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Drug Safety Alert: Risk of Serious Bowl complications with clozapine

Asad Ullah Safety Alerts, Safety Communication, Safety Info

Drug Safety Alert

Update from Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of Pakistan

Date:18th of November 2022
Target Audience:• Manufacturers and importers of Clozapine;
• Healthcare Professionals; and
• Patients, consumers or caregivers.
BackgroundThe Therapeutic Goods Administration (TGA) of Australia on 22nd, April 2022 through a safety advisory informed that Product Information (PI) and Consumer Medicine Information (CMI) for Clozapine have been updated to strengthen warnings about potential severe gastrointestinal side effects, including constipation. It was informed that Clozapine may also affect the bowels by slowing them down and can cause severe constipation, the condition known as clozapine-induced gastrointestinal hypomotility. If untreated, it can lead to serious problems. Consumers who were using clozapine were informed to look out for changes in their bowel function and to contact their health professionals if they develop any of the symptoms.
On 14th January 2022, the United States Food and Drug Administration (US-FDA) through Drug Safety Podcast referred to the already issued communication dated 18th of February 2020 where the FDA strengthens the existing warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril®) can lead to serious bowel problems. It was informed that serious bowel complications can lead to hospitalization or even death if constipation is not diagnosed and treated quickly.
Action in PakistanAccordingly, the case of risk of serious bowel complications with Clozapine was discussed in the 1st meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of the National Pharmacovigilance Centre (NPC), Division of Pharmacy Services, Drug Regulatory Authority of Pakistan (DRAP) which after detailed deliberation and discussion decided to update and strengthen the warning section of Clozapine with gastrointestinal side effects, including constipation and severe bowel problem in light of Rule 10 (1) (h) (iv) of Pharmacovigilance Rules, 2022 as a part of reliance mechanism on stringent regulatory authorities.
Therapeutic Goods Affected:Clozapine Tablets
Clozapine is a medicine that has been used for more than 40 years to treat schizophrenia in patients whose symptoms are not controlled with standard treatment
Advice for healthcare professionals:Healthcare professionals are advised the following: to evaluate bowel function before starting a patient on clozapine and avoid co-prescribing clozapine with other anticholinergic medicines that can cause gastrointestinal hypomotility; advise patients frequently of the significant risk of constipation and life-threatening bowel issues and the need to stay hydrated to prevent constipation; advise patients to contact a healthcare professional right away if they have difficulty having a bowel movement or passing stools, do not have a bowel movement at least three times a week or less than their normal frequency.
Advice for patients:Patients are advised to contact their healthcare professionals if they have symptoms that can be associated with serious bowel problems such as nausea, vomiting or stomach pain. To prevent constipation, they should eat more fruits, vegetables, and grains that are high in fibre; drink plenty of water and other liquids, and get enough exercise.
Guidelines for reporting Adverse Drug Reactions (ADRs):Both healthcare professionals and patients are requested to report any suspected adverse drug reaction (ADRs) to National Pharmacovigilance Centre, Drug Regulatory Authority of Pakistan through Med Vigilance E-Reporting system available on DRAP website.
Similarly, ADRs can also be reported through MedSafety App that is available for download from App store (for iOS devices) and Google Play (for Android devices).
References:1-Minutes of 1st meeting of Pharmacovigilance Risk Assessment Expert Committee.
2-Safety Advisory- constipation: a potentially serious side effect issued by the Therapeutic Goods Administration of Australia.
3-Drug safety podcast of the United States Food and Drug Administration (US-FDA) regarding constipation caused by schizophrenia medicine clozapine.
22-Safety-Alert-of-Risk-of-Serious-Bowel-Complications-with-Clozapine.Download

Drug Safety Alert: Risk of Anaphylactic Reaction / Anaphylactic Shock with Diclofenac Sodium Injection

Asad Ullah Safety Alerts, Safety Communication, Safety Info

Drug Safety Alert

Update from Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of Pakistan

Date:10th of November 2022
Target Audience:• Manufacturers and importers of Diclofenac Sodium.
• Healthcare Professionals; and
• Patients, consumers or caregiver
Problem or Issue:The National Pharmacovigilance Centre (NPC), Division of Pharmacy Services, Drug Regulatory Authority of Pakistan (DRAP) through the Provincial Pharmacovigilance Centre (PPC), Directorate of Drugs Control Punjab received two serious cases of anaphylactic reactions upon STAT dose administration of injection Diclofenac Sodium 75mg/3ml intramuscular (IM). The cases were reported by Clinical Pharmacy and Pharmacovigilance Officers (CPPOs) of two public sector hospitals in the Punjab province. The diclofenac injection was used in these cases for the wound pain in the left leg and backache. One of the patients has a history of asthma. The symptoms noted were pruritus, erythema, sweating, apprehension and fainting due to a sudden drop in blood pressure, severe shortness of breath, wheezy chest, hypoxia and hypotension. The adverse drug reactions were assessed for causality using the WHO Causality Assessment Criteria and were categorized as “Possible” and “Probable” based on plausible time to onset (same day immediately after administration), positive dechallenge (recovered on withdrawing) and unable to explain from other drugs/ disease.

The case were, therefore, discussed in the 1st meeting of the Pharmacovigilance Risk Assessment Expert Committee (PRAEC) of the NPC, DRAP which decided to update the warning, precaution & contraindication sections of the prescribing information / safety specification / label of Diclofenac Sodium injection about the occurrence of anaphylactic reaction/ anaphylactic shock and its contraindication in a patient with a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
Therapeutic Goods Affected:Diclofenac Sodium injection
Advice for healthcare professionals:Healthcare professionals are informed that Pharmacovigilance Risk Assessment Expert Committee of the DRAP has recommended to update the warning, precaution & contraindication sections of the prescribing information/ safety specification/ label of Diclofenac Sodium injection about the occurrence of anaphylactic reaction/ anaphylactic shock and its contraindication in a patient with a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Therefore, healthcare professionals should know that are rare chances that anaphylactic reactions may occur with diclofenac sodium injection in patients with the aspirin triad or in patients without prior exposure to diclofenac. Immediately discontinue the diclofenac injection if an anaphylactic reaction occurs. Likewise, Diclofenac is contraindicated in patients with a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
Advice for patients:Patients are informed that there are rare chances of the development of anaphylactic reaction/ anaphylactic shock with an injection of diclofenac sodium. Talk to your doctor if you have a history of asthma or urticaria, or if you had previously experienced an anaphylactic reaction/ allergic-type reaction with diclofenac sodium or after taking aspirin or other NSAIDs.
Guidelines for reporting Adverse Drug Reactions (ADRs):Both healthcare professionals and patients are requested to report any suspected adverse drug reaction (ADRs) with Diclofenac Sodium to National Pharmacovigilance Centre, Drug Regulatory Authority of Pakistan through Med Vigilance E-Reporting system available on DRAP website.
Similarly, ADRs can also be reported through MedSafety App that is available for download from App store (for iOS devices) and Google Play (for Android devices).
References:Minutes of 1st meeting of Pharmacovigilance Risk Assessment Expert Committee.
20-Safety-Alert-of-Anaphylactic-reaction-with-Diclofenac-Sodium.Download

Recall Alert: Drug Product; Moxtrex 400mg Tablets (Batch # 850) by M/s Gillman Pharmaceuticals, Hattar, Khyber Pakhtunkhwa

Asad Ullah Product Recalls, Recall Alerts

Recall Alert

DRAP Alert NoNoII/S/10-22-32
Action Date3rd 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 Moxtrex 400mg Tablets,
Active Ingredient(s): Moxifloxacin
Company: M/s Gillman Pharmaceuticals, Hattar.
Batch No. 850
Manufacturing Date: 06-2022
Expiry Date: 06-2024
Problem / Issue Drug Testing Laboratory (DTL) Rawalpindi has analyzed the samples of Moxtrex 400mg Tablets manufactured by M/s Gillman Pharmaceuticals, Hattar, KPK and declared the batch No. 850 as “substandard” based on the analysis report.
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.
    Moxtrex-400mg-TabDownload

    Recall Alert: Drug Product; Ceficure 400mg Capsules (Batch # C-737) by M/s Max Pharmaceuticals Islamabad

    Asad Ullah Product Recalls, Recall Alerts

    Recall Alert

    DRAP Alert NoNoII/S/10-22-30
    Action Date2nd 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 Ceficure 400mg Capsules,
    Active Ingredient(s): Cefixime
    Company: M/s MAX Pharmaceuticals, Islamabad.
    Batch No. C-737
    Manufacturing Date: 06-2022
    Expiry Date: 05-2024
    Problem / Issue The Drug Testing Laboratory (DTL), Rawalpindi has analyzed the sample of batch No. C-737 of Ceficure 400mg Capsule manufactured by M/s. Max Pharmaceutical, Islamabad, and declared it as “misbranded” drug product.
    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.
      Ceficure-cap-Recall-AlertDownload

      Recall Alert: Drug Product; Telsarta 40mg Tablets (Batch # 2B151) by M/s PharmEvo Pharmaceuticals Pvt Ltd. Karachi

      Asad Ullah Product Recalls, Recall Alerts

      Recall Alert

      DRAP Alert NoNoII/S/10-22-31
      Action Date2nd 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 Telsarta 40mg Tablets,
      Active Ingredient(s): Telmisartan
      Company: M/s PharmEvo Pharmaceuticals Pvt, Ltd. Karachi
      Batch No. 2B151
      Manufacturing Date: 02-2022
      Expiry Date: 01-2024
      Problem / Issue Drug Testing Laboratory (DTL) Rawalpindi has analyzed the samples of Telsarta 40mg Tablets manufactured by M/s PharmEvo Pharmaceuticals Pvt Ltd, Karachi and declared the batch No. 2B151 as “substandard” based on the analysis report.
      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.
        Telsarta-AlertDownload

        Suspected Falsified Alert; Drug Products; Suspected Anti-D Immunoglobulin Injection in the market

        Asad Ullah Recall Alerts, Regulatory Updates

        Rapid Alert

        DRAP Alert NoNoI/S/10-22-29
        Action Date28th October 2022
        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 StatementDRAP received a complaint regarding the presence of following suspected product in the market. This product is not imported and marketed by the authorized registration holder and neither DRAP has issued import clearance for this product. National Control Laboratory for Biological has also not issued any lot release to this product.
        SrProduct NameCompositionBatch #Manufactured by (as stated on label)
        101 IMMUNORHO 300µg (1.500iu)
        (PFS; Pre-filled syringe)         		Human anti-D immunoglobulinM05W25212M/s. KEDRION BIOPHARMA.
        Action InitiatedThe Regulatory Field Force has been directed to increase the market surveillance and confiscate this product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this 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 suspected 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 this product 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.
        Pictures of Suspected falsified product
        immunorho-safety-alert-revisedDownload

        Regulatory Update / Advisory; Recall of Targocid 200mg powder for solution for injection/infusion or oral solution in UK

        Asad Ullah News & Updates, Recall Alerts, Regulatory Updates

        Date:   31st October, 2022

        Target Audience: –  

        • Healthcare Professionals- Physicians, Pharmacists, and Nurses.
        • General Public

        Problem or Issue: –

        Sanofi UK has initiated an urgent recall of two batches of Targocid 200mg powder for solution for injection/infusion or oral solution (Batch Number 0J25D1 and Batch Number 0J25D2). Reason for recall is the out of specifications results obtained for bacterial endotoxins in the retained samples.

        However, both of these batches were not imported or marketed in Pakistan by the authorized registration holder company, hence, Pakistan’s market will not be affected by this recall operation.

        Nonetheless, DRAP has directed registration holder company to test the retaining samples of other batches which are supplied in Pakistan to ensure that problem is not extended beyond the identified two batches.  

        Advice for healthcare professional: –

        Healthcare professionals should be aware of the clinical symptoms related to the potential risk to patient health; a high temperature (fever) or low body temperature, chills and shivering, cold, clammy and pale or mottled skin, a fast heartbeat, fast breathing, severe breathlessness, severe muscle pain, feeling dizzy or faint, a change in mental state – such as confusion or disorientation, loss of consciousness, slurred speech, nausea and vomiting and/or diarrhea.

        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.  Further information on how to report a problem to DRAP is available on this link.

        Advice for general public: –

        Since, these affected batches have not been imported or supplied in Pakistan by the marketing authorization holder, no recall is initiated for this product in Pakistan. These these batches were supplied and being recalled in the UK market only. However, if any person has carried these affected batches for their personal use they are advised not to consume it, and consult their healthcare provider immediately.

        ADVISORY-TARGOCID-final-revisedDownload

        Suspected Falsified Alert; Drug Products; Regulatory Field Force reported the presence of suspected falsified products in market

        Asad Ullah Product Recalls, Recall Alerts, Safety Info

        Suspected Falsified Alert

        DRAP Alert NoNoI/S/10-22-28
        Action Date25th October, 2022
        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 StatementDuring the market surveillance activities in different areas of Karachi, Provincial Drug Inspectors from Karachi have identified the suspected samples of products and sent for analysis to Drug Testing Laboratories. The Provincial Drugs Testing Laboratory, Sindh, Karachi has declared the samples of following products as spurious. The stated manufacturers on the labels of these products has informed that they have not manufactured these batches. Details are as under: –
        SrProduct NameBatch #PURPORTED TO BE MANUFACTURED BY
        1Cap Rulling 40mg4RU083M/s. High-Q Pharma Karachi.
        2Cap Eskeem 40mg4EK086-do-
        3Cap Mixel 400mg4MX120-do-
        4Tab Dicloran 50mg002HM/s. Sami Pharma Karachi
        5Inj Meronem IV 1g4A21D282
        4A21H02
        4B21K26        		M/s. ACS Doblar & packed by Ms. Pfizer Pakistan Ltd.
        6Inj. Tanzo 2.25gPN20148M/s. Bosch Pharma Karachi
        7Inj. PENRO 500mgPO210047-do-
        8Tab. Ciproxin 500mgBAA058M/s. Bayer Pakistan Ltd Karachi
        9Cap Azomax 250PMSAM/s. GlaxoSmithKline Ltd.
        10Tab. Relief Extra Finished
        (Packed strips)        		Not mentionedM/s. Combitic Global Caplet, India
        Action InitiatedThe Regulatory Field Force has been directed to increase the market surveillance and confiscate these batches of above-mentioned products. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying these batches of products. The remining 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 above-mentioned batches of 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 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 any these drug products, 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.
        DRAP’s alert on suspected falsified products in market Download

        Drug Impurity Alert ! Compulsory Testing of Solvents Glycerin, Propylene Glycol & Sorbitol used in Oral Preparations for Presence of any Toxic Impurities (e.g. Diethylene Glycol (DEG) & Ethylene Glycol (EG).

        Asad Ullah Safety Alerts, Safety Communication, Safety Info

        Drug Safety Alert

        Date:21st of October 2022.
        Target Audience:• Regulatory Field Force
        • Manufacturers of Glycerin containing formulations to control level of Diethylene glycol and Ethylene glycol
        • Healthcare Professionals- Physicians, Pharmacists, and Nurses
        • General Public
        Problem or Issue:Glycerin, Sorbitol & Propylene glycol are widely used in therapeutic goods as solvents. However, recently there has been report in international media related to the adulteration of these materials with highly toxic Diethylene Glycol (DEG) and Ethylene Glycol(EG). These impurities, DEG and EG are poisonous and may lead to severe health injury or death, as recently reported in Gambia, and also being associated with the incident happened in Indonesia due to consumption of syrups containing glycerin. These reports warrant an emergent need of extraordinary measures and vigilant monitoring of these possible contaminants.
        Potential Hazards linked to DEG and EG:Toxic effects can include abdominal pain, diarrhea, inability to pass urine, headache, altered mental state, vomiting and acute kidney injury which may lead to death especially in children
        Advice for healthcare professionals:DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities to detect any substandard / falsified product in the market. 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 Manufacturer’s and Importers of Products containing Glycerin Solvent:Perform test/analysis of for presence of any toxic impurity/contaminants specially when used in oral dosage forms such as syrups/suspensions etc. It is legal responsibility of all manufacturers of therapeutic goods to ensure before marketing that all the manufactured therapeutic goods are safe for consumption. Therefore, it is required that all manufacturers using these solvents must perform proper testing to detect DEG and EG contamination
        Advice for General Public: 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.
        Guidelines for reporting Adverse Drug Reactions (ADRs):Both healthcare professionals and patients are requested to report any adverse events they have experienced to National Pharmacovigilance Centre, Drug Regulatory Authority of Pakistan through DRAP Med Vigilance E-reporting system or at npc∂dra.gov.pk.

        Similarly, adverse events can also be reported through Med Safety Mobile Application that is available for download from the App store (For iOS devices) and Google Play (For Android devices).
        References:

        DRAP has issued alerting note to all relevant stakeholders for taking effective measures in this regard.

        Important-Drugs-Impurity-Alert-21-oct-2022Download

        Recall Alert: Drug Product; Sterile Water for Injection (Batch # 440) By M/s. Karachi Pharmaceutical Laboratories, Karachi

        Asad Ullah Product Recalls, Recall Alerts

        Recall Alert

        DRAP Alert NoNoI/S/10-22-29
        Action Date20th October, 2022
        Target Audience1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
        2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions
        3. General Public
        Product(s) Affected Sterile Water for Injection,
        Company: M/s. Karachi Pharmaceutical Laboratories, Karachi
        Batch No. 440
        Manufacturing Date: June-2022,
        Expiry Date: June-2025
        Problem StatementThe Central Drug Laboratory Karachi has analyzed the sample of Sterile Water for Injection (Registration No. 012570) bearing Batch No. 440, and declared it as Substandard. The company has been directed to recall the affected batch of product from the market.
        Action to be taken-All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the 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) 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 healthcare institutions and hospital pharmacies.

        -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 if they have experienced any problems that may be related to taking or using this drug product.

        All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt.
          DRAP’ Recall Alert on WFI-Karachi-Pharmaceutical-LabDownload