Drug alert: CDSCO flags 41 medicine batches as not of standard quality

New Delhi: In its latest drug safety alert, the apex drug regulatory body, Central Drugs Standard Control Organization (CDSCO) has flagged 41 medicine batches for failing to qualify for a random drug sample test for the month of May.

These drugs samples which are declared not of standard quality include Dr. Reddys Laboratories’ Omeprazole (Delayed- Release) and Domperidone (SustainedRelease) Capsules, Cadila Pharmaceuticals’ CALNIF RETARD (Nifedipine Prolonged Release Tablets I.P. 20 mg), Troikaa Pharmaceuticals’ DYNAPAR AQ (Diclofenac Sodium Injection I.P. 75 mg/ml) and others.

The list further includes Synokem pharmaceuticals’ Rosuvastatin Calcium Tablets IP 10mg, Symbiosis Pharmaceuticals’ Methylcobalamin, Alpha Lipoic Acid, Pyridoxine HCI and Folic Acid Capsules (VEMIFOL PLUS CAPSULES).

This came after analysis and test were conducted by the CDSCO, Drugs Control Departments on 1233 samples. Out of this, 1192 samples were found of standard quality while 41 of them were declared as Not of Standard Quality (NSQ).

A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of disintegration test, failure of moisture content test failure of the sterility test.

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

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of May – 2022.

S.No.

Name of Drugs/medical device/cosmetics

Batch No./Date of Manufacture/Date of Expiry/Manufactured

By

Reason for failure

Drawn By

From

1.

Zinc Sulphate Dispersible Tablets I.P.

B. No.: ZST21050 Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. La- Chemico Pvt. Ltd., Taki Road, Kadambagachi, Barasat, North 24

Parganas , Kolkata –

700125, West Bengal.

Uniformity of Dispersion &

Disintegration

CDSCO

East Zone Kolkata

CDL

Kolkata

2.

Zinc Sulphate Dispersible Tablets I.P.

B. No.: ZST21048 Mfg dt: 10/2021 Exp dt: 09/2023 Mfd by: M/s. La- Chemico Pvt. Ltd., Taki Road, Kadambagachi, Barasat, North 24

Parganas , Kolkata –

700125, West Bengal.

Uniformity of Dispersion &

Disintegration

CDSCO

East Zone Kolkata

CDL

Kolkata

3.

Metfovan -500 SR Tablets (Metformin Hydrochloride (SR) Tablets)

B. No.: APT/04215

Mfg dt: 03/2021 Exp dt: 02/2023 Mfd by: M/s. Amkon

Pharmaceuticals, Plot No. 242, Ind. Area, Phase-IX, S.A.S.

Nagar, Mohali – 160 062, Punjab.

Dissolution &

Assay

CDSCO

East Zone Kolkata

CDL

Kolkata

4.

Acebrophylline Capsules 100 mg

B. No.: PF8AA04 Mfg dt: 11/2020 Exp dt: 10/2022 Mfd by: M/s. Pure &

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

SIDCUL, Ranipur,

Haridwar-249403, Uttarakhand.

Water Content

CDSCO

East Zone Kolkata

CDL

Kolkata

5.

Geragen – 2 ml (Gentamicin Injection IP)

B. No.: V2111674

Mfg dt: 08/2021 Exp dt: 07/2023 Mfd by: M/s. B.M.

Pharmaceuticals, 47- 48, Ind. Area, Phase II, Chandigarh –

160002.

Description &

Particulate Matter

CDSCO

East Zone Kolkata

CDL

Kolkata

6.

DYNAPAR AQ

(Diclofenac Sodium Injection I.P. 75 mg/ml)

B. No.: D23S363

Mfg dt: 11/2021 Exp dt: 10/2023

Mfd by: M/s. Troikaa Pharmaceuticals Ltd., At: Survey No: 46/1-4, Kadaiya Village, Nani

Daman-396210.

Sterility

CDSCO

East Zone Kolkata

CDL

Kolkata

7.

(Afedol- SP) Aceclofenac, Paracetamol & Serratiopeptidase Tablets

B. No.: PBT-238 Mfg dt: 06/2021 Exp dt: 05/2023 Mfd by: M/s. Bonn Schtering Bio

Sciences, Plot No. 64 & 65, 1st Floor, Electronic Park, Thirubuvanai, Mannadipet Commune,

Puducherry 605 107.

Identification & Assay of Serratiopeptidase

CDSCO,

South Zone Chennai

CDL

Kolkata

8.

Agrophylline – 2ml (Etophylline & Theophyline for Injection)

B. No.: AGP-20 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s. Agron Remedies Pvt. Ltd.

Sarverkhera ,

Description &

Particulate Matter

CDSCO

South Zone Chennai

CDL

Kolkata

Moradabad Road,

Kashipur -244713, Uttarakhand.

9.

SPYCLAV 625 LB

(Amoxycillin and Potassium Clavulanate with Lactic Acid Bacillus Tablets)

B. No.: TACLB1011A Mfg dt: 03/2021

Exp dt: 08/2022 Mfd by: M/s.

Associated Biotech, Kishanpura, Guru Majra Road, Baddi, Teh. Nalagarh, Distt. Solan, Himachal

Pradesh – 174101.

Assay

CDSCO

South Zone Chennai

CDL

Kolkata

10.

Metsodoz – 8 Tablets (Methylprednisolone Tablets IP 8 mg)

B. No.: GFM622101

Mfg dt: 07/2021 Exp dt: 06/2023 Mfd by: M/s.

Progressive Lifesciences Pvt. Ltd., Latherdevahoon, P.O. Jhabrera, Roorkee, Distt. Haridwar -247

665, Uttarakhand.

Identification &

Assay

CDSCO

South Zone Chennai

CDL

Kolkata

11.

CALNIF RETARD

B. No.: JKEG21006

Dissolution

CDSCO

CDL

(Nifedipine

Mfg dt: 07/2021

Ahmedabad

Kolkata

Prolonged Release

Exp dt: 06/2024

Tablets I.P. 20 mg)

Mfd by: M/s. Cadila

Pharmaceuticals

Limited, Industrial

Growth Centre,

SIDCO, Samba-184

121, Jammu &

Kashmir.

12

Saccharomyces

B. No.: SBC/C/002

Moisture Content

CDSCO

CDL

boulardii Capsules

Mfg dt: 09/2021

Hyderabad

Kolkata

(250 mg)

Exp dt: 08/2023

Mfd by: M/s. Unique

Biotech Limited, Plot

No.-2, Phase- II, MN

Park, Kolthur Village,

Shameerpet Mandal,

Medchal Malkajgiri

District, Hyderabad –

560 078, Telangana,

India.

13.

Enoxaparin Sodium Injection I.P.

60mg/0.6ml

B. No.: SENXB2118 Mfg dt: 12/2021 Exp dt: 11/2023

Mfd by: M/s. Samarth Lifescience Pvt. Ltd., Unit – II, Plot No. 2, Industrial Area, Lodhimajra, Baddi, Himachal Pradesh –

173205.

Sterility

CDSCO

Jammu

CDL

Kolkata

14.

Pantoprazole Gastro-Resistant Tablets IP

B. No.: TF1037A Mfg dt: 06/2021 Exp dt: 11/2022 Mfd by: M/s. Navkar Lifesciences, Plot

No.76, Lodhi Majra, Industrial Area, Baddi, Distt. Solan ,

Himachal Pradesh.

Dissolution

CDSCO

Sub Zone Bangalore

CDTL

Chennai

15.

Ciprofloxacin Hydrochloride Tablets IP 500 mg

B. No.: 0702620

Mfg dt: 06/2020 Exp dt: 05/2023 Mfd by: M/s.

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

Bangalore -560058.

Dissolution

CDSCO

Sub Zone Bangalore

CDTL

Chennai

16.

Telmisartan Tablets IP

B. No.: CT-10408

Mfg dt: 08/2020 Exp dt: 07/2023

Mfd by: M/s Cosmas Pharmacls Ltd., Buranwala Road, Village: Kotta, P.O.: Baratiwala, Solan, Himachal Pradesh –

174103.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

17.

Amoxycillin and Potassium Clavulanate

Tablets IP

B. No.: PT-0681A Mfg dt: 01/2021 Exp dt: 12/2022

Mfd by: M/s Saitech

Dissolution of Amoxycillin and Clavulanic Acid

Drug Control Department Jharkhand

RDTL

Guwahati

Medicare Pvt. Ltd., Village Kheri, Trilokpur Road, Kala- Amb, Dist. Sirmour, Himachal Pradesh –

173030.

18.

Omeprazole (Delayed- Release) and Domperidone (Sustained- Release) Capsules

B. No.: E2100419

Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s Dr.

Reddys Laboratories Ltd. Village Mauja Thana, Baddi- 173205, Dist. Solan,

Himachal Pradesh.

Assay of Omeprazole and Domperidone

Drug Control Department Assam

RDTL

Guwahati

19.

Misoprostol Tablets IP 200mcg

B. No.: UHT21298 Mfg dt: 09/2021 Exp dt: 08/2023

Mfd by: M/s Unimarck Healthcare Ltd. WHO- GMP Certified Company Plot No. 24, 25 & 37, Sector 6A, SIDCUL, Haridwar-

249403, Uttarakhand.

Assay

Drug Control Department Assam

RDTL

Guwahati

20.

ATENOLOL Tablets IP 50mg

B. No.: ATTJ21001 Mfg dt: 01/2021 Exp dt: 12/2022 Mfd by: M/s Vivek

Pharmachem (India) Ltd., EPIP, Bari Brahmana, Jammu-

181133.

Disintegration and Assay

Drug Control Department Assam

RDTL

Guwahati

21.

Telmisartan Tablets IP 40mg

B. No.: TETY-01 Mfg dt: 04/2021 Exp dt: 03/2023 Mfd by: M/s Nestor Pharmaceuticals

Limited, 11, Western Extension Area, Faridabad-121001,

Haryana, INDIA.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

22.

Telmisartan Tablets

IP 80mg

B. No.: MT212218

Mfg dt: 06/2021

Dissolution

Drug Control

Department

RDTL

Guwahati

Exp dt: 05/2023 Mfd by: M/s Mascot Health Series Pvt.

Ltd., Plot No. 79, 80, Sec. -6A, IIE, Sidcul, Haridwar – 249403,

Uttarakhand.

Assam

23.

Dexamethasone Tablets I.P. 0.5mg

B. No.: DXMT-1003 Mfg dt: 05/2020 Exp dt: 04/2023 Mfd by: M/s Wings Biotech, 43 & 44, HPSIDC, Industrial

Area, Baddi – 173205, Himachal Pradesh.

Assay

Drug Control Department Jharkhand

RDTL

Guwahati

24.

METRONIDAZOLE TABLETS I.P.

B. No.: MT-21D20 Mfg dt: 04/2021 Exp dt: 03/2023

Mfd by: M/s Martin & Brown Bio-sciences K. No. 918/419,

Malkumajra, Nalagarh Road, Baddi, Distt.

Solan, Himachal

Pradesh.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

25.

Metronidazole Tablets IP

B. No.: DMRT-02 Mfg dt: 04/2021 Exp dt: 03/2024 Mfd by: M/s SGS

PHARMACEUTICALS

(P) LTD, E-13/1, Sector – 17, Kavi Nagar Indl. Area, Ghaziabad-201002,

Uttar Pradesh.

Dissolution

Drug Control Department Jharkhand

RDTL

Guwahati

26.

Enteric Coated Rabeprazole Sodium & Domperidone SR Capsules

B. No.: JC-20726

Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s Jineka

Healthcare Pvt. Ltd., 15, Sector 6-B, IIE,

Ranipur, Haridwar-

Assay of Rabeprazole Sodium

Drug Control Department Mizoram

RDTL

Guwahati

249403, Uttarakhand.

27.

Rosuvastatin Calcium Tablets IP 10mg

B. No.: 21S1GTA035 Mfg dt: 01/2021

Exp dt: 12/2022 Mfd by: M/s SYNOKEM

PHARMACEUTICALS LTD. Plot No.: 35-36,

Sector-6A, I.I.E.(SIDCUL),

Ranipur (BHEL),

Haridwar-249403, Uttarakhand.

Dissolution

Drug Control Department Assam

RDTL

Guwahati

28.

Omeprazole Gastro-resistant Capsules I.P.

B. No.: 520-170

Mfg dt: 07/2020 Exp dt: 06/2022 Mfd by: M/s ZEE

LABORATORIES, 47,

Industrial Area, Paonta Sahib – 173025, Himachal

Pradesh.

Dissolution

Drug Control Department Assam

RDTL

Guwahati

29.

Doxofylline Tablets IP 400mg

B. No.: SPTG-20390 Mfg dt: 08/2020

Exp dt: 07/2022 Mfd by: M/s SPECTRUM

FORMULATION PVT.

LTD, Khasra No. 12, Makhanpur, Bhagwanpur, Roorkee, Haridwar –

Uttarakhand.

Dissolution

CDSCO

Sub-Zone Guwahati

RDTL

Guwahati

30.

Dexamethasone Tablets I.P. 0.5mg

B. No.: DPO2004 Mfg dt: 08/2020 Exp dt: 07/2022 Mfd by: M/s Danish Health Care (P) Ltd. 76/27-28, Industrial Estate, Maxi Road, Ujjain – 456010, Madhya Pradesh,

INDIA.

Assay

Drug Control Department Jharkhand

RDTL

Guwahati

31.

BUPRENORPHINE INJECTION I.P.

B. No.: LM 18870

Mfg dt: 012/2020 Exp dt: 011/2026 Mfd by: M/s Cooper pharma Ltd.

C-3, Industrial Area,

Selaqui, Dehradun- 248197, Uttarakhand.

Assay

Drug Control Department Bihar

RDTL

Guwahati

32.

BUPRENORPHINE INJECTION I.P.

B. No.: LM 18730

Mfg dt: 08/2018 Exp dt: 07/2024 Mfd by: M/s Cooper pharma Ltd., C-3, Industrial Area, Selaqui, Dehradun-

248197, Uttarakhand.

Assay

Drug Control Department Bihar

RDTL

Guwahati

33.

ODIMONT-AL

(Montelukast, Levocetirizine HCl & Ambroxol HCl (SR) Tablets)

B. No.: GZOA21003 Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s GKM New Pharma. Plot

No.5, 6, 7 & 8, Pipdic Electronic Park, Thirubuvanai,

Puducherry- 605 107.

Dissolution

CDSCO

Sub-Zone Goa

CDTL

Mumbai

34.

Fluconazole Capsules I.P.

150 mg

B. No.: 4700821

Mfg dt: 11/2021 Exp dt: 10/2023 Mfd by: M/s

Karnataka Antibiotics & Pharmaceutical Pvt. Ltd., Plot No.14, II Phase, Peenya,

Bengaluru – 560 058.

Uniformity of weight

CDSCO

Zonal Office Ahmedabad

CDTL

Mumbai

35.

Methylcobalamin, Alpha Lipoic Acid, Pyridoxine HCI and Folic Acid Capsules (VEMIFOL PLUS CAPSULES)

B. No.: SOC-1911A Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s Symbiosis

Pharmaceuticals Pvt. Ltd. (Plant-3) Plant at: Trilokpur Road, Kala Amb-173030,

Himachal Pradesh.

Assay of Alpha Lipoic Acid

CDSCO

Sub-Zone Baddi

RDTL

Chandigarh

Marketed by: VIVEX PHARMACEUTICALS PVT. LTD. SCO 131,

Sector-110, TDI City,

Mohali, SAS Nagar- 140307.

36.

Iron (III) Hydroxide Polymaltose Complex with Folic Acid Syrup (POLY- FORTE SYRUP)

B. No.: DLK-071C Mfg dt: 11/2021 Exp dt: 04/2023 Mfd by: M/s Digital Vision 176, Mauza Ogli, Nahan Road, Kala-Amb, Distt. Sirmour, Himachal Pradesh -173030. Marketed by: ORISON

PHARMACEUTICALS

51, Industrial Estate, Ambala Cantt-

133006.

Assay of Folic Acid

CDSCO

Sub-Zone Baddi

RDTL

Chandigarh

37.

Diclofenac Diethylamine, Methyl Salicylate, Linseed Oil and Menthol Gel (ARMNAC GEL)

B. No.: 017

Mfg dt: 02/2022 Exp dt: 01/2024 Mfd by: M/s GMH

Laboratories Plot No. 13, Industrial Township, Bhatoli Kalan, Baddi, Distt.

Solan, Himachal

Pradesh -173205.

Assay of Linseed Oil

CDSCO

Sub-Zone Baddi

RDTL

Chandigarh

38.

Doxofylline Tablets IP 400 mg (DOXOSIGN TABLETS)

B. No.: 994-09

Mfg dt: 06/2021 Exp dt: 05/2024 Mfd by: M/s HAB

PHARMACEUTICALS & RESEARCH LIMITED 10,

Pharmacity, SIDCUL, Selaqui, Dehradun –

248011, Uttrakhand.

Dissolution

CDSCO

North-Zone

RDTL

Chandigarh

39.

Ondansetron Injection IP (ONET

INJECTION)

B. No.: EA11107

Mfg dt: 11/2021 Exp dt: 10/2023

Sterility

CDSCO

Sub-Zone Baddi

RDTL

Chandigarh

Mfd by: M/s Elder Labs Limited Vill: Kishanpura, Baddi- Nalagarh Road, Baddi, Distt.-Solan, Himachal Pradesh –

174101.

40.

Cloxacillin Sodium Capsules IP 500 mg (CLOXRID-500 CAPSULES)

B. No.: CLO-2003 Mfg dt: 07/2020 Exp dt: 06/2022

Mfd by: M/s RIDLEY LIFE SCIENCE PVT . LTD. D-1651, DSIDC

Indl. Complex,

Narela, Delhi-110040.

Identification

CDSCO

North-Zone

RDTL

Chandigarh

41.

Amlodipine Tablets IP (AMLOTIS-10 TABLETS)

B. No.: 2113452T001

Mfg dt: 06/2021 Exp dt: 05/2023

Mfd by: M/s Scott-Edil Pharmacia Ltd. Unit- II, Plot No. 21-22, E.P.I.P., Phase-1,

Jharmajri, Baddi, Distt. Solan-173205, Himachal Pradesh,

INDIA.

Assay

CDSCO

Sub-Zone Baddi

RDTL

Chandigarh

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