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Year: 2023

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

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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

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    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.

      Recall Alert; Drug Product: Recall of Liquid Preparations for Suspected Contamination of DEG/EG Impurities by M/s Pharmix Laboratories, Lahore

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      DRAP Alert NoNo I/S/11-23-40
      Action Date16th November 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 DRAP has issued a recall of certain batches of liquid preparations due to suspected contamination with diethylene glycol (DEG) and ethylene glycol (EG).
      WHO has also informed the suspected presence of DEG/EG impurities in batch No. B220 of Alergo Syrup, (identified in the Maldives) which was manufactured by M/s. Pharmix Laboratories (Pvt.) Ltd., Lahore.
      Following a preliminary investigation conducted by DRAP Lahore, it is suspected that these impurities may also be present in other batches and products mentioned below. This recall is a precautionary measure taken to safeguard public health against the potential harmful effects of these impurities

      Therapeutic Good(s) Affected: –

      Product NamesBatch No Manufacturer
      Mucorid Syrup

      		A230, C227, A211, A212,
      B201, L111, A210, A230,
      B224, L121, C210, B201,
      B225      		M/s. Pharmix Laboratories (Pvt.) Ltd.,
      21-Km Ferozpur Road, Lahore.
      Ulcofin SuspensionB209, C223-do-
      Alergo syrupB220, L126do-
      Emidone SuspensionB227do-
      Zincell SyrupC218do-
      Risk Statement:Between 2022 and 2023, several countries reported incidents of oral liquid drugs that were intended for children and were found to be contaminated with high levels of DEG and EG. These incidents lead to severe adverse events and fatalities in few countries.
      Action Initiated-The manufacturing company has been directed to immediately recall the defective batches of the above-mentioned products from the market. All pharmacists and chemists working at distributions and pharmacies are hereby advised to immediately check their stocks and stop supplying these batches of suspected products. The remaining stock should be quarantined and returned to the supplier/ company.

      -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; Weena Syrup (Batch # L-090) by Swat Pharmaceuticals, Swat

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        DRAP Alert NoNo II/S/10-23-39
        Action Date6th 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. L090 of product “Weena Syrup” as of substandard quality.

        Therapeutic Good(s) Affected: –

        Product NamesCompositionBatch No Manufacturer
        Weena Syrup
         
        Reg.No  003049

        		Ferrous sulfate and ascorbic acidBatch No L-090
         
        Mfg. Date: May 2023
        Exp. Date: Apr 2025        		Ms. Swat Pharmaceuticals,
        Saidu Sharif Swat.
        Risk Statement:Ferrous sulphate and ascorbic acid are used to treat and prevent iron deficiency anemia, as well as in prophylaxis for iron deficiency. Incorrect usage of the product can lead to common side effects, including various types of gastrointestinal distress such as nausea, diarrhea, vomiting, abdominal pain, constipation, and dark or discolored stool.
        The use of substandard products may significantly alter the dose, which can 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.

          Recall Alert: Drug Product; Zolan 200mg/5ml Suspension (Batch # L-083) by Swat Pharmaceuticals, Swat

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          DRAP Alert NoNo II/S/10-23-35
          Action Date4th Oct, 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. L083 of product “Zolan suspension” as of substandard quality.

          Therapeutic Good(s) Affected: –

          Product NamesCompositionBatch No Manufacturer
          Zolan 200mg/5mL Suspension
           
          Reg.No  027683

          		Metronidazole benzoateBatch No L-083
           
          Mfg. Date: May 2023
          Exp. Date: Apr 2025          		Ms. Swat Pharmaceuticals,
          Saidu Sharif Swat.
          Risk Statement:Metronidazole benzoate oral suspension is commonly used to treat bacterial infections and intestinal parasites. Inaccurate use of the product may lead to common side effects like nausea, vomiting, diarrhea, and abdominal discomfort; more severe reactions, such as convulsive seizures and peripheral neuropathy, may also occur.
           
          The impact of the use of substandard products on the basis of noncomplying pH may significantly alter the stability, and solubility of the product and may interfere with its absorption which could lead 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.