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Date: 2022-11-16 Category: Not Applicable State: Union Government Country: India

Drug Alert list for month of October 2022

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

Gazette Notification

  • This gazette notification lists drugs, medical devices, and cosmetics declared as Not of Standard Quality, Spurious, Adulterated, or Misbranded for the month of October 2022.
  • A total of 1280 samples were tested.
  • 1230 samples were declared to be of Standard Quality.
  • 50 samples were declared as Not of Standard Quality.
  • No samples were declared as Spurious or Misbranded.

Key Changes

  • The notification identifies 50 specific drugs, medical devices, and cosmetics that failed quality tests.
  • The reasons for failure include description, disintegration, fineness of dispersion, assay, dissolution, identification, sterility, uniformity of content, bacterial endotoxins, pH, particulate matter, related substances, and uniformity of weight.
  • The products were manufactured by various companies located across India, including Uttarakhand, Himachal Pradesh, Gujarat, Tamil Nadu, and others.
  • The testing was conducted by Drug Control Departments and CDSCO (Central Drugs Standard Control Organization) laboratories across different zones.
  • The specific tests were performed by RDTL (Regional Drugs Testing Laboratory) and CDL (Central Drugs Laboratory).

Impact Analysis

Manufacturers

  • Action Item: Conduct a thorough internal investigation to identify the root cause of the quality failures and implement corrective and preventive actions (CAPA). Review and strengthen quality control processes.

Consumers

  • Action Item: Healthcare providers should be informed to avoid prescribing the listed products. Issue a public advisory to inform consumers about the substandard products and advise them to seek medical advice if they have used these products.

Regulatory Agencies

  • Action Item: Strengthen post-market surveillance and increase the frequency of random drug testing. Enhance collaboration between central and state drug control authorities.

Distributors and Retailers

  • Action Item: Implement a system to quickly identify and remove recalled products from the supply chain. Ensure that all suppliers are compliant with quality standards.

Key Entities Referenced

Drugs, Medical Devices and Cosmetics: Products regulated under the Drugs and Cosmetics Act, 1940, and related rules. Not of Standard Quality/Spurious/Adulterated/Misbranded: Categories of substandard products as defined under the Drugs and Cosmetics Act, 1940. Drug Control Department: State-level regulatory bodies responsible for monitoring the quality of drugs and cosmetics. CDSCO (Central Drugs Standard Control Organization): The national regulatory body for pharmaceuticals and medical devices in India. RDTL (Regional Drugs Testing Laboratory): Regional laboratories responsible for testing drug samples. CDL (Central Drugs Laboratory): The central laboratory for testing and analysis of drugs and cosmetics.
Official Source Record View Original Source →
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List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of October – 2022. Total number of samples tested 1280 Total number of samples declared as of Standard Quality 1230 Total number of samples declared as Not of Standard Quality 50 Total number of samples declared as Spurious - Total number of samples declared as Misbranded - S.No Name of Batch No./Date of Reason for Drawn By From Drugs/medical Manufacture/Date of failure device/cosmetics Expiry/Manufacture d By 1. DRIED FERROUS B. No.: TC21-74 Description Drug Control RDTL SULPHATE & FOLIC Mfg dt: 03/2021 Department Guwahati ACID TABLETS IP Exp dt: 02/2023 Meghalaya Mfd by: M/s. Om Biomedic Pvt. Ltd. Plot No. 68,69,82 & 83, Sector-6A, IIE, SIDCUL, Haridwar- 249 403, Uttarakhand, India. 2. CIPDAN-500 B. No.: CND2101 Description Drug Control RDTL (Ciprofloxacin Mfg dt: 02/2021 Department Guwahati Hydrochloride Tablets Exp dt: 01/2023 Jharkhand IP 500 mg) Mfd by: M/s. DANISH HEALTH CARE (P) LTD. 76/27-28, Industrial Estate, Maxi Road, UJJAIN 456 010 INDIA Madhya Pradesh. 3. HEXIFLOR B. No.: 2664 Disintegration Drug Control RDTL TRIHEXYPHENIDYL Mfg dt: 04/2022 Department Guwahati HCL TABLETS IP Exp dt: 03/2025 Jharkhand 2 mg Mfd by: M/s. MARIGOLD REMEDIES 83/A, Kohinoor Industries Compound, Phase-II, GIDC, Vatva, Ahmedabad- 382 445. Page 1 of 114. Airmol®-650 Tablets B. No.: LTA-20967 Fineness of Drug Control RDTL (Paracetamol Mfg dt: 12/2021 dispersion and Department Guwahati Dispersible Tablets BP Exp dt: 11/2024 Disintegration Jharkhand 650 mg) Mfd by: M/s. Lifevision Healthcare Plot No. 140-141, E.P.I.P.,Phase-1 Jarmajri, Baddi, Solan, Himachal Pradesh -174 103. 5. Esolip 40 B. No.: TGD210190 Assay Drug Control RDTL (Esomeprazole Mfg dt: 03/2021 Department Guwahati Gastro-Resistant Exp dt: 02/2023 Bihar Tablets IP 40 mg) Mfd by: M/s. DM PHARMA PRIVATE LIMITED, Vill. Bhud, NH-21 A, Baddi, Distt. Solan, Himachal Pradesh- 173205. 6. Cantop-40 Tablets B. No.: SPT170513D Dissolution Drug Control RDTL (Pantoprazole Mfg dt: 04/2022 Department Guwahati Tablets IP) Exp dt: 09/2023 Bihar Mfd by: M/s. Salus Pharmaceuticals, 480/211, Harraipur, PO Gurumajra, Teh. Baddi, Distt.-Solan, Himachal Pradesh- 173205 7. OMZOLE B. No.: 22C06001 Dissolution Drug Control RDTL (Omeprazole Gastro Mfg dt: 05/2022 in Acid stage Department Guwahati Resistant Capsules IP) Exp dt: 04/2024 Bihar Mfd by: M/s. KRAS PHARMACEUTICAL S PVT. LTD. C-15, Industrial Area, Phase-II, Fatwah- 803201, Bihar. 8. Montek® LC B. No.: SIC1932A Identification and Drug Control RDTL (Montelukast Sodium Mfg dt: 08/2021 Assay of Department Guwahati & Levocetirizine Exp dt: 01/2024 Montelukast Assam Hydrochloride Tablets Mfd by: M/s. Sun IP) pharma laboratories ltd. Plot No. 107-108, Namli Block, P.O. Ranipool, East- Page 2 of 11Sikkim-737135. 9. LEVOCETIRIZINE B. No.: 0070 Description Drug Control RDTL TABLETS IP. 5 mg. Mfg dt: 12/2021 Department Guwahati Exp dt: 11/2023 Jharkhand Mfd by: M/s. HINDUSTAN ANTIBIOTICS LTD. Pimpri, Pune-411018, INDIA Maharashtra. 10. PAMAGIN-P B. No.: PPT21010SL Dissolution Drug Control RDTL (Diclofenac Sodium Mfg dt: 07/2021 Department Guwahati and Paracetamol Exp dt: 06/2024 Jharkhand Tablets IP) Mfd by: M/s. Shiva Biogenetic Laboratories Pvt. Ltd. Village Manpura Baddi, Dist Solan, Himachal Pradesh – 174101. 11. MARKMOX-500 B. No.: OC-1085 Assay Drug Control RDTL (Amoxycillin Capsules Mfg dt: 02/2022 Department Guwahati I.P. 500 mg) Exp dt: 01/2024 Meghalaya Mfd by: M/s. J.R.S. Oryx Pharmaceuticals (P) Ltd., 217-218, Sector 3, H.S.I.I.D.C. KARNAL-132001 (India) Haryana. 12. ONKAM (Ondansetron B. No.: 31035 Assay Drug Control RDTL Oral Solution IP) Mfg dt: 03/2021 Department Guwahati Exp dt: 02/2023 Assam Mfd by: M/s. Gujarat Pharmalab Pvt. Ltd. Block No.447, Nr. Bajaj Food Ltd., Changodar-382213 Dist. Ahmedabad, Gujarat (India). 13. CHROMOSTAT B. No.: CH21014 Sterility Drug Control RDTL INJECTION 2 ml Mfg dt: 08/2021 Department Guwahati Exp dt: 07/2024 Jharkhand Mfd by: M/s. Life Pharmaceuticals Pvt. Ltd., 3/2B, Orient Page 3 of 11Row, Kolkata- 700017. At. 53 (P) & 54(P), Uluberia Industrial Growth Centre, Howrah – 711316, West Bengal. 14. Pantop-DSR B. No.: SPM211927 Identification and Drug Control RDTL (Pantoprazole Sodium Mfg dt: 12/2021 Assay Department Guwahati Exp dt: 11/2023 Gastro-resistant & Mizoram Mfd by: M/s. ARISTO Domperidone Pharmaceuticals Prolonged release Private Limited Capsules IP) Plot Nos.: 2040-46, N.H. 10, Baghey Khola, P.O.Majhitar, East-Sikkim, 737136. 15. Uriflo -D (Tamsulosin B. No.: MT223309 Uniformity of CDSCO CDL HCl & Dutasteride Mfg dt: 07/2022 Content of East Zone Kolkata Exp dt: 06/2024 Tablets) Tamsulosin Kolkata Mfd by: M/s. Mascot Hydrochloride Health Series Pvt. Ltd., Plot No. 79, 80, Sector -6A, IIE, Sidcul, Haridwar - 249403, Uttarakhand, India 16. Misoprostol Tablets B. No.: RT220304 Assay CDSCO CDL I.P. 200 mcg Mfg dt: 03/2022 East Zone Kolkata Exp dt: 02/2024 Kolkata Mfd by: M/s. Ridley Life Science Pvt. Ltd., D-1651, DSIDC, Indl. Complex, Narela, Delhi -110040. 17. Silodosin 4 mg and B. No.: UGT22309 Disintegration CDSCO CDL Dutasteride Mfg dt: 03/2022 East Zone Kolkata Exp dt: 02/2024 0.5 mg Tablets Kolkata Mfd by: M/s. Unimark Healthcare Ltd., Plot No. 24, 25 & 37, Sector 6A, SIDCUL, Haridwar 249 403, Uttarakhand. 18. DIACOWIN-PLUS B. No.: 521-263 Identification of CDSCO CDL Capsules (Prebiotic & Mfg dt: 09/2021 Bifidobacteruim East Zone Kolkata Exp dt: 08/2023 Probiotics Capsules) specIes, Kolkata Page 4 of 11Mfd by: M/s. Zee Saccharomyces Laboratories, 47 boulardi, Industrial Area, Streptococcus Paonta Sahib -173 thermophilus and 025, Himachal Assay of Pradesh. Lactobacillus species, Bifidobacterium species, Saccharomyces boulardi and Streptococcus thermophilus 19. Albendazole Tablets B. No.: AT10-22-245 Assay and CDSCO CDL I.P. 400 mg Mfg dt: 07/2022 Dissolution East Zone Kolkata Exp dt: 06/2024 Kolkata Mfd by: M/s. Ornate Labs Pvt. Ltd., Bela Industrial Estate, Muzaffarpur -842 005, Bihar. 20. L - Methylfolate B. No.: PF8CY03 Description CDSCO CDL Tablets Mfg dt: 04/2022 East Zone Kolkata Exp dt: 03/2024 Kolkata Mfd by: M/s. Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27 - 30, Sector – 8A, I.I.E. SIDCUL, Ranipur, Haridwar – 249 403, Uttarakhand. 21. Ltira – 250 B. No.: T22026 Dissolution CDSCO CDL (Levetiracetam Tablets Mfg dt: 04/2022 East Zone Kolkata Exp dt: 03/2024 IP 250 mg) Kolkata Mfd by: M/s. Rebase Lifescience Pvt. Ltd., Block No. 6, Plot No. 11 & 12, Nr. Amrut Dairy, Lalpur Daskroi, Ahmedabad, Gujarat 382 430. 22. Metronidazole Tablets B. No.: BT28130 Dissolution CDSCO CDL I.P. 400 mg Mfg dt: 01/2022 East Zone Kolkata Exp dt: 12/2024 Kolkata Mfd by: M/s. Page 5 of 11Gluconate Health Limited, 1, Health Institute Road, Kolkata – 700065. 23. PREDACE-4 B. No.: PREA006 Assay CDSCO CDL (Methylprednisolone Mfg dt: 06/2021 and Related South Zone Kolkata Exp dt: 05/2023 Tablets IP 4 mg) Substances Chennai Mfd by: M/s. Malik Life Sciences Pvt. Ltd., Plot No. 16, Vardhman Indl. Estate, Bahadarpur, Saini, NH 58, Haridwar 247667, Uttarakhand. 24. TILVIT (Multivitamin B. No.: TAI1D4 Assay of Vitamin CDSCO CDL Infusion) 10 ml Mfg dt: 11/2021 A, Nicotinamide South Zone Kolkata Exp dt: 01/2023 and Thiamine Chennai Mfd by: M/s. Tablets Hydrochloride (India) Ltd., 179, T. H. Road, Chennai- 600 081, Tamil Nadu. 25. Otocap Capsules B. No.: CY039 Assay of Alpha CDSCO CDL (Alpha Lipoic Acid Mfg dt: 01/2022 Lipoic Acid South Zone Kolkata Exp dt: 06/2023 & Ginkgo Biloba Chennai Mfd by: M/s. Methylcobalamin Chromium Picolinate Ishaanav and Description Methylcobalamin, Zinc Nutraceuticals Pvt. Vitamin B6 and Ltd., Khasra No. Vitamin C Capsules) 1016, Central Hope Town, Camp Road, Selaqui, Dehradun (Uttarakhand) 248 011. 26. Mycobal-Plus B. No.: GFM482102 Identification of CDSCO CDL Capsules Mfg dt: 01/2022 Methylcobalamin South Zone Kolkata Exp dt: 12/2023 (Methylcobalamin, & Chennai Mfd by: M/s. Alpha Lipoic Acid Assay of Progressive Pyridoxine Methylcobalamin Lifesciences Pvt. Ltd., Hydrochloride & Folic & Latherdevahoon, Acid Capsules) Alpha Lipoic Acid P.O. Jhabrera, Roorkee, Dist. Haridwar -247665 Uttarakhand. Page 6 of 1127. KINGCATH (Nelaton B. No.: UNBHC01 Effective length of CDSCO CDL Catheter / Urethral Mfg dt: 03/2021 the catheter, South Zone Kolkata Catheter) Exp dt: 02/2024 overall length of Chennai Mfd by: M/s. the catheter and Morisons Lifecare Effective shaft Pvt. Ltd., No. 3, Anna length of the Street, Padikuppam, catheter Chennai – 600 107, Tamil Nadu. 28. Beekom-L (B-Complex B. No.: HBK-21008 Description, pH, Drug Control CDL with Liver Extract) – Mfg dt: 06/2021 Particulate Matter Department Kolkata 30 ml Exp dt: 05/2023 and Sterility Himachal Mfd by: M/s. Health Pradesh Biotech Ltd., Nalagarh Road, Baddi 173 205, Distt. Solan, Himachal Pradesh. 29. Enalapril Maleate B. No.: T22093 Dissolution and CDSCO CDL Tablets I.P. 5 mg Mfg dt: 05/2022 Assay Ahmedabad Kolkata Exp dt: 04/2024 Mfd by: M/s. Trugen Pharmaceuticals Pvt. Ltd., Vill. Tejjupur, Near Chodiale Rly. Station, Roorkee, Distt. Haridwar, Uttarakhand – 247 661. 30. Pilogrel - A 75 B. No.: ALA21002 Description and CDSCO CDL (Clopidogrel and Mfg dt: 02/2021 Related Hyderabad Kolkata Aspirin Tablets I.P.) Exp dt: 01/2023 Substances for Mfd by: M/s. Aspirin (Free Psychotropics India Salicylic Acid) Limited, Plot No. 46 & 49, Sector - 6A, IIE, SIDCUL, Ranipur, Haridwar -249403, Uttarakhand. 31. Levocetirizine B. No.: 22112701 Dissolution CDSCO CDL Dihydrochloride and Mfg dt: 01/2022 Guwahati Kolkata Montelukast Sodium Exp dt: 12/2023 Tablets IP Mfd by: M/s. Mercury Laboratories Ltd., Unit No. 2 , Halol- Baroda Road, Village: Jarod, Tal: Page 7 of 11Waghodia, Dist. Vadodara – 391 510, Gujarat. 32. RL- 500 ml, B. No.: 111003 Bacterial Drug Control CDL Compound Sodium Mfg dt: 11/2021 endotoxins and Department Kolkata Lactate Injection IP Exp dt: 10/2023 Sterility Jabalpur (Ringer Lactate Mfd by: M/s. Ives Solution for Injection Drugs (India) Pvt. I.P.) Ltd., Works: Ghatabillod, Dist. Dhar, H.O. 504, Chetak Center, R.N.T. Marg, Indore - 1(India). 33. RL- 500ml, B. No.: S2FBV17 Sterility Drug Control CDL Compound Sodium Mfg dt: 02/2022 Department Kolkata Lactate Injection IP Exp dt: 01/2024 Odisha (Ringer Lactate Mfd by: M/s. Swaroop Solution for Inj.) Pharmaceuticals Pvt. Ltd., A-10, Tala Nagari Industrial Area, Aligarh – 202 001, Uttar Pradesh. 34. RL- 500ml, B. No.: S2FBV19 Bacterial Drug Control CDL Compound Sodium Mfg dt: 02/2022 endotoxins Department Kolkata Lactate Injection IP Exp dt: 01/2024 and Odisha (Ringer Lactate Mfd by: M/s. Swaroop Sterility Solution for Inj.) Pharmaceuticals Pvt. Ltd., A-10, Tala Nagari Industrial Area, Aligarh – 202 001, Uttar Pradesh. 35. RL- 500ml, B. No.: 112041 Bacterial Drug Control CDL Compound Sodium Mfg dt: 12/2021 endotoxins Department Kolkata Lactate Injection IP Exp dt: 11/2023 and Odisha (Ringer Lactate Mfd by: M/s. Ives Sterility Solution for Injection Drugs (India) Pvt. I.P.) Ltd., Works: Ghatabillod, Distt. Dhar, H.O. 504, Chetak Center, R.N.T. Marg, Indore - 1(India). 36. RL-500ml, B. No.: 107005 Sterility Drug Control CDL Compound Sodium Mfg dt: 07/2021 Department Kolkata Lactate Injection IP Exp dt: 06/2023 Odisha (Ringer Lactate Mfd by: M/s. Ives Page 8 of 11Solution for Injection Drugs (India) Pvt. I.P.) Ltd., Works: Ghatabillod, Distt. Dhar, H.O. 504, Chetak Center, R.N.T. Marg, Indore - 1(India). 37. RL-500ml, B. No.: 112076 Bacterial Drug Control CDL Compound Sodium Mfg dt: 12/2021 endotoxins Department Kolkata Lactate Injection IP Exp dt: 11/2023 and Odisha (Ringer Lactate Mfd by: M/s. Ives Sterility Solution for Injection Drugs (India) Pvt. I.P.) Ltd., Works: Ghatabillod, Distt. Dhar, H.O. 504, Chetak Center, R.N.T. Marg, Indore - 1(India). 38. RL-500ml, B. No.: 203030 Bacterial Drug Control CDL Compound Sodium Mfg dt: 03/2022 endotoxins Department Kolkata Lactate Injection IP Exp dt: 02/2024 and Odisha (Ringer Lactate Mfd by: M/s. Ives Sterility Solution for Injection Drugs (India) Pvt. I.P.) Ltd., Works: Ghatabillod, Distt. Dhar, H.O. 504, Chetak Center, R.N.T. Marg, Indore - 1(India). 39. RL-500ml, B. No.: S2FBZ324 Bacterial Drug Control CDL Compound Sodium Mfg dt: 11/2021 endotoxins Department Kolkata Lactate Injection IP Exp dt: 10/2023 and Odisha (Ringer Lactate Mfd by: M/s. Swaroop Sterility Solution for Inj.) Pharmaceuticals Pvt. Ltd., A-10, Tala Nagari, Industrial Area, Aligarh - 202001, Uttar Pradesh. 40. RL-500ml, B. No.: S2FBV24 Bacterial Drug Control CDL Compound Sodium Mfg dt: 02/2022 endotoxins Department Kolkata Lactate Injection IP Exp dt: 01/2024 and Odisha (Ringer Lactate Mfd by: M/s. Swaroop Sterility Solution for Injection) Pharmaceuticals Pvt. Ltd., A-10, Tala Nagari, Industrial Page 9 of 11Area, Aligarh - 202001, Uttar Pradesh. 41. RL- 500ml, B. No.: S2FBV30 Bacterial Drug Control CDL Compound Sodium Mfg dt: 02/2022 endotoxins Department Kolkata Lactate Injection IP Exp dt: 01/2024 Odisha (Ringer Lactate Mfd by: M/s. Swaroop Solution for Injection) Pharmaceuticals Pvt. Ltd., A-10, Tala Nagari, Industrial Area, Aligarh - 202001, Uttar Pradesh. 42. NS (Sodium Chloride B. No.: SIFBZ794 Bacterial Drug Control CDL Injection IP) Mfg dt: 10/2021 endotoxins Department Kolkata (0.9% w/v) – 500 ml Exp dt: 09/2023 Odisha Mfd by: M/s. Swaroop Pharmaceuticals Pvt. Ltd., A-10, Tala Nagari Industrial Area, Aligarh - 202 001, Uttar Pradesh. 43. Fenofibrate Tablets B. No.: MG22007 Uniformity of CDSCO CDTL I.P. 160 mg Mfg dt: 04/2022 weight West Zone Mumbai Exp dt: 03/2024 Mumbai Mfd by: M/s. Laboratories Griffon Pvt. Ltd., 56, Nelson Manickam Road, Aminijkarai, Chennai- 600 029, Tamil Nadu. 44. CLARIFORD-500 B. No.: HTN303C Dissolution and CDSCO CDTL (Clarithromycin Tablets Mfg dt: 03/2020 Assay West Zone Mumbai IP 500 mg) Exp dt: 02/2023 Mumbai Mfd by: M/s. Himalaya Meditek Pvt. Ltd., Plot No. 35 & 36, Pharmacity, Selaqui, Industrial Area, Dehradun- 248197, Uttarakhand. 45. ONDASETRON B. No.: T351001 Dissolution and CDSCO CDTL TABLETS IP 4 mg Mfg dt: 08/2021 Assay Zonal Office Hyderabad Exp dt: 07/2023 Hyderabad Mfd by: M/s. ANG Lifesciences India Page 10 of 11Ltd, Village Malkumajra Nalagarh Road, Baddi, Distt. Solan-173205 (H.P). 46. MONTELUKAST B. No.: T2203068 Related CDSCO RDTL TABLETS IP Mfg dt: 03/2022 Substances North Zone Chandigarh Exp dt: 02/2024 Mfd by: M/s. Rhydburg Pharamaceuticals Ltd., C-2 & 3, S.I.E.L., Selaqui, Dehradun, Uttarakhand (India). 47. Bromhexine B. No.: G22120 Assay of CDSCO RDTL Hydrochloride Mfg dt: 07/2022 Bromhexine Sub-Zone Chandigarh Tarbutaline Sulphate Exp dt: 06/2024 Hydrochloride Baddi Guaiphenesin and Mfd by: M/s. Healcure Menthol Syrup Lifesciences Plot No. (CINAFROZ BR 73D, HPSIDC, COUGH SYRUP) Industrial Area, Baddi, Distt. Solan Himachal Pradesh - 173205 48. Nandrolone Decanoate B. No.: SI-407 Assay of CDSCO RDTL USP 250 mg/ml Mfg dt: 10/2020 Nandrolone North Zone Chandigarh (DECAGEN) Exp dt: 09/2023 Decanoate Mfd by: M/s. Code No. : PB/Drugs/1633- B & PB/Drugs/1619- OSP. 49. Pantoprazole Sodium B. No.: SAI-289 Assay CDSCO RDTL Gastro-Resistant Mfg dt: 12/2021 North Zone Chandigarh Tablets (PANTARIO - Exp dt: 11/2023 40 TABLETS) Mfd by: M/s. Anon Pharmaceutical A-1, R.I.A. Harsuliya- 303005, Rajasthan. 50. MIDAZOLAM B. No.: MDM-155A pH and Assay CDSC RDTL INJECTION IP Mfg dt: 03/2022 Sub Zone Chandigarh Exp dt: 02/2024 Jammu Mfd by: M/s. PUSHKAR PHARMA Bhandariwala, Kheri, Kala-Amb-173030 Himachal Pradesh. Page 11 of 11

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