/s. Affy Parenterals, (WHO- CGMP/ISO 9001:2015

Certified Co.) Vill-Gullerwala, PO-Baddi, Dist-Solan-173205

(H.P.)

Assay/content of Cholecalciferol (Vitamin D3)

CDL, Kolkata

31.

Cholecalciferol (Vitamin D3 ) 60000 IU/gm

Granule Sachet

TPD24018

07/2024

06/2026

M/s. Affy Parenterals, (WHO- CGMP/ISO 9001:2015

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

Assay/content of Cholecalciferol (Vitamin D3)

CDL, Kolkata

32.

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

500 )

GTL1288

12/2024

11/2026

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

Gujarat

Dissolution (for Calcium)

CDL, Kolkata

33.

Cefuroxime Axetil Tablets I.P. 500 mg (BREXETIL-500 )

ST-25345

10/2024

09/2026

M/s. Sunvij Drugs Private Limited, 511, GIDC, Waghodia, Baroda-391760, Gujarat

Dissolution

CDL, Kolkata

34.

Aceclofenac & Paracetamol Tablets (ALDIGESIC P )

BHT23229M B

09/2023

08/2025

M/s. Sri Ram Healthcare Pvt. Ltd., Plot No.-81-C/2, EPIP,

Phase-1, Jharmajri, Baddi, Dist-Solan (H.P.)-174103

Description

CDL, Kolkata

35.

Ambroxol Hydrochloride and N-Acetyl L-Cysteine Tablets (Kufril-NT )

INT 115

07/2024

06/2026

M/s. Med Manor Organics Pvt Ltd., Unit-II, Kh.No-143 M/7, Village-Raipur, Pargana- Bhagwanpur, Tehsil-Roorkee,

Dist. Haridwar, Uttarakhand- 247661

Description

CDL, Kolkata

36.

Calcium Gluconate Injection I.P. 10 ml

MV24B35

02/2024

01/2026

M/s. Martin and Brown Bio- sciences Pvt. Ltd., K.No.- 918/419, Malkumajra,

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

Extractable Volume, Particulate matter and Description

CDL, Kolkata

37.

Tranexamic Acid Injection I.P. (Tranexacure Injection )

TC-038

12/2024

11/2026

M/s. Pharma Cure Laboratories, Garha Jalandhar 144022 Punjab

Particulate Matter and Description

CDL, Kolkata

38.

Domperidone Suspension IP

DPS3-24- 225

08/2024

07/2026

M/s. Ornate Labs Pvt. Ltd., Bela Industrial Estate, Muzaffarpur-842005

Total aerobic viable count under Microbial contamination test and Assay/content of

Domperidone

CDL, Kolkata

39.

Calcium Carbonate 500 mg + VIT.D3 250 IU

TABLETS IP (CALXIA- 500 )

GTL1307

12/2024

11/2026

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

Kharedi, Dahod-389151, Gujarat

Dissolution (for Calcium)

CDL, Kolkata

40.

Calcium CarbonateE 500 mg + VIT. D3 250 IU TABLETS IP (CALXIA-500 )

GTL1312

12/2024

11/2026

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

Kharedi, Dahod-389151, Gujarat

Dissolution (for Calcium)

CDL, Kolkata

41.

Calcium Carbonate 500 mg + VIT. D3 250 IU

TABLETS IP (CALXIA- 500 )

GTL1313

12/2024

11/2026

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

Kharedi, Dahod-389151, Gujarat

Dissolution (for Calcium)

CDL, Kolkata

42.

Calcium Carbonate 500 mg.+VIT. D3 250IU TABLETS IP (CALXIA-

500 )

GTL1314

12/2024

11/2026

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

Kharedi, Dahod-389151, Gujarat

Dissolution (for Calcium)

CDL, Kolkata

43.

Calcium Carbonate 500 mg.+VIT. D3 250 IU

TABLETS IP (CALXIA- 500 )

GTL1315

12/2024

11/2026

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

Kharedi, Dahod-389151, Gujarat

Dissolution (for Calcium)

CDL, Kolkata

44.

Iron Sucrose Injection USP 100 mg/5ml

24RS13

10/2024

09/2026

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

Alkalinity and pH

CDL, Kolkata

45.

Iron Sucrose Injection USP 20 mg/ml (I-PIC)

A24105K

06/2024

05/2026

M/s. Pace Biotech Village

Surajpur, Paonta Sahib, Dist. Sirmour (H.P.)-173001

Particulate matter in Injections

CDL, Kolkata

46.

Gentamicin Sulphate Injection I.P. 30 ml (Gentalab )

OGNI-037

07/2024

06/2026

M/s. Laborate Pharmaceuticals India Ltd., #31, Rajban Road, Nariwala Paonta Sahib, (H.P.)

Particulate matter and Description

CDL, Kolkata

47.

Alprazolam Tablets I.P.

0.50 mg (Calmpik-05)

AT24266

07/2024

06/2027

M/s. Aarpik Pharmaceuticals Pvt.Ltd., C1/306/5,Kerala G. I.D.C,Kerala Bavla Road,Dist. Ahmedabad

Dissolution

RDTL, Guwahati

48.

Calcium 500 mg with Vitamin D3 250 IU Tablets IP

LMT240449

04/2024

03/2026

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

Haridwar249403 (U.K)

Dissolution (Calcium) and Assay of Vitamin

D3

RDTL, Guwahati

49.

Calcium And Vitamin D3 Tablets IP

07493

01/2024

12/2025

M/s. Healthy Life Pharma Pvt. Ltd., Factory: N-31/1, M.I.D.C.,

Tarapur, Boisar - 401 506, Dist. Palghar. Maharashtra

Assay/Content of Vitamin D3

RDTL, Guwahati

50.

Pantoprazole Gastro- Resistant Tablets IP 40 mg (Pantojack-40)

T-1261

04/2024

03/2026

M/s. Jackson Laboratories Pvt.Ltd, 22-24, Majitha Road, Bye Pass, Amritsar-143 001(India)

Description and Dissolution

RDTL, Guwahati

51.

Telmisartan Tablets I.P. (DV-TELMI-40)

GTE2206

08/2024

07/2026

M/s. Digital Vision, 176, Mauza

Ogli, Nahan Road, Kala-Amb, Distt. Sirmour (H.P.) - 173 030

Dissolution

RDTL, Guwahati

52.

Telmisartan Tablets IP 40mg

251TTF014

08/2024

07/2026

M/s. Swiss Garnier Life Sciences, No. 21-23, Industrial Area, Mehatpur, Dist. Una, Himachal Pradesh-174 315.

INDIA

Dissolution

RDTL, Guwahati

53.

Dexamethasone Oral Solution USP 0.5mg per 5ml

LG24-29

07/2024

06/2026

M/s. Om Biomedic Pvt. Ltd..,, Plot No. 68, 69, 82 & 83, Sector - 6A, IIE, SIDCUL,

Haridwar-249 403 (U.K.)

Assay

RDTL, Guwahati

54.

Amoxycillin & Potassium Clavulanate Injection IP.

AB193049A

05/2023

04/2025

M/s. ANG Lifesciences India Ltd., Village: Kishanpura, Nalagarh Road, Tehsil: Baddi, Distt.: Solan, HP-174101

Assay (Content of Clavulanic Acid)

RDTL, Guwahati

55.

Insulin Syringe (U-40 Insulin 1ml Syringe) (Mr. INJECT)

0123338

12/2023

11/2028

M/s Biomed Healthcare Products Pvt. Ltd.,, Unit-II, Plot No. 62-65, Sector-6A, Sidcul,

Haridwar 249403, Uttarakhand, India

Sterility

RDTL, Guwahati

56.

Infusion Set (BMD)

BIV-020

08/2024

07/2027

M/s.Bhagwati Medicare devices, 8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.- Ramol Road,

Amraiwadi, Ahmedabad- 380026. Gujarat (India)

Sterility

RDTL, Guwahati

57.

Amoxycillin & Potasium Clavulanate Tablets I.P. (IPHA CLAV-375)

NCP-151

01/2024

06/2025

M/s. Park Pharmaceuticals, Vill. Kalujhanda, Near Nanakpur, Teh. Baddi, Distt. Solan (H.P.)- 174103

Assay of Clavulanic Acid

RDTL, Guwahati

58.

Lactulose Solution

U.S.P. (Apelact), 200 ml

AFL-121

08/2024

07/2026

M/s.Apex Formulations Pvt. Ltd., 1276, Raipur, Highway,

Dist. Mehsana, Gujarat

"Organic impurities" and

CDTL-Mumbai

"Assay of Lactulose"

59.

Lactulose Solution

U.S.P. (Reevac), 100 ml

R23K015

11/2023

10/2025

M/s.Rhombus Pharma Private Limited., 816/1, Rakanpur, Kalol- 382721 (Gujarat)

"Organic impurities"

CDTL-Mumbai

60.

Albendazole Tablets I.P. (DV-BEND 400)

GTE1974

07/2024

06/2026

M/s Digital Vision, 176, Mauza Ogli, Nahan Road, Kala-Amb, Dist. Sirmour (H.P.)- 173 030.

"Dissolution"

CDTL-Mumbai

61.

Atorvastatin Tablets IP (GATOVAS- 20)

CT24250423

06/2024

05/2026

M/s.CMG Biotech Pvt. Ltd., (Unit-II), Plot No.58, Phase-III, Industrial Area, Sansarpur Terrace, HP- 176501. Mkt By :

Same as manufacturer

"Related substances"

CDTL-Mumbai

62.

Atorvastatin Tablets IP 10 mg

00 57

09/2024

08/2026

M/s.Hindustan Antibiotics Ltd., Pimpri, Pune- 411 018, India.

"Related substances"

CDTL-Mumbai

63.

Sodium Bicarbonate Tablets U.S.P. 1000 mg

T-2401309

01/2024

12/2025

M/s.Rivpra Formulation Pvt. Ltd., Plot No.8, Sector-6A, I.I.E., SIDCUL, Haridwar- 249

403 (U.K.). Manufatured for : Pharmaceuticals and Medical Devices Bureau of India (PMBI), 8th Floor, Videocon Tower, Block E-1, Jhandewalan Extension, New

Delhi-110 055.

"Description"

CDTL-Mumbai

64.

Pantoprazole Sodium Gastro-Resistant & Domperidone Prolonged-Release Capsules IP (Pengin- DSR Capsules)

NHD24057D

01/2024

12/2025

M/s.Nest Healthcare Private Limited., Plot No. 300, G.I.D.C., Odhav, Ahmedabad- 382415 (Guj.). India. Mkt By : Megan healthcar, C-403, 4th Floor, Abhishek Complex 1, Opp. Haripura Bus Stop, Babupura, Asarwa,

Ahmedabad, Gujarat.

"Dissolution for Domperidone"

CDTL-Mumbai

65.

Sacubitril and Valsartan Tablets 50 mg (SVJAJ 50)

SVA04H24C

08/2024

07/2026

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

391775, Gujarat, India.

"Assay"/ content of "Sacubitril" and "Valsartan"

CDTL-Mumbai

66.

Sodium Chloride Injection I.P. 0.45 % W/V (0.45 NS)

1266688H

06/2024

05/2027

M/s.Shree KrishnaKeshav Laboratories Ltd., Amraiwadi

Road, Ahmedabad- 380 008, India

Misbranded

CDTL-Mumbai

67.

Hydro Cellular Foam with ART Principle Antibacterial PU top

10241283L

10/2024

09/2027

M/s Datt Mediproducts Pvt. Ltd., 52-54 & 63-64,Roz-ka-

Sterility

RDTL,

Chandigarh

Layer with Silicone Gel (Veflfix-S Border (Sacrum))

Meo Ind. Area, Nuh.Mewat- 122103, Haryana, India

68.

Chlorpheniramine Maleate Dextromethorphan Hydrobromide &

Phenylephrine HCl Syrup (DXCP)

ML-012

08/2024

07/2026

M/s Maha Avtar, Health Care Pvt. Ltd., D-22, Sector-17, Kavi Nagar Indl.Area, GZB-201002.

Identification and Assay of Dextromethorpha n Hydrobromide

RDTL,

Chandigarh

69.

Povidone-Iodine Ointment USP

OI4004A

09/2024

08/2026

M/s. Navkar Lifesciences, Plot No. 76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan (H.P.)

Assay of Povidone Iodine calculated as available Iodine

RDTL,

Chandigarh

70.

Omega-3 Fatty Acid, Green Tea Extract, Ginkgo Biloba, Ginseng Extract, Grape Seed Extract, Multimineral, Multivitamin with Antioxidants and Trace Elements Softgel Capsules (VRICH-24 CAPSULES)

RHSD-3149F

02/2024

01/2026

M/s.Ramom Healthcare Pvt.Ltd. (An ISO & GMP Certified Company), Plot No.58, Sector-5, Parwanoo (HP)

Assay of Magnesium Oxide calculated as elemental Magnesium, Vitamin D3, Ferrous Fumarate, Zinc Oxide calculated as elemental Zinc, Copper Sulphate Pentahydrate calculated as elemental Copper, Manganese Sulphate calculated as elemental Manganese, Calcium Ascorbate, Citrus Bioflavonoids, Vitamin B6, Folic

acid

RDTL,

Chandigarh

Also Read:Drug Alert: CDSCO Flags 52 Formulations As Not Of Standard Quality

To view the official notice, click the link below:
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