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Recall Alert: Drug Product; Opth-Carb Sterile Intraocular Solution (Batch#OP154) by M/s Opth Pharma (Pvt) Ltd., Karachi.

Asad Ullah Recall Alerts

Recall Alert

DRAP Alert NoNoI/S/03-23-16
Action Date9th March 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 Ophth-Carb Sterile Intraocular Solution
Manufactured by: M/s. Ophth Pharma (Pvt.) Ltd., Karachi
Batch No. OP154
Manufacturing Date: 12-2022
Expiry Date: 11-2024
Problem / Issue Federal Government Analyst, CDL Karachi has declared the Batch No. OP154 of product “Ophth-Carb Sterile Intraocular Solution” as of substandard quality.
Risk StatementCarbachol is primarily used in the treatment of glaucoma, it is also used during ophthalmic surgery. All ophthalmic products must meet a number of requirements of safety and sterility and if the product is not sterile (free from bacteria or microorganisms), it may lead to serious infection which includes but not limited to redness of eyes, itching in eyes, watery discharge, blurred vision and loss of vision.
Action Initiated-The sole agent / 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 batch of product. The remaining stock should be quarantine and return to the supplier / 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.
    Opth-Carb-Intraoculat-Soln-Recall-AlertDownload

    Safety Alert: WHO Global Alert on Tetracycline Hydrochloride Ophthalmic Ointment USP 1%

    Asad Ullah Recall Alerts, Regulatory Updates, Safety Alerts

    Safety Alert

    Update from WHO Global Surveillance and Monitoring System

    Date:28th February 2023
    Target Audience:· Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc.
    · International travelers/General Public
    · NGO’s/Supply Donations/Humanitarian Medicines
    Problem or IssueWorld Health Organization (WHO) issued Medical Product Alert No. N°2/2023 dated 22nd February 2023 which refers to the batches of Tetracycline Hydrochloride Ophthalmic Ointment USP 1%, manufactured by Galentic Pharma (India) Pvt. Ltd, located at R-673, T.T.C. MIDC Rabale, Thane- Belapur Road, Navi Mumbai – 400701, Maharashtra, India Supplied in various countries under various labels.
    Visual examination of random samples had shown a range of quality issues with the random samples of the product batches e.g. particles ranging in color, size and shape on the nozzle, in the cap and in the ointment inside each tube, black spots and brown splotches on the inner foil layer of the tube, and phase separation.
    DRAP has never authorized sale of any products from Galentic Pharma (India) Pvt. Ltd (Thane Belapur Road, Navi Mumbai, India). These products are neither registered nor available on Pakistan market, however these may have been carried for personal use while visiting other countries.
    The manufacturer has initiated a voluntary recall for several batches. The manufacturer has indicated that other batches may be included in the voluntary recall
    Potential Hazards:There is currently no established evidence of any adverse events from the affected batches of TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1%. Redness and swollen eyes are common reactions to general use of tetracycline eye ointment. There is currently no indication that the above-mentioned quality issues may give rise to adverse events that are not listed in the product labelling. The affected TETRACYCLINE HYDROCHLORIDE OPHTHALMIC OINTMENT USP 1% is supplied in bulk and as a component of various medical kits supplied by some international organizations providing humanitarian assistance.
    Advice for healthcare professionals:DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this affected batch of product. Adverse reactions or quality problems experienced with the use of any product shall be reported to the National Pharmacovigilance Centre(NPC), DRAP using Adverse Event Reporting Form or online through this link.  Further information of reporting problems to DRAP is available on this link.
    Advice for patients:Consumers should stop using this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, and report the incident to Drug Regulatory Authority of Pakistan/ National Pharmacovigilance Centre.
      Safety-Alert-for-TetracyclineDownload

      All therapeutic goods must be obtained from the licensed pharmacies, and other authorized retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professional in case of any doubt.

      Recall Alert: Drug Product; Oscal-D Tablets (Batch # 6904) by M/s Aries Pharmaceuticals (Pvt) Ltd, Peshawar.

      Asad Ullah Recall Alerts

      Recall Alert

      DRAP Alert NoNoI/S/02-23-14
      Action Date24th 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 Oscal-D Tablets
      Manufactured by: M/s. Aries Pharmaceuticals (Pvt) Ltd, Peshawar.
      Batch No. 6904
      Manufacturing Date: 07-2022
      Expiry Date: 07-2024
      Problem / Issue Federal Government Analyst, CDL Karachi has declared the Batch No. 6904 of product “Oscal-D Tablets” as of substandard quality.
      Risk StatementOscal-D Tablets may be used to treat conditions caused by low calcium levels such as osteoporosis, osteomalacia/rickets, hypoparathyroidism and latent tetany. Inaccurate use of the product may lead to adverse reactions including but not limited to irregular heartbeat, weakness, drowsiness, headache, dry mouth or a metallic taste in your mouth or muscle or bone pain. Impact of use of substandard product on basis of assay test may leads to low to no therapeutic effect etc.
      Action Initiated-The sole agent / 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 batch of product. The remaining stock should be quarantine and return to the supplier / 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.
        Recall-Alert-Oscal-D-tabletsDownload

        Recall Alert: Drug Product; Calcium Gluconate Injection (Batch # 220325) by M/s Shaheen Agency Karachi

        Asad Ullah Recall Alerts

        Recall Alert

        DRAP Alert NoNoI/S/02-23-11
        Action Date23rd 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 Calcium Gluconate Injection
        Company: Importer Name; M/s. Shaheen Agency, Karachi , Manufactured by: M/s. China National M/H Shanghai China
        Batch No. 220325
        Manufacturing Date: 03-2022
        Expiry Date: 03-2025
        Problem / Issue Drug inspector Quetta took the sample of Calcium Gluconate Injection Batch no. 220325 which has declared as Misbranded by Provincial Drug Testing Laboratory, Quetta. Details of the product is given as under:
        Risk Statementinjection Calcium gluconate is a lifesaving drug which is indicated for pediatric and adult patients for the treatment of acute symptomatic hypocalcemia. Wrongful use /misleading information due to delible printing upon label of Injection Calcium Gluconate, may disturb the patient’s body calcium balance and may lead to adverse reactions including but not limited to following:
        (i) Arrhythmias with Concomitant Cardiac Glycoside Use.
        (ii) End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates.
        (iii) Tissue Necrosis and Calcinosis.
        (iv)Hypotension, Bradycardia, and Cardiac Arrhythmias.
        Action Initiated-The sole agent / 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 batch of product. The remaining stock should be quarantine and return to the supplier / 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.
          Calcium-Gluconate-Inj-Shaheen-Agency-Recall-AlertDownload

          Recall Alert: Drug Product; Chloroquine Injection (Batch # 201238) by M/s Mehran International Karachi

          Asad Ullah Recall Alerts

          Recall Alert

          DRAP Alert NoNoI/S/02-23-12
          Action Date23rd 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 Chloroquine Injection
          Company: Importer Name; M/s. Mehran International, Karachi , Manufactured by: M/s. Shanxi Shuguana Pharma Co Ltd, China
          Batch No. 201238
          Manufacturing Date: 12-2020
          Expiry Date: 12-2023
          Problem / Issue Drug inspector Quetta took the sample of Chloroquine 5ml Injection Bach No. 201238 which has declared as Misbranded by Provincial Drug Testing Laboratory, Quetta.
          Risk StatementChloroquine is used to prevent and treat of Malaria and Amebiasis. Improper labels due to delible printing of label may lead to misleading information, accidentally administering the wrong medication or wrong dose, may cause a patient to experience a negative health outcome. Further it may lead to adverse reactions including but not limited to Allergic reactions, Cardiac effects, Nausea, Vomiting, Abdominal cramps, Headache, and Diarrhea.
          Action Initiated-The sole agent / 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 batch of product. The remaining stock should be quarantine and return to the supplier / 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.
            Recall-Alert-Chloroquine-InjDownload

            Rapid Alert: Falsified / Spurious Cilapen 500mg Injection identified in the market

            Asad Ullah Recall Alerts

            Rapid Alert

            Falsified / Spurious Cilapen 500mg Injection

            DRAP Alert NoNoI/S/02-23-13
            Action Date21st February 2023
            Target Audience1. Regulatory Field Force
            2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
            3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions
            4. General Public
            Problem StatementFederal Inspector of Drugs Karachi took the sample of Cilapen 500mg Injection and sent to Central Drug Laboratory, Karachi for test/analysis. Federal Government Analyst has declared the sample as Spurious under section 3(z-b) (ii) of the Drugs Act 1976.

            The product detail as mentioned on the label is as under: –

            Therapeutic Goods Affected:-

            SrProduct NameComposition as per labelBatch #Manufactured by (as stated on label)
            1Cilapen 500mg Injection

            Mfg. Date: 06-2022
            Exp. date:  03-2024            		Imipenem + CilastatinCP19014Ms. Bosch Pharmaceuticals (Pvt.) Ltd., Karachi.

            Following is the comparison of sample against the original pack of the product: – 

            S.NDescriptionOriginal pack of the manufacturer (Bosch)Sample pack (Spurious/Falsified)
            1Batch number for vialCP19014CP19014
            2Manufacturing date11-201806-2022
            3Expiry date10-202003-2024
            4M.R.PRs.810.90/=Rs.1,140/=
            5Batch number of WFI on the ampoule and cartonBoth same as WI19085WI21042 on the ampoule where as WI19085 on the carton
            6Color of WFI ampouleBlueOrange
            7Printing of descriptions of productOver-printing batch no. manufacturing date and expiry datePlain printing (pre-printing)
            8Font size and styleAs per standard approved Bosch Artwork.Different from the company.
            9Direction insert/leafletAs per standard approved Bosch Artwork.Paper size and quality, color, printing is totally different from that of the company.
            Risk Statement:Imipenem and Cilastatin injection is used to treat certain serious infections that are caused by bacteria, including endocarditis and infection of respiratory tract, urinary tract, abdominal, gynecological, blood, skin, bone, and joint. Wrongful use / misleading information as mentioned above may leads to adverse reactions including but not limited to following:
            ·         Severe stomach pain, diarrhea that is watery or bloody.
            ·         Upper stomach pain, loss of appetite.
            ·         Jaundice and fever.
            ·         Seizure; light-headed feeling, like you might pass out.

            Consequences of use of Falsified/Spurious Drugs are:
            ·   Falsified/Spurious drugs may contain toxic doses of dangerous ingredients and cause mass poisoning.
            ·   Contributes to the progression of antimicrobial resistance and drug-resistant infections.
            ·   Poor-quality medicines compromise the treatment of chronic and infectious diseases, causing disease progression, drug resistance, and death.
            Action InitiatedThe Regulatory Field Force has been directed to increase the surveillance activities in the market to confiscate this batch of product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this batch product. The remaining stock should be quarantine 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 within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned products.

            -Adverse reactions or quality problems experienced with the use of these 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-Consumers should STOP using these products and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, and report the incident to Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

            -All therapeutic goods must be obtained from the licensed pharmacies, and other authorized / licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.
            Rapid-Alert-Cilapen-500mg-InjectionDownload

            Recall Alert: Drug Product; Hydralazine 25mg Tablets (Batch # 257) by M/s Zafa Pharmaceuticals (Pvt) Ltd, Karachi .

            Asad Ullah Recall Alerts ,

            Recall Alert

            DRAP Alert NoNoI/S/02-23-12
            Action Date21st 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 Hydralazine 25mg Tablets
            Active Ingredient(s): Hydralazine
            Company: M/s. Zafa Pharmaceuticals (Pvt) Ltd, Karachi.
            Batch No. 257
            Manufacturing Date: 10-2022
            Expiry Date: 10-2027
            Problem / Issue CDL Karachi has declared the batch No. 257 of Hydralazine 25mg Tablets, manufactured by M/s. Zafa 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 should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantine and return to the supplier / 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.
              Hydralazine-25mg-Tab-Zafa-Recall-AlertDownload

              Rapid Alert: Urgent Recall of Suspected Products for Contamination of DEG / EG

              Asad Ullah Product Recalls, Recall Alerts, Safety Info , , , , , , ,

              Rapid Alert

              Urgent Recall of Suspected Product for contamination of DEG / EG

              DRAP Alert NoNoI/S/02-23-8
              Action Date20th February 2023
              Target Audience1. Regulatory Field Force
              2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
              3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions
              4. General Public
              Problem StatementMedical Control Agency, Gambia has issued a Safety Alert Ref: – MCA/AD/23/MJK(029) dated 13th February,2023 for KOF Relief Syrup bearing Batch# L394, manufactured by M/s Davis Pharmaceutical Laboratories, Islamabad-Pakistan due to presence of Ethylene Glycol (EG) at unacceptable levels. DRAP Inspectorate has initiated the investigation based on this information, and decided to recall all the suspected products manufactured by the firm using the same source of excipient i.e Glycerin and Propylene Glycol (PG).

              The details of suspected contaminated products are as under: –

              Therapeutic Goods Affected:-

              SrProduct NameCompositionBatch #Manufactured by (as stated on label)
              1Bromgen Syp 100mL

              (Reg. Export Only)              		Bromhexine HClL392M/s Davis Pharmaceutical Laboratories,
              Islamabad-Pakistan
              2Kof Relief Syp 100mL
               
              (Reg, Export Only)              		Chlorpheniramine Maleate
              Ammonium Chloride
              Sodium Citrate
              Menthol
              Green Banana Flavour              		L394-do-
              3Macofen Syp 100mL
               
              (Reg, Export Only)              		IbuprofenL395-do-
              4Vomitil Suspension 120mL

              (Reg, Export Only)              		DomperidoneL400, L408,
              L414,              		-do-
              5Asperfin Syp 60mLKetotifenL401-do
              6Davis Tonic Syrup
              (250mL, 120ml)              		Vitamin B12
              Vitamin B1 HCl
              Vitamin B2
              Vitamin B6
              Vitamin B3
              Folic Acid
              Vitamin B5
              Sodium Glycerophosphate
              Manganese Sulphate
              Ferric Ammonium Citrate              		CS07, CS20,
              CS21, CS23,
              CS30, CS31,
              CS42, CS70,
              CS71, CS159              		-do-
              7Zinc Syp 60mLZinc Sulphate MonohydrateCS06, CS36,
              CS37, CS38,
              CS39, CS45,
              CS46, CS47,
              CS48, CS60,
              CS75, CS76,
              CS80, CS81,
              CS83, CS92,
              CS93              		-do-
              Action InitiatedThe manufacturing company has been directed to immediately recall the suspected batches of these products from the market. All Pharmacists and chemists working at distributions and Pharmacies should immediately check their stocks and stop supplying these batches of products. The remaining stock should be quarantine and return to the supplier / company. Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s).
              Advice for Healthcare Professionals-DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by these batches of above-mentioned products.

              -Adverse reactions or quality problems experienced with the use of these 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-Consumers should STOP using these products and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, and report the incident to Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

              -All therapeutic goods must be obtained from the licensed pharmacies, and other authorized / licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.
              Davis-Rapid-Alert-of-Suspected-Contaminated-ProductsDownload

              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.
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