Home > 2023 > September

Month: September 2023

Recall Alert: Drug Product; Comycetin 0.5% Eye Drops (Batch # CYF003) by M/S. Nabiqasim Industries (Pvt) Ltd., Karachi

Asad Ullah Recall Alerts

Recall Alert

Download

DRAP Alert NoNo II/S/08-23-33
Action Date18th Sep, 2023
Target Audience· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses.
· Procurement Officers at Hospitals and Healthcare Institutions.
· Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
Problem / Issue

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
Comycetin 0.5% Eye Drop
 
Reg No. 003682

ChloramphenicolBatch No CYF003
 
Mfg date 02.2023
Exp date 02.2025		Ms. Nabiqasim Industries
(Pvt.) Ltd., Karachi
Risk Statement:Chloramphenicol is used to treat bacterial eye infections. The impact of use of the substandard product may lead to sub-optimal to no therapeutic effect and may intensify/flare the existing bacterial infection along with the development of Bacterial resistance.
Action Initiated-The manufacturer has been directed to immediately recall the defective 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 quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s).

-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 ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

-Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the 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). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.

-All therapeutic 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.

    FIFO Applications List for the Provisional Enlistment of Alternative Medicines and Health Products

    Ijaz Mustafa Alternative Medicines, General

    The Division of Health & OTC (non-drugs) is responsible for performing the enlistment of manufacturers, importers and their products under the Alternative Medicines and Health Product (Enlistment) Rules 2014.

    The Division of Health & OTC, DRAP has published FIFO lists of applications received for the provisional enlistment of various categories of alternative medicines and health products. These lists contain the details of the applicants, the proposed name of the products and date of submission of application.

    These lists are intended to provide transparency and accountability to the stakeholders and the public regarding the processing of the applications. It also aims to facilitate the applicants to follow up on their applications.

    The list of pending applications can be accessed from the following link:

    Applications list for H&OTC Products

    Recall Alert: Drug Product; Kemygyl 200mg/5mL oral Suspension (Batch # M-319) by M/s. Alkemy Pharmaceutical Laboratories (Pvt) Ltd, Hyderabad

    Asad Ullah Recall Alerts

    Recall Alert

    Download

    DRAP Alert NoNo II/S/08-23-31
    Action Date08th Sep, 2023
    Target Audience· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses.
    · Procurement Officers at Hospitals and Healthcare Institutions.
    · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
    Problem / Issue The Provincial Government Analyst/Director, Drug Testing Laboratory, Karachi has declared the Batch No. M-319 of Kemygyl Suspension as of substandard quality sampled by Provincial Inspector of Drugs Jamshoro.

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch No Manufacturer
    Kemygyl Suspension 200mg/5ml

    		MetronidazoleBatch No M-3019
     
    Mfg date 09.2022
     
    Exp date 08.2024    		Ms. Alkemy Pharmaceutical Laboratories (Pvt.) Ltd, Hyderabad.
    Risk Statement:Metronidazole Oral Suspension is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or suspected. Use of substandard products may lead to suboptimal to no-therapeutic effects and may contribute to drug resistance, and can also intensify/exacerbate the existing bacterial infection.
    Action Initiated-The manufacturer has been directed to immediately recall the defective 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 quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s).

    -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 ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

    -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the     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). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.

    -All therapeutic 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.

      Rapid Alert; Drug Product: Falsified Defitelio 80mg/mL Injection identified in Neighboring Countries

      Asad Ullah Recall Alerts
      Download

      Rapid Alert

      Falsified Defitelio 80mg/mL Injection
      (Updated form WHO)

      DRAP Alert NoNo  I/S/09-23-44
      Action DateSeptember 08, 2023
      Target Audience1. Regulatory Field Force.
      2. Healthcare Professionals – Physicians, Pharmacists, and Nurses.
      3. General Public.
      Problem StatementWHO has informed regarding the presence of a falsified batch of DEFITELIO (defibrotide sodium) Lot No. 20G20A detected in India (April 2023) and Türkiye (July 2023) and was supplied outside of regulated and authorized channels. This product is not registered in Pakistan however, due to its detection in the neighboring countries, it is highly likely that this product can infiltrate the Pakistani market.
      DEFITELIO (defibrotide) is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstructive syndrome (SOS) in hematopoietic stem-cell transplantation (HSCT) therapy. It is indicated for adults, adolescents, children and infants over 1 month of age. VOD is a condition in which the veins in the liver become blocked and stops the liver from working correctly.
      The genuine manufacturer of DEFITELIO has confirmed that the product referenced in this Alert is falsified. The genuine manufacturer has advised that:
      ·         Genuine DEFITELIO with Lot 20G20A was packaged in German/Austrian packaging.
      ·         The falsified products instead are in UK/Ireland packaging.
      ·         The stated expiry date is falsified and does not comply with the registered shelf life.
      ·         The stated serial number is not associated with batch 20G20A.
      ·         DEFITELIO does not have marketing authorization in India and Türkiye.

      Therapeutic Goods Affected:-

      SrProduct NameCompositionBatch/Lot #Mfg. DateExp. DateManufactured by
      (as stated on label)
      1DEFITELIO 80 mg/mL concentrate for solution for infusion
      		Defibrotide20G20A—Aug-2024Gentium Srl
      (UK/ Ireland packaging)
      Threats to Public HealthThe use of falsified DEFITELIO will result in the ineffective treatment of patients and may pose other serious risks to health because of its intravenous administration and could be life-threatening in some circumstances. Moreover, the safety, sterility, and quality of the falsified products referenced in this alert are also unknown.
      Action InitiatedThe Regulatory Field Force has been directed to increase surveillance throughout the supply chain system including healthcare facilities to confiscate/seize this product from the market without any delay. Since this product is not registered with DRAP, it is not permitted to be stocked or sold in pharmacies or other retail outlets. However, it is crucial for all healthcare professionals, including pharmacists and chemists, to check their stock immediately and stop the distribution or supply of this product if it is found. Information related to the supplier of this product should be provided to the Regulatory field force (DRAP, Provincial Health Departments, and States) to ensure the removal of this product.
      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 the above-mentioned 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 ConsumersConsumers should not use this product and shall contact their physician or healthcare provider if they have experienced any problem related to taking or using this drug product and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre.

      All therapeutic goods must be obtained from 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 Defiiteli 80mg/mL injection identified as falsified Product

      Pictures of Falsified Defitelio 80mg/mL Injection identified in Türkiye

      Recall Alert: Drug Product; Plivil 25mg Injection (Batch # 847) by M/s. Pliva Pakistan, (Pvt) Ltd, Baluchistan

      Asad Ullah Recall Alerts

      Recall Alert

      Download

      DRAP Alert NoNo I/S/08-23-22
      Action Date06th Sep, 2023
      Target Audience· Healthcare Professionals particularly working in hospitals; Physicians, Pharmacists, and Nurses.
      · Procurement Officers at Hospitals and Healthcare Institutions.
      · Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores.
      Problem / Issue The Secretary, PQCB Baluchistan has informed DRAP that samples of Plivil Injection (Batch No. 847) manufactured by M/s. Pliva Pakistan (Pvt.) Ltd., B-77, Lasbella Industrial Estate, Baluchistan, has been analyzed by the Government Analyst, Drug Testing Laboratory (DTL), Baluchistan, Quetta and declared as Adulterated and misbranded based on analysis.

      Therapeutic Goods Affected:-

      Product NamesCompositionBatch No Manufacturer
      Plivil 25mg/ml Injection

      Reg No 021513      		Pheniramine Maleate
      25mg/ml      		Batch No 847
       
      Mfg date 02.2023
       
      Exp date 02.2025      		M/s. Pliva Pakistan (Pvt.) Ltd., Baluchistan.
      Risk Statement:Presence of foreign particles may interact within the injectable solution and may change the chemical consistency of the solution. If injected, they can cause inflammation, tissue damage, or allergic or immunogenic reactions. Additionally, unclear labels on the drug products may create difficulty in reading and understanding of drugs and may lead to medication errors such as taking the wrong medication or the wrong dose.
      Action Initiated-The manufacturer has been directed to immediately recall the defective 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 quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s).

      -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 ProfessionalsDRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product.  

      -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the       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). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product.

      -All therapeutic 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.