Home > 2023 > February

Month: February 2023

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

        Proposed Amendments in the Rules: Stakeholders Comments are invited on Draft Amendments in the Drugs (Research) Rules, 1978

        Asad Ullah Drugs, Notifications , , ,

        The Drug Regulatory Authority of Pakistan (DRAP) has issued a proposal to amend the current version of the Drugs (Research) Rules, 1978. These draft amendments are herby notified seeking comments from stakeholders.

        Stakeholders can submit their comments within 14 (fourteen) days of the publication of this Notification using prescribed format, via email to aamar.latif∂dra.gov.pk, or can be posted at mailing address, Additional Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad. Further information on comments submission can be accessed on this link.

        Notification-of-Draft-Amendments-in-the-Drug-Research-Rules-1978-1Download

        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