## Report on List of Drugs, Medical Devices and Cosmetics Declared as Not of Standard Quality/Spurious/Adulterated/Misbranded - July 2023
**1. Executive Summary:**
This report analyzes the provided list of drugs, medical devices, and cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for July 2023. The core purpose of this document is to identify and publicize products failing quality standards, either through manufacturing defects, adulteration, or misbranding, to protect public health. Key findings include a detailed breakdown of the specific products, manufacturers, reasons for failure, and the responsible agencies involved in testing and declaration. The information is crucial for stakeholders in the pharmaceutical and cosmetic industries to understand the types of quality issues arising and to ensure compliance.
**2. Introduction:**
The purpose of this report is to provide an informative overview and analysis of the "List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of JULY 2023," based solely on the text provided. This analysis aims to identify key trends and relevant information for affected stakeholders.
**3. Policy Overview:**
This report does not describe a new policy nor amend an existing policy. It is a listing of items deemed not of standard quality. The core objective, inferred from the provided text, is to identify and publicize drugs, medical devices, and cosmetics that do not meet established quality standards, thereby safeguarding public health.
**4. Background and Rationale:**
This is not a new policy. The list addresses the ongoing problem of substandard, spurious, adulterated, and misbranded drugs, medical devices and cosmetics circulating in the market. The list serves as a public notification to prevent the usage of such items and take appropriate action.
**5. Key Provisions / Changes:**
Since this is not a new policy, but rather a publication of findings, this section details the main components revealed by the list.
* **Identification of Substandard Products:** The list identifies specific drugs, medical devices, and cosmetics that have failed quality testing. This includes details such as the name of the product, batch number, manufacturing and expiry dates, and the name of the manufacturer.
* **Categorization of Failures:** The products are categorized based on the reason for failure, including "Not of Standard Quality," "Spurious," "Adulterated," and "Misbranded." Specific reasons for failure are outlined, such as "Description Hydrolysis," "Identification and Assay," "Dissolution," "Particulate Matter," "Sterility Assay," and "pH."
* **Identification of Responsible Parties:** The list identifies the manufacturing companies responsible for the substandard products.
* **Geographical Information:** The list provides the manufacturing location of the drugs/products as well as the zone of the CDSCO that drew the sample and the laboratory to which the sample was sent.
**6. Target Audience and Stakeholders:**
Based on the provided text, the primary target audience and stakeholders include:
* **Pharmaceutical and Cosmetic Manufacturers:** Especially those named in the list.
* **Regulatory Agencies:** CDSCO (Central Drugs Standard Control Organization) and State Drug Control Departments.
* **Healthcare Professionals:** Doctors, pharmacists, and other healthcare providers who prescribe or dispense these products.
* **Consumers:** Patients and individuals who use these products.
* **Distributors and Retailers:** Involved in the supply chain of drugs and cosmetics.
**7. Implementation Aspects (Inferred):**
* **Responsible agency/bodies mentioned:** The CDSCO (Central Drugs Standard Control Organization) along with various zonal and sub-zonal offices (East Zone CDL Kolkata, West Zone CDL Mumbai, Hyderabad, North Zone Chandigarh, RDTL Guwahati, etc.) and Drug Control Departments of different states (e.g., Drug Control Department Delhi) are the primary responsible bodies for the testing and declaration of substandard products.
* **Timelines or procedures specified:** The list pertains to samples tested and declared in July 2023, indicating a monthly or periodic testing and reporting procedure.
* The list indicates that samples are collected by zonal CDSCO offices and sent to CDL labs.
**8. Expected Outcomes / Impact of Changes:**
The expected outcomes and impact of the dissemination of this list include:
* **Increased Vigilance:** Manufacturers are expected to enhance their quality control measures to avoid being listed.
* **Public Awareness:** Consumers and healthcare professionals will be informed about potentially unsafe products.
* **Regulatory Action:** Regulatory agencies can initiate investigations, recalls, and other enforcement actions against manufacturers of substandard products.
* **Market Correction:** Removal of substandard products from the market, ensuring availability of quality drugs and cosmetics.
**9. Conclusion:**
The "List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of JULY 2023" is a crucial document for maintaining the quality and safety of pharmaceutical and cosmetic products. It provides valuable information to manufacturers, regulatory agencies, healthcare professionals, and consumers, enabling them to take informed decisions and actions to protect public health. The publication of this list highlights the ongoing efforts to monitor and regulate the quality of drugs and cosmetics in the market.
Key Entities Referenced
Folic Acid Tablets IP 5mg: Drug declared as Not of Standard Quality.
Tamsulosin Hydrochloride Dutasteride Tablets: Drug declared as Not of Standard Quality.
Paracin Plus Suspension: Drug declared as Not of Standard Quality.
Hindustan Antibiotics Ltd.: Manufacturer of Ornidazole Ofloxacin Tablets IP declared as Not of Standard Quality.
Lonapam MD 0.5 Clonazepam Mouth Dissolving Tablets 0.5 mg: Drug declared as Not of Standard Quality.
Maxheal Pharmaceuticals India Ltd.: Manufacturer of Maxflux 100 ml Flucloxacillin Oral solution BP 125mg/5ml declared as Not of Standard Quality.
Deep Pharma: Manufacturer of Neomycin Sulphate Ointment USP 20 gm declared as Not of Standard Quality.
Health Biotech Ltd.: Manufacturer of PYRITOL Paracetamol Injection 2ml declared as Not of Standard Quality.
Alkem Health Science: Manufacturer of Pantoprazole Gastro Resistant and Domperidone Prolonged Release Capsules IP, Amoxycillin and Potassium Clavulanate Tablets IP declared as Spurious.
CDSCO: Central Drugs Standard Control Organisation, responsible for drug standards.
List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of JULY – 2023.
Total number of samples tested 1306
Total number of samples declared as of Standard Quality 1252
Total number of samples declared as Not of Standard Quality 51
Total number of samples declared as Spurious 3
Total number of samples declared as Misbranded 0
S.No Name of Drugs/medical Batch Date of Date of Manufactured By Reason for Drawn By From
device/cosmetics No. Manufacture Expiry failure
1 Folic Acid Tablets IP 5mg T112005 05/2022 04/2024 ANG Lifesciences India Ltd., Description & CDSCO East CDL Kolkata
Village Malkumajra, Nalagarh Hydrolysis Zone Kolkata
Road, Baddi, Distt. Solan Products
173205 H.P.
2 Tamsulosin Hydrochloride & GH20067 01/2022 12/2024 Cipla Ltd., Verna Indl. Estate, Identification and CDSCO East Zone CDL Kolkata
Dutasteride Tablets (Urimax D) Goa 403722, India Assay of Kolkata
Dutasteride and
Assay of
Tamsulosin
Hydrochloride
3 Paracin Plus Suspension KCC24A0 04/2023 03/2025 Stadmed Private Limited, 15, Assay of CDSCO East Zone CDL Kolkata
(Ibuprofen and Paracetamol 02A1A Jawpore Road, Kolkata- Ibuprofen and Kolkata
Suspension) 700074 Paracetmol
4 Paracin Plus Suspension KCC24A0 04/2023 03/2025 Stadmed Private Limited, 15, Assay of CDSCO East Zone CDL Kolkata
(Ibuprofen and Paracetamol 01A1A Jawpore Road, Kolkata- Ibuprofen and Kolkata
Suspension) 700074 Paracetmol
5 Ornidazole & Ofloxacin Tablets HOOZ01 07/2022 06/2024 Hindustan Antibiotics Ltd., (A Description CDSCO East Zone CDL Kolkata
IP Govt. of India Enterprise) At: Kolkata
11, W.E.A., Faridabad – 121
001 (Haryana).
6 MONZET (Montelukast Sodium DMZT- 12/2022 11/2024 Kniss Laboratories Pvt. Ltd., Dissolution CDSCO East Zone CDL Kolkata
and Levocetrizine Hydrochloride 2205 No.9, Multe Industrial Estate, Kolkata
Tablets IP) Gerugambakkam, Chennai-
600128.
7 Lonapam® MD 0.5 43L22T01 03/2022 02/2025 Shine Pharmaceuticals Related CDSCO East Zone CDL Kolkata
(Clonazepam Mouth Dissolving Limited, Plot No. 132, Karjan- Substances Kolkata
Tablets 0.5 mg) Vemardi Road, Juni Jitherdi,
Page 1 of 7Ta. Karjan-391240, Dist.:
Vadodara (Gujarat)
8 Lonapam® MD 0.5 43L23T01 02/2023 01/2026 Shine Pharmaceuticals Related CDSCO East Zone CDL Kolkata
(Clonazepam Mouth Dissolving Limited, Plot No. 132, Karjan- Substances Kolkata
Tablets 0.5 mg) Vemardi Road, Juni Jitherdi,
Ta. Karjan-391240, Dist.:
Vadodara (Gujarat)
9 Lonapam® MD 0.5 43L22T03 09/2022 08/2025 Shine Pharmaceuticals Related CDSCO East Zone CDL Kolkata
(Clonazepam Mouth Dissolving Limited, Plot No. 132, Karjan- Substances Kolkata
Tablets 0.5 mg) Vemardi Road, Juni Jitherdi,
Ta. Karjan-391240, Dist.:
Vadodara (Gujarat)
10 Maxflux 100 ml (Flucloxacillin M481005 07/2021 06/2023 Maxheal Pharmaceuticals Assay of CDSCO West CDL Kolkata
Oral solution BP 125mg/5ml) (India) Ltd., 95/6, M.I.D.C. Flucloxacillin Zone Mumbai
Satpur, Nashik, Maharashtra
422 007
11 Maxflux 100 ml (Flucloxacillin M481006 07/2021 06/2023 Maxheal Pharmaceuticals Assay of CDSCO West Zone CDL Kolkata
Oral solution BP 125mg/5ml) (India) Ltd., 95/6, M.I.D.C. Flucloxacillin Mumbai
Satpur, Nashik, Maharashtra
422 007
12 Neomycin Sulphate Ointment 023 03/2023 02/2025 Deep Pharma, Unit-2, Survey Assay of CDSCO CDL Kolkata
USP 20 gm No. 293/3, Behind Jalaram Neomycin Ahmedabad
Mandir, Kalikund Kheda
Road, Dholka, Ahmedabad-
382225, Gujarat
13 PYRITOL (Paracetamol HIPM220 12/2022 11/2024 Health Biotech Ltd., Village: Particulate Matter CDSCO CDL Kolkata
Injection) 2ml 08B Sandoli, Nalagarh Road, Ahmedabad
Baddi, Dist. Solan (HP) India
173205
14 Rabeprazole Gastro-Resistant AT23029 02/2023 01/2025 Alves Healthcare Private Dissolution CDSCO CDL Kolkata
Tablets IP 20 mg Limited, Village Nangal Ahmedabad
Uperla, Swarghat Road,
Tehsil, Nalagarh, Dist. Solan
- 174101 (H.P.), India
15 SN-15 Plus (Serratiopeptidase & DS-407 10/2022 09/2024 Ruby Organics Pvt. Ltd., D- Disintegration CDSCO Hyderabad CDL Kolkata
Diclofenac Potassium Tablets) 79, T.T.C, M.I.D.C, Turbhe,
Navi Mumbai-400705.
Page 2 of 716 Ondansetron Injection IP L3003 11/2022 10/2024 Captab Biotic, Unit-II, Plot Description and Drug Control CDL Kolkata
No.125, EPIP Road, Mauja Particulate Matter Department
Jharmajri, Baddi, Distt. Solan Himachal Pradesh
H.P. 173205.
17 Compound Sodium Lactate ODF 12/2022 11/2024 Haseeb Pharmaceuticals Pvt. Particulate Drug Control CDL Kolkata
Injection IP (Ringer Lactate 221292 Ltd., Plot No. F 9/14, 15, 16, Contamination Department Odisha
Solution for Injection) RL 500 ml MIDC, Nagpur-440016.
18 Diclofenac Sodium, Paracetamol F23018 02/2023 01/2026 Brussels Laboratories Pvt. Assay of CDSCO CDL Kolkata
and Serratiopeptidase Tablets Ltd., 33, Changodar Ind. Serratiopeptidase Ahmedabad
Estate, Sarkhej Bavla Road,
Changodar - 382210,
Ahmedabad, Gujarat.
19 Carbamazepine Tablets IP 200 GCB5 12/2022 11/2024 Super Formulations Pvt. Ltd., DISSOLUTION CDSCO CDTL
mg 16-B & 15-F, Zonal Office Chennai
Industrial Area, Chennai
Maxi Road,
Ujjain (M.P.)-456010.
20 Norfloxacin Tablets IP 400 mg NRT2300 01/2023 12/2024 Vivek Pharmachem (India) DISSOLUTION CDSCO Subzonal CDTL
9 Ltd.,NH-8, Chimanpura, Office Bangalore Chennai
Amer, Jaipur-303 102.
21 Chymovit Forte (Trypsin- DMT0027 01/2023 12/2024 DM PHARMA PRIVATE Uniformity of CDSCO CDTL Mumbai
Chymotrypsin Tablets) J LIMITED., Vill. Bhud, NH- Weight, Average West-Zone
21A, Baddi, Distt. Solan Weight & Mumbai
(H.P.) 173 205 Disintegration test
(Acid stage)
22 Trypsin-Chymotrypsin Tablets DT1624H 12/2022 11/2024 DM PHARMA PRIVATE Uniformity of CDSCO CDTL Mumbai
(Chymnetra-Forte) LIMITED., Vill. Bhud, NH- Weight, & West-Zone
21A, Baddi, Distt. Solan Average Weight Mumbai
(H.P.) 173 205
23 Amoxycillin & Potassium 422-494A 03/2022 02/2024 Zee Laboratories Ltd., Assay CDSCO CDTL Mumbai
Clavulanate Tablets I.P. 625 mg Behind 47, Industrial Area, West-Zone
Paonta Sahib- 173 025 Mumbai
Page 3 of 724 Tropicamide Eye Drops IP 1 % GTC002 05/2022 04/2024 Vivimed Labs Limited., Plot Sterility & Assay CDSCO CDTL Mumbai
w/v No.8, Phase V, IDA, West-Zone
Jeedimetla, Medchal- Mumbai
Malkajgiri, Dist. Telangana
State – 500 055
25 Cyproheptadine Hydrochloride 30489 03/2023 02/2025 Zenith Drugs Pvt. Ltd., 72/5, pH CDSCO Indore CDTL Mumbai
Syrup IP (Hungree Syrup) Muradpura (Orangpura) Dhar
Road, Near Kalaria, Indore
453001 (MP) India
26 AMLODIPINE AND ATENOLOL MDG281 11/2022 10/2024 M.R. HEALTHCARE PVT. Assay of CDSCO Zonal CDTL,
TABLETS IP K LTD. Village : Tanda Mallu, Amlodipine Office Hyderabad HYDERABAD
(ALAMO -AT) Kashipur Road, Ramnagar - Besilate
244715, Dist. Nainital, equivalent to
Uttarakhand( INDIA) Amlodipine Only
27 ONDANSETRON ORALLY GT23030 03/2023 02/2025 Roseate Medicare., Test for CDSCO Zonal CDTL,
DISINTEGRATING TABLETS IP 56B Vill. Anji, Bypass Road, P.O. Disintegration Office Hyderabad HYDERABAD
(ONDAPLUS-MD 4) Barog, Tehsil & Distt. Solan,
173211 (H.P.) INDIA.
28 AMOXYCILLIN AND PM-16064 09/2022 02/2024 PERENNIAL MEDICARE, pH and Assay CDSCO Zonal CDTL,
POTASSIUM CLAVULANATE Shamti, Solan-173212 (H.P.) Office Hyderabad HYDERABAD
ORAL SUSPENSION I.P.
(TRUECLAM DS)
29 ALBENDAZOLE TABLETS I.P. RD09- 10/2022 09/2024 Vance & Health Test for CDSCO Port Office CDTL,
400 mg (FOZY) 2202 Pharmaceuticals Pvt. Ltd., Dissolution Visakhapatnam HYDERABAD
Khasra No. 410, Karondi,
Roorkee-247 667,
Uttarakhand
30 Olmesartan Medoxomil Tablets GT22183 10/2022 09/2024 Theon Pharmaceuticals Ltd., Dissolution CDSCO R DTL
IP 40 mg 1 Vill.Saini Majra, Tehsil North Zone Chandigarh
Nalagarh, Distt. Solan (H.P.)
174101
31 Aluminium Hydroxide (0.291 ML22076 11/2022 10/2024 Mascot Health Series Pvt. Assay of CDSCO R DTL
gm), Magnesium Hydroxide (98 1 Ltd, Plot No. 79,80, Sec-6A, Oxetacaine North Zone Chandigarh
mg) and Oxetacaine (10 mg )Gel IIE, Sidcul, Haridwar 249403
32 Sodium Valproate and Valproic 422-2202 12/2022 11/2024 ZEE LABORATORIES LTD., Identification of CDSCO R DTL
Acid Controlled Release Tablets Behind 47, Industrial Area, Valproic Acid and North Zone Chandigarh
500 mg Paonta Sahib-173025 Assay of Valproic
Page 4 of 7Acid and Sodium
Valproate
33 Rabeprazole Sodium (Enteric RPE-2258 07/2022 06/2024 Apple Formulations Pvt. Ltd., Assay of CDSCO R DTL
Coated) and Domperidone Plot No. 208, Kishanpur, Rabeprazole North Zone Chandigarh
(Sustained Release) Capsules Roorkee-247667 (U.K.) Sodium
(20 mg/30 mg)
34 Itraconazole Capsules 100 mg Z22-293 03/2022 02/2024 Zee Laboratories Ltd., Dissolution CDSCO R DTL
Behind 47, Industrial Area, North Zone Chandigarh
Paonta Sahib-173025
35 Metformin Hydrochloride SGT- 12/2022 11/2024 Saitech Medicare Pvt. Ltd., Assay of CDSCO Sub- RDTL
Prolonged-release and 0624A Village-Kheri, Trilokpur Road, Glimepiride Zone Baddi Chandigarh
Glimepiride Tablets IP Kala-Amb, Distt. Sirmour,
(Glimipulse M1 Tablets) (H.P.) 173030
36 Rosuvastatin Tablets IP SID3056A 11/2022 04/2025 Sun pharma laboratories ltd., Description and Drug Control RDTL
(Rosuvas 10 Tablets) Plot No. 107-108, Namli Assay of Department Delhi Chandigarh
Block, P.O. Ranipool, East- Rosuvastatin
Skkim-737135 Calcium
calculated as
Rosuvastatin
37 Nimesulide and Paracetamol SMP- 01/2023 12/2024 Cyper Pharma, K.No. 825- Uniformity of Drug Control RDTL
Tablets (CDNIM-P TABLETS) 2205 827, Vill.Gullarwala, Sai weight and Assay Department Chandigarh
Road, Baddi, Distt. Solan of Nimesulide and Himachal Pradesh
(H.P.) 173205 INDIA Paracetamol
38 Calcium Carbonate with Vitamin CLF- 11/2022 10/2024 CYPER PHARMA, K.No. Assay of Vitamin Drug Control RDTL
D3 Tablets (CYPCAL-FORTE 22013 825-827, Vill.Gullarwala, Sai D3 Department Chandigarh
TABLETS) Road, Baddi, Tehsil Himachal Pradesh
Nalagarh, Distt. Solan (H.P.)
173205 INDIA
39 Albendazole Tablets IP 400 mg ABD-2206 01/2023 12/2024 CYPER PHARMA, K.No. Dissolution Drug Control RDTL
825-827, Vill.Gullarwala, Sai Department Chandigarh
Road, Baddi, Tehsil Himachal Pradesh
Nalagarh, Distt. Solan (H.P.)
173205
40 Indomethacin Capsules IP IND-2202 02/2023 01/2026 CYPER PHARMA, K.No. Uniformity of Drug Control RDTL
(INDOMETHACIN CAPSULES) 825-827, Vill.Gullarwala, Sai weight and Assay Department Chandigarh
Road, Baddi, Tehsil of Indomethacin Himachal Pradesh
Nalagarh, Distt. Solan (H.P.)
173205 INDIA
Page 5 of 741 Griseofulvin Tablets IP 250 mg GSP- 01/2023 12/2024 CYPER PHARMA, K.No. Uniformity of Drug Control RDTL
(Grisowin-250 Tablets) 22B08 825-827, Vill.Gullarwala, Sai weight and Assay Department Chandigarh
Road, Baddi, Tehsil of Griseofulvin Himachal Pradesh
Nalagarh, Distt. Solan (H.P.)
173205 (India)
42 Ampicillin Capsules IP AMP- 01/2023 12/2024 Cyper Pharma, K.No. 825- Assay of Ampcillin Drug Control RDTL
(ampicillin Capsules IP-250) 22A07 827, Vill. Gullarwala, Sai Trihydrate Department Chandigarh
Road, Baddi, Distt. Solan calculated as Himachal Pradesh
(H.P.) 173205 INDIA Ampicillin
43 Furosemide Tablets IP 40mg T212721 03/2022 02/2024 United Bioceuticals Pvt. Ltd. Dissolution Drug Control RDTL, Guwahati
(Furosemide-40) Plot No. 33C, Industrial Part- Department
IV, Begumpur, Haridwar- Nagaland
249402 Uttarakhand
44 MULTIELECTROLYTE WITH IN703401 03/2023 02/2026 Abaris Healthcare Pvt. Ltd., Particulate Drug Control RDTL, Guwahati
20% w/v DEXTROSE 1 Survey No. 1407-11, Village Contamination, Department Bihar
INJECTION (INTALYTE Rajpur, Tal. Kadi. Dist. Sterility and
(Veterinary) Mehsana-382740 (Gujarat) Description
45 Telmisartan Tablets I.P. 40mg. T101004 09/2021 08/2023 ANG Lifesciences India Ltd., Description Drug Control RDTL, Guwahati
Village Malkumajra, Nalagarh Department Bihar
Road, Baddi, Distt. Solan-
173205 (H.P.), India
46 Paraccetamol Tablets I.P. 500 DGT22- 06/2022 05/2024 ORNATE LABS PVT. LTD. Dissolution and Drug Control RDTL, Guwahati
mg 257 Bela Industrial Estate, Assay Department Bihar
Muzaffarpur- 842005
47 DEXADEC INJECTION TGL0223 02/2023 01/2025 T & G Medicare, Vill. Kunjhal, Sterility and BET Drug Control RDTL, Guwahati
(Dexamethasone Sodium 0317 P.O. Baddi, Dist. Solan, H.P. Department
Phosphate Injection I.P. 2 ml.) Arunachal Pradesh
48 OFLOXACIN & ORNIDAZOLE AT220708 07/2022 06/2024 Accura Care Dissolution of CDSCO Sub Zone, RDTL, Guwahati
TABLETS I.P. (OFNI-OZ) 27 Pharmaceuticals pvt. Ltd., Ofloxacin and Guwahati
Vill. Moginand, Nahan Road, Ornidazole
Kala Amb. Distt- Sirmour
(H.P.) 173030
Page 6 of 7S.No Name of Batch No. Date of Date of Manufactured By Reason for Drawn By From Remarks
Drugs/medical Manufacture Expiry failure
device/cosmetics
49 Pantoprazole Gastro- 23440762 03/2023 02/2025 Alkem Health Science, A Identification & CDSCO CDL The actual manufacturer
Resistant and Unit of Alkem Assay of East Zone Kolkata (as per label claim) has
Domperidone Prolonged Laboratories Limited, Unit- Pantoprazole & Kolkata informed that the impugned
Release Capsules IP 2, Samardung, Karek Domperidone batch of the product has not
(PAN-D) Block, P.O.: Namthang, (Sample is been manufactured by them
South Sikkim-737137 deemed to be and that it is a spurious
Spurious) drug. Thus, the product is
purported to be spurious,
however, the same is
subject to outcome of
investigation.
50 Amoxycillin and 23440774 03/2023 08/2024 Alkem Health Science, A Identification & CDSCO CDL The actual manufacturer
Potassium Clavulanate Unit of Alkem Assay of East Zone Kolkata (as per label claim) has
Tablets IP (CLAVAM Laboratories Limited, Unit- Amoxycillin and Kolkata informed that the impugned
625) 2, Samardung, Karek Clavulanic Acid batch of the product has not
Block, P.O.: Namthang, (Sample is been manufactured by them
South Sikkim-737137 deemed to be and that it is a spurious
Spurious) drug. Thus, the product is
purported to be spurious,
however, the same is
subject to outcome of
investigation.
51 Pantoprazole Gastro- 23440087 01/2023 06/2025 Alkem Health Science, A Dissolution CDSCO CDL The actual manufacturer
resistant Tablets IP Unit of Alkem East Zone Kolkata (as per label claim) has
(PAN 40) Laboratories Limited, Unit- Kolkata informed that the impugned
2, Samardung, Karek batch of the product has not
Block, P.O.: Namthang, been manufactured by them
South Sikkim-737137 and that it is a spurious
drug. Thus, the product is
purported to be spurious,
however, the same is
subject to outcome of
investigation.
Page 7 of 7