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Recall Alert: Drug Product; Capex 500mg Tablet (Batch# 2040006) by M/s. Rotex Pharma, Islamabad

Asad Ullah Recall Alerts

Recall Alert

DRAP Alert NoNoI/S/04-23-23
Action Date16th February 2023
Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
3. General Public
Product(s) Affected Capex 500mg Tab
Composition: Capacetiabine
Manufactured by: M/s. Rotex Pharma, Islamabad
Batch No. 2040006
Problem / Issue DRAP received a complaint that a drug product Capex 500mg Tab contains a hair punch within the tablet, which shows adulterated quality which may compromise the quality of drugs.
Action Initiated-The manufacturing company/registration holder has been directed to immediately recall the defected batch of product from the market.

-All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying this product batch. The remaining stock should be quarantined and returned to the supplier/company.

-Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk.

-Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer/company.

-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

-Please click here for further information on problem reporting to DRAP.
Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have experienced any problem that may be related to taking or using this product.

-All drug products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

    Recall Alert: Drug Product; Mefco 50mg/5mL Suspension (Batch # 21053) by M/s Eros Pharmaceuticals, (Pvt) Ltd, Karachi .

    Asad Ullah Recall Alerts

    Recall Alert

    DRAP Alert NoNoI/S/01-23-02
    Action Date23rd January 2023
    Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
    2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
    3. General Public
    Product(s) Affected Mefco 50mg/5mL Suspension,
    Active Ingredient(s): Mefenamic Acid
    Company: M/s. Eros Pharmaceuticals (Pvt) Ltd, Karachi.
    Batch No. 21053
    Manufacturing Date: 09-2022
    Expiry Date: 09-2024
    Problem / Issue CDL Karachi has declared the batch No. 21053 of Mefco 50mg/5mL Suspension, manufactured by M/s. Eros Pharmaceuticals (Pvt) Ltd, Karachi. as substandard drug product.
    Action Initiated-The manufacturing company has been directed to immediately recall the defected batch of product from the market.

    -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

    -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

    -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
    Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

    -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

    -Please click here for further information on problem reporting to DRAP.
    Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

    -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
      Mefco-50mg-Suspension-Eros-PharmaDownload

      Recall Alert: Drug Product; Santodex Opthalmic Ointment (Batch # BJ-082) by M/s Sante (Private) Limited, Karachi .

      Asad Ullah Recall Alerts

      Recall Alert

      DRAP Alert NoNoI/S/01-23-03
      Action Date23rd January 2023
      Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
      2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
      3. General Public
      Product(s) Affected Santodex Opthalmic Ointment,
      Active Ingredient(s): Tobramycin 3mg/g & dexamethasone 1mg/g
      Company: M/s. Sante (Private) Limited, Karachi
      Batch No. BJ-082
      Manufacturing Date: 04-2022
      Expiry Date: 04-2024
      Problem / Issue CDL Karachi has declared the batch No. BJ-082 of Santodex Opthalmic Ointment, manufactured by M/s. Sante (Private) Limited, Karachi as substandard drug product.
      Action Initiated-The manufacturing company has been directed to immediately recall the defected batch of product from the market.

      -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

      -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

      -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
      Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

      -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

      -Please click here for further information on problem reporting to DRAP.
      Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

      -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
        Santodex-oint-Recall-AlertDownload

        Recall Alert: Drug Product; Fenbar 50mg Tablets (Batch # 2752) by M/s Usawa Pharmaceuticals, Risalpur.

        Asad Ullah Recall Alerts

        Recall Alert

        DRAP Alert NoNoI/S/01-23-05
        Action Date25th January 2023
        Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
        2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
        3. General Public
        Product(s) Affected Fenbar 50mg Tablet,
        Active Ingredient(s): Diclofenac Sodium
        Company: M/s. Usawa Pharmaceuticals, Risalpur.
        Batch No. 2752
        Manufacturing Date: 04-2022
        Expiry Date: 04-2025
        Problem / Issue CDL Karachi has declared the batch No. 2752 of Fenbar 50mg Tablet manufactured by M/s.Usawa Pharmaceuticals, Risalpur as substandard drug product.
        Action Initiated-The manufacturing company has been directed to immediately recall the defected batch of product from the market.

        -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

        -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

        -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
        Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

        -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

        -Please click here for further information on problem reporting to DRAP.
        Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

        -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
          Fenbar-50mg-Tab-Recall-Usawa-RisalpurDownload

          Recall Alert: Drug Product; Paracet 1g/100mL Infusion by M/s Standpharm Pakistan Pvt Ltd, Lahore.

          Asad Ullah Product Recalls, Recall Alerts, Safety Info

          Recall Alert

          DRAP Alert NoNoI/S/01-23-43
          Action Date3rd January 2023
          Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
          2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
          3. General Public
          Product(s) Affected Paracet 1g/100mL Infusion,
          Active Ingredient(s): Paracetamol
          Company: M/s. Standpharm Pakistan Pvt Ltd, Lahore
          Batch No. CIJI70
          Manufacturing Date: 20-09-2022
          Expiry Date: 20-09-2024
          Problem / Issue CDL Karachi has declared the batch No. CIJI70 of Paracet 1g/100ml Infusion manufactured by M/s. Standpharm Pakistan (Pvt.) Ltd., Lahore as substandard & adulterated drug product.
          Action Initiated-The manufacturing company has been directed to immediately recall the defected batch of product from the market.

          -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

          -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

          -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
          Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

          -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

          -Please click here for further information on problem reporting to DRAP.
          Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

          -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
            Paracet-1g-Inj-StandpharmDownload

            Voluntary Recall Alert: Drug Product; Cytotol 200mcg Tablets (Batch # 176,177,178,179,180) by M/s Saffron Pharmaceutical, Faisalabad

            Asad Ullah Product Recalls, Recall Alerts, Safety Info

            Voluntary Recall Alert

            DRAP Alert NoNoI/S/12-22-42
            Action Date20th December 2022
            Target Audience1.Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
            2.Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
            3. General Public
            Product(s) Affected Cytotol 200mcg Tablets,
            Active Ingredient(s): Misoprostol
            Company: M/s. Saffron Pharmaceutical Faisalabad
            Batch No. 176,177,178,179,180
            Problem / Issue Saffron Pharmaceuticals (Pvt.) Limited has initiated a voluntary recall of batch No. 176,177,178,179,180 of their product “Cytotol 200mcg Tablet”.
            Action Initiated-The manufacturing company is recalling the defected batches of product from the market.

            -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

            -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

            -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
            Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

            -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

            -Please click here for further information on problem reporting to DRAP.
            Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

            -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
              Voluntary-Recall-of-Cytotol-200mcg-TabletsDownload

                Recall Alert: Drug Product; Tosson 0.4mg SR Capsule by M/s MTI Medical Pvt Ltd, Lahore.

                Asad Ullah Recall Alerts

                Recall Alert

                DRAP Alert NoNoI/S/12-22-41
                Action Date5th December 2022
                Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
                2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
                3. General Public
                Product(s) Affected Tosson 0.4mg SR Capsules,
                Active Ingredient(s): Tamsulosin
                Company: M/s. MTI Medical Pvt Ltd, Lahore
                Batch No. 487
                Problem / Issue DTL Lahore has declared the Batch No. 487 of Tosson SR 0.4mg Capsule manufactured by M/s. MTI medical Lahore as substandard drug product.
                Action Initiated-The manufacturing company has been directed to immediately recall the defected batch of product from the market.

                -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

                -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

                -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
                Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

                -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

                -Please click here for further information on problem reporting to DRAP.
                Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

                -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
                  TOSSON-SR-0.4MG-CAPSULEDownload

                  Recall Alert: Drug Product; Ximex 100mg/5mL Suspension by Farmaceutics International Karachi

                  Asad Ullah Product Recalls, Recall Alerts, Safety Info

                  Recall Alert

                  DRAP Alert NoNoI/S/11-22-39
                  Action Date30th November 2022
                  Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
                  2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
                  3. General Public
                  Product(s) Affected Ximex 100m/5mL Suspension,
                  Active Ingredient(s): Cefixime 100mg/5mL
                  Company: M/s. Farmaceutics International Karachi
                  Batch No. F-C-539
                  Manufacturing Date: 06-2022
                  Expiry Date: 06-2024
                  Problem / Issue Federal Government Analyst, CDL Karachi has declared the batch No. F-C-539 of product ‘Ximex 100mg/5mL Suspension” manufactured by M/s. Farmaceutics International Karachi, as of substandard quality based on the analysis report.
                  Action Initiated-The manufacturing company has been directed to immediately recall the defected batch of product from the market.

                  -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

                  -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

                  -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
                  Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

                  -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

                  -Please click here for further information on problem reporting to DRAP.
                  Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

                  -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
                    Ximex-100mg-Suspension-Recall-AlertDownload

                    Recall Alert: Drug Product; Kempol 120ml/5mL Pediatric Syrup by M/s Alkemy Pharmaceutical Laboratories Pvt Ltd Hyderabad

                    Asad Ullah Product Recalls, Recall Alerts

                    Recall Alert

                    DRAP Alert NoNoI/S/11-22-39
                    Action Date30th November 2022
                    Target Audience1. Pharmacists and Chemists at Distributions, Pharmacies and Medical Stores
                    2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at Hospitals, Clinics and Healthcare Providing Institutions
                    3. General Public
                    Product(s) Affected Kempol 120mg/5mL Syrup,
                    Active Ingredient(s): Paracetamol 120mg/5mL
                    Company: Ms. Alkemy Pharmaceutical Laboratories Pvt Ltd Hyderabad
                    Batch No. P-707
                    Manufacturing Date: 09-2022
                    Expiry Date: 08-2024
                    Problem / Issue Federal Government Analyst, CDL Karachi has declared the Batch No. P-707 of product ‘Kempol 120mg/5mL Syrup” manufactured by M/s. Alkemy Pharmaceutical Laboratories Pvt Ltd Hyderabad and declared it as “Substandard” based on the analysis.
                    Action Initiated-The company is directed to immediately recall the defected batch of product from the market.

                    -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above-mentioned batch of product to the supplier / importer / company.

                    -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk.

                    -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
                    Advice for Healthcare Professionals-DRAP requests increase vigilance within the supply chains of healthcare institutions and hospital pharmacies to identify and return the defective batch(es) of this product to the importer / company.

                    -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.

                    -Please click here for further information on problem reporting to DRAP.
                    Advice for Consumers-Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider(s) if they have had experienced any problem that may be related to taking or using this product.

                    -All drug products must be obtained from the authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubt, please seek advice from your pharmacist.
                      Kempol-120ml-Syrup-Recall-AlertDownload

                      Rapid Alert: Drug Product; Falsified Restane Inhalational Solution Identified and Confiscated

                      Asad Ullah Product Recalls, Recall Alerts

                      Rapid Alert

                      DRAP Alert NoNoI/S/12-22-40
                      Action Date1st December 2022
                      Target Audience• Regulatory Field Force
                      • Healthcare Professionals- Anesthesiologist, Surgeons, Pharmacists, and Nurses
                      • Pharmacists and Chemists at Distribution, Institutional suppliers
                      • General Public
                      Problem StatementDuring the surveillance activities in different Hospitals of Punjab, Regulatory Field Force had drawn samples of this product for test/analysis. The Provincial Drugs Testing Laboratory, Faisalabad has declared the samples as spurious and adulterated.
                      The product detail is as under: –

                      Therapeutic Good Affected:-

                      SrProduct NameCompositionBatch #Manufactured by (as stated on label)Marketed by
                      (as label)
                      1
                      RESTANE Inhalation Solution 100ml
                      		IsofluraneN0111B24
                      N0892A10
                      M/s Piramal Critical Care, Inc. Schelden Circle Bethlehem PA 18017, USA
                      		Allied Distributors 103-K, Block-2 P.E.C.H.S, Karachi Pakistan.
                      Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities at Health Facilities (Hospitals) in addition to markets and confiscate these batches of product. All Pharmacists and chemists working at Hospital distributions and Pharmacies should immediately check the stock and stop supplying these batches of product. The remaining stock should be quarantined immediately, and supplier’s information should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) in order to ensure the removal of this products.
                      Advice for Healthcare Professionals-DRAP requests increased vigilance at hospitals and within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Anesthesiologists and the supporting staff involved in surgical procedures where anesthetics are involved should remain vigilant about the suspected batches of said products.

                      -Adverse reactions or quality problems experienced with the use of this product shall be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.

                      -Please click here for further information on problem reporting to DRAP.
                      Advice for Consumers-If you are intending to plan any surgeries where anesthetic procedures are involved, or you are an attendant to a such patient, you are requested to cross check the originality of this product with your healthcare professionals (e.g. physicians, surgeons, gynecologist, anesthesiologist, etc.) to ensure the originality of product.
                      Suspected-Falsified-Product-in-market-Restane-Inhalation-SolnDownload