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DRAP’s Pharmacovigilance Newsletter (December, 2023 ; Issue-II)

Asad Ullah General, Pharmacovigilance

The Pharmacovigilance Newsletter is a quarterly publication that aims to inform and educate the healthcare professionals and the public about the importance of pharmacovigilance and adverse drug reaction reporting. It also showcases the activities of the National Pharmacovigilance Centre (NPC) and initiatives taken by the NPC for monitoring and evaluating the safety of medicines in Pakistan.

We are pleased to announce that the second issue of the Pharmacovigilance Newsletter (Dec-2023) is now available for download from our website. This issue covers the latest updates on the safety of medicinal products and regulatory actions taken by the Drug Regulatory Authority of Pakistan (DRAP) and other international authorities.

NPC Newsletter_Dec23Download

We hope that you will find the newsletter informative and useful. We welcome your feedback and suggestions for improvement. You can contact us at npc∂drap.gov.pk or call us at +92-51-9255980. Thank you for your interest and support in pharmacovigilance.

Together, we can ensure the safe and effective use of medicines in Pakistan.

Recall Alert: Drug Product; Sterile Water for Injection (Batch # B6-77) by ISIS Pharmaceutical & Chemical Works, Karachi

Asad Ullah Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/11-23-43
Action Date8th Dec, 2023
Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
· General Public
Problem / Issue Federal Government Analyst, CDL Karachi has informed DRAP regarding the sample of product namely “Sterile Water for Injection” Batch No. B6-77 manufactured by M/s. ISIS Pharmaceuticals & Chemical works, 25/1-4, Sector 12-C, North Karachi Industrial Area, Karachi, has been declared as of “Substandard” quality.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No Manufacturer
Sterile Water for Injection  
 
 
Reg.No 048819		Sterile Water for InjectionBatch No: B6-77
 
Mfg. Date: August 2023
Exp. Date: August 2025		M/s. ISIS Pharmaceutical
& Chemical Works, Karachi
Risk Statement:Sterile water for injection is a sterile, non-pyrogenic, and isotonic solution of water that does not contain any additives. It is mainly used as a solvent or diluent for other parenteral drugs, such as antibiotics and administered intravenously, intramuscularly, or subcutaneously.

Endotoxin is a toxic substance that can cause serious harm such as fever, inflammation, shock, coagulation, and immune suppression. Using endotoxin-contaminated water for injection can lead to life-threatening complications, especially if injected intravenously.
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) has 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.

    Recall Alert: Drug Product; Dolor DS 100mg/5mL Suspension (Batch # 1236,1237 and 1238) by Adamjee Pharmaceutical, Karachi

    Asad Ullah Recall Alerts

    Recall Alert

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    DRAP Alert NoNo II/S/10-23-42
    Action Date30th Nov, 2023
    Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
    ·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
    · General Public
    Problem / Issue Federal Government Analyst, CDL Karachi has declared the03 Batches of product “Dolor DS Suspension” as of substandard quality.
    The detail of the affected product is as under:

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch No Manufacturer
    Dolor DS Suspension  
     
     
    Reg.No 14451
    		Mefenamic AcidBatch No1236, 1237, 1238
     
    Mfg. Date: March 2023
    Exp. Date: March 2025    		M/s. Adamjee Pharmaceuticals
    (Pvt.) Ltd, Karachi
    Risk Statement:Mefenamic acid is used for the short-term relief of mild to moderate pain from various conditions such as headache, dental pain, menstrual cramps, and muscle aches. Inaccurate use of the product may lead to common side effects like skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

    Impact of use of substandard product on basis of pH test may significantly altered the solubility and interfere with its absorption which may leads to sub optimal therapeutic effect.
     
    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) has 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.

      Decisions of 62nd Meeting of Medical Device Board (Deficiency letter for Medical Devices Applications)

      Asad Ullah Medical Devices Board

      The Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan in its 62nd meeting has deferred the following applications of registration of medical devices due to various deficiencies/shortcomings in the applications dossiers. These applicants are requested to furnish the requisite information/documentation as directed by the Medical Device Board. The detail is provided in the below attachment.

      DEFERRED LETTERS OF M_62Download

      Recall Alert: Drug Product; Piperazine Elixer (Batch # L-085) by Swat Pharmaceuticals, Swat

      Asad Ullah Recall Alerts

      Recall Alert

      Download

      DRAP Alert NoNo II/S/10-23-41
      Action Date20th Nov, 2023
      Target Audience·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores
      ·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics etc.
      · General Public
      Problem / Issue Federal Government Analyst, CDL Karachi has declared the Batch No. L085 of product “Piperazine Elixer” as of substandard quality.

      Therapeutic Good(s) Affected: –

      Product NamesCompositionBatch No Manufacturer
      Piperazine 750mg/5ml Elixir
       
      Reg.No  002235

      		Piperazine CitrateBatch No L-085
       
      Mfg. Date: June 2023
      Exp. Date: May 2025      		Ms. Swat Pharmaceuticals,
      Saidu Sharif Swat.
      Risk Statement:Piperazine Citrate is used to treat common roundworms (ascariasis) and pinworms (enterobiasis; oxyuriasis). To avoid the common side effects of gastrointestinal disturbances, headache, dizziness, and urticaria, it is important to use the product accurately.
      It is critical to ensure that the product is not substandard, as its use can significantly alter the dose and lead to suboptimal therapeutic effects.
       
      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) has 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.