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

B. State Laboratories

S.No

Product/Drug Name

Batch No.

Manufacturing Date

Expiry Date

Manufactured By

NSQ Result

Reported by CDSCO

Laboratory

1.

Liquid Paraffin IP

EP4032

01/24

12/26

Repacked by:- Kerala State Drugs and Pharmaceuticals Ltd, Kalavoor. P.O, Alappuzha

It fails the test of light absorption as per IP

Drugs Testing Laboratory Thiruvananthapuram

2.

Losartan Potassium Tablets IP 50 mg

HLOA06

11/23

10/25

Hindustan Antibiotics Ltd, at II, W.E.A.

Faridabad: 121 001(Haryana) R.O,

Pimpri, Pune -411 018

It fails the test ‘Dissolution’ as per IP

Drugs Testing Laboratory Thiruvananthapuram

3.

Amloheart-AT [Amlodipine Besylate and Atenolol Tablets]

LE223030

03/23

02/25

Lividus Pharmaceuticals pvt.Ltd, ikeva, Level2, Agnito Tech park,141 Kandachavadi, Near,

Perungudi, OMR, Chennai-600096

It fails the test ‘Assay’ of Amlodipine Besylate

Drugs Testing Laboratory Thiruvananthapuram

4.

Bacotil-200 [Cefpodoxime Proxetil Tablets USP ]

ZTB-148

03/24

02/26

Zenith Healthcare Ltd works: 388/34, Changodarlnd. Estate, Sarkhej Bavla Highway, Changodar- 382213

(Gujarat)

It fails the test ‘Dissolution’ as per USP

Drugs Testing Laboratory Thiruvananthapuram

5.

Oseltamivir Cap

IP 75 mg

D 0444/24-

25

Supplied by Kerala

Medical Services

The sample does not conform to IP

Drugs Testing

Laboratory

Corporation Ltd, Thycaud P.O, Thiruvananthapuram-14

standard with respect to the ‘Descriptive part’

of hard gelatin capsules

Thiruvananthapuram

6.

Haridrakhandam

207/23

03/24

02/26

Bhaskaravilasam Vaidyasala, Panayamuttom, Nedumangadu Thiruvananthapuram 695

561

It fails the test ‘pH’ as per API

Drugs Testing Laboratory Thiruvananthapuram

7.

Yogarajaguggulu

209/21

03/22

3 yrs from the date of mfg

Bhaskaravilasam Vaidyasala, Panayamuttom, Nedumangadu, Thiruvananthapuram 695

561

It fails the test ‘Alcohol soluble Extractive and pH’ as per API

Drugs Testing Laboratory Thiruvananthapuram

8.

CANDITRAL 100 (ITRACONAZOLE CAPSULE B.P. 100 MG)

5230123

Jan-23

Jun-25

GLENMARK PHARMACEUTICALS LTD.

THE SAMPLE DOES NOT COMPLY WITH B P REQUIREMENTS FOR DISSOLUTION

TEST

Maharashtra

9.

Lytraco 200 Itraconazole Capsules 200 mg

SLP-22445

Feb-23

Jan-25

STERLIFE PHARMA PVT. LTD.

THE SAMPLE DOES NOT COMPLY WITH B P REQUIREMENTS FOR DISSOLUTION TEST THE SAMPLE IS OFFICIAL IN B P

2021 THEREFORE THE SAMPLE IS

Maharashtra

MISBRANDED VIDE SECTION 17(b) AND RULE

96 OF THE DRUGS AND COSMETICS ACT 1940 AND

RULES 1945.

10.

MONTOR -LC TABLET (MONTELUKAST SODIUM & LEVOCETRIZINE DIHYDROCHLORI

DE TABLET I.P.)

B18523001

Jan-23

Dec-24

TORQUE PHARMACEUTICALS PVT. LTD.

THE SAMPLE DOES NOT COMPLY WITH I P REQUIREMENTS FOR DISSOLUTION

TEST

Maharashtra

11.

MONTICET-L

Tablets

( Montelukast & Levocetirizine Hydrochloride Tablets)

TP-7581

Sep-22

Aug-24

TICOMA PHARMACIA

THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR DISSOLUTION TEST FOR MONTELUKAST. THE SAMPLE IS OFFICIAL IN 1 P 2018 THEREFORE THE SAMPLE IS MISBRANDED VIDE SECTION 17(b) AND RULE

96 OF THE DRUGS AND COSMETICS ACT 1940 AND

RULES 1945.

Maharashtra

12.

Levocetrizine Dihydrochloride & Montelukast Sodium Tablets I.P. Zeemont

T22H370C

Aug-22

Jul-24

Bajaj Formulations

THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR

DISSOLUTION

Maharashtra

TEST FOR MONTELUKAST.

13.

VolKast Kid Syrup 60 ml.

ABS- 2301022

Jan-23

Dec-24

Amentis Biotech Pvt. Ltd.

CONTENT OF MONTELUKAST AND LEVOCETIRIZINE GYDROCHLORIDE IN THE SAMPLE IS LESS (i.e.

MONTELUKAST IS 10.50% AND LEVOCETIRIZINE HYDROCHLORIDE IS 71.88% OF THE STATED AMOUNT) THAN THE

PERMISSIBLE LIMITS.

Maharashtra

14.

Levetiracetam Tablets U.S.P.500 Mg

(LEVEEG-500)

T23D050A

Apr-23

Mar-25

BAJAJ FORMULATIONS

THE SAMPLE DOES NOT COMPLY WITH USP REQUIREMENTS FOR

DISSOLUTION.

Maharashtra

15.

M2 Pan-DSR

(Pantoprazole Gastro-resistant & Domperidone Prolonged-release Capsules IP)

CWHC-283

Oct-22

Sep-24

COSWAY PHARMACEUTICALS

THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR DISSOLUTION OF

PANTOPRAZOLE AT ACID STAGE

Maharashtra

16.

Omeford - 40

SNT-220421

Sep-22

Aug-24

SVR HEALTHCARE (A

GMP Certified Company)

THE CONTENT OF OMEPRAZOLE IN THE SAMPLE IS

LESS (l.e. 40.84% OF LABELLED

Maharashtra

AMOUNT) THAN THE SCHEDULE V LIMITS

17.

COZOL-

D(Omeprazole with Domperidone Capsules)

AC1952

Jul-23

Jun-25

ALICON PHARMACEUTICAL PVT LTD

THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR OMEPRAZOLE AND DOMPERIDONE CAPSULES FOR THE DISSOLUTION TEST (OMEPRAZOLE).

THE SAMPLE IS OFFICIAL IN IP.

Maharashtra

18.

DRPLAN-DSR

(Pantoprazole Gasto-resistant & Domperidone Prolonged-release Capsules IP)

AC2209003A

Sep-22

Aug-24

ADDII BIOTECH PVT. LTD.

THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR PANTOPRAZOLE AND DOMPERIDONE CAPSULES FOR THE DISSOLUTION TEST (PANTOPRAZOLE)

.

Maharashtra

19.

SOFTOM-D

Omeprazole and Domperidone Capsules IP

UD2C- 23252B

Apr-23

Mar-25

ULTRA DRUGS PVT. LTD. (UNIT-II)

THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR

OMEPRAZOLE AND

Maharashtra

DOMPERIDONE CAPSULES FOR THE DISSOLUTION

TEST (OMEPRAZOLE).

20.

OMEPRAZOLE & DOMPERIDONE CAPSULES (REMIZOLE-D)

SPC230578 C

Mar-23

Feb-25

SALUS PHARMACEUTICALS

THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR OMEPRAZOLE AND DOMPERIDONE CAPSULES FOR THE DISSOLUTION

TEST (OMEPRAZOLE).

Maharashtra

21.

PANTOPRAZOLE (EC) & DOMPERIDONE (SR) CAPSULES IP

(PANTIAC-DSR)

PTRC-149

Feb-23

Jan-25

IOSIS REMEDIES PVT. LTD.

THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR PANTOPRAZOLE AND DOMPERIDONE CAPSULES FOR THE DISSOLUTION TEST (PANTOPRAZOLE)

.

Maharashtra

22.

DYNACID SUSPENSION

(aluminium, magnesium & simethicone oral

suspension IP.)

BULH23008

Apr-23

Mar-25

Leeford Healthcare Ltd.

1) THE SAMPLE DOES NOT COMPLY WITH I.P. REQUIREMENTS FOR TOTAL

AEROBIC VIABLE

Maharashtra

COUNT IN TEST FOR MICROBIAL CONTAMINATION.

2) TOTAL AEROBIC VIABLE COUNT OF THE SAMPLE IS 20993128 CFU/GM. (1.P. LIMIT-TOTAL AEROBIC VIABLE COUNT OF THE SAMPLE - NOT MORE THAN 100

CFU/GM

23.

ELTHROM-200

(Azithromycin oral suspension IP) 15ML

G-042/5045

May-23

Apr-25

ELFIN DRUGS PVT. LTD.

CONTENT OF AZITHROMYCIN IN THE SAMPLE IS LESS (72.96% OF LABELLED AMOUNT) THAN THE IP LIMIT WITH RESPECT TO ABOVE PROTOCOL. (IP LIMIT-90.0%-

110.0%)

Maharashtra

24.

Alpracan 0.5 Tablets (Alprazolam Tablets)

T2455

Oct-22

Sep-25

Evolet Pharmaceutical Pvt. Ltd.

THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR ALPRAZOLAM TABLETS FOR THE DISSOLUTION TEST WITH RESPECT TO ABOVE

PROTOCOL.

Maharashtra

25.

RABEPP TABLETS

(Rabeprazole Sodium Tablets IP)

ATG2K135

Nov-22

Oct-24

ANROSE PHARMA

CONTENT OF RABEPRAZOLE SODIUM IM THE SAMPLE IS LESS (65.04% OF THE LABELLED AMOUNT) THAN THE IP LIMIT WITH RESPECT TO ABOVE PROTOCOL. (IP LIMIT 90.0% -

110.0%)

Maharashtra

26.

INFI-650 TABLETS (PARACETAMOL TABLETS I.P. 650

mg)

AT-100008

Dec-22

Nov-25

ABARIS HEALTHCARE

THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR DISSOLUTION

TEST.

Maharashtra

27.

CUCID-DM

CDMC501

May-23

Apr-25

TULBROS FORMULATIONS

THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR DISSOLUTION TEST FOR

OMEPRAZOLE IN ACID STAGE.

Maharashtra

28.

Virpan-40

T-2306031A

Jun-23

May-25

WHITE ENGLE LABORATORIES

THE SAMPLE DOES NOT COMPLY WITH IP REQUIREMENTS FOR DISSOLUTION IN

BUFFER STAGE.

Maharashtra

29.

Pantakos-40 (Pantoprazole

CCT231092 B

Sep-23

Aug-25

Cent Cure Pvt Ltd.

THE SAMPLE DOES NOT

Maharashtra