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Recall Alert: Drug Product; Recall of Contaminated Liquid Preparations

Asad Ullah Recall Alerts

Recall Alert

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DRAP Alert NoNo I/S/01-24-05
Action Date30th January 2024
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 Government Analyst DTL Bahawalpur and DTL Rawalpindi have informed that following products are found to be of “sub-standard” quality due to presence of Ethylene Glycol (EG) impurity at unacceptable levels. Details of affected products is provided in table below.

Therapeutic Good(s) Affected: –

Product NamesCompositionBatch No ManufacturerTest Results
Asthanil 60ml Syp
Ketotifen 1mg/5ml03-23M/s. Siza International (Pvt.) Ltd
18-Km Ferozpur Road, Lahore.		Ethylene Glycol: 2.896%
Does not comply
Virol Syrup
Ribavirin 5mg/5ml35080M/s. Raazee Therapeutics (Pvt.) Ltd.,
48-Km Lahore-Kasur Road, Lahore.		Ethylene Glycol: 3.31%
Does not comply
Torax DM Syrup
Dextromethorphan HBr 12.5mg & Diphenhydramine HCl 12.5mg110-23M/s. Siza International (Pvt.) Ltd.,
18-Km Ferozpur Road, Lahore.		Ethylene Glycol: 2.14%
Does not comply
Texcol EX Syrup
Acefylline Piperazine 45mg, Diphenhydramine HCl 8mg63833M/s. Raazee Therapeutics (Pvt.) Ltd., 48-Km Lahore-Kasur Road, Lahore.Ethylene Glycol: 0.985%
Does not comply
Texcol DM Syrup
Dextromethorphan HBr 10mg/5ml09953M/s. Raazee Therapeutics (Pvt.) Ltd., 48-Km Lahore-Kasur Road, Lahore.Ethylene Glycol: 1.19%
Does not comply
Allerphene Syrup
Chloepheniramine Maleate 2mg/5ml3002M/s. PDH Pharmaceuticals (Pvt.) Ltd., 19-Km Ferozpur Road, Lahore.Ethylene Glycol: 1.417%
Does not comply
Speczine Syrup
Promethazine HCl 5mg/5ml276M/s. Spectrum Laboratories (Pvt.) Ltd., 8-Km Raiwind Road, Lahore.Ethylene Glycol: 2.43%
Does not comply
Bronyl syrup


Nutraceutical cough preparationBL-013M/s. Florex Pharma Pvt Ltd, 25-Km Lahore-Jaranwala Road, Sheikhupura-Lahore.Ethylene Glycol: 0.12%
Does not comply
Action Initiated-All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. 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.

    Warning To Therapeutic Goods Manufactures on DEG/EG Impurities in Raw Materials: A Serious Threat to Therapeutic Goods Quality and Safety

    Asad Ullah Recall Alerts, Regulatory Updates

    The Drug Regulatory Authority of Pakistan (DRAP) has issued a warning to the therapeutic goods industry about the use of raw material contaminated with diethylene glycol (DEG) and ethylene glycol (EG) impurities, which can pose serious health risks to consumers.

    What is the issue?

    The Central Drugs Laboratory Karachi has declared another sample of raw material i.e. propylene glycol (PG) as substandard sent for test/analysis due to unacceptable levels of ethylene glycol.

    Propylene glycol, sorbitol and glycerin are used as solvents in the manufacturing of oral liquid preparations in the pharmaceutical and alternative medicines industry. When used in oral liquid preparations, these solvents can lead to serious health risks due to DEG and EG toxicity. When ingested, DEG and EG are metabolized into toxic metabolites that can affect the central nervous system, heart, and can cause kidney damage, which can be fatal.

    In the past two years, there have been international reports related to the adulteration of these raw materials with DEG and EG causing kidney damage and death of children in Gambia, Uzbekistan, and Indonesia. Industrial grade DEG and EG are used for various applications (solvents, antifreeze agent) in other industries.

    Earlier, several cases of substandard raw materials including PG and finished goods contaminated with DEG and EG have been reported from various part where investigations have suggested that the main problem lies with the integrity of supply chain of raw material which appears to be compromised. Consequently, action has been initiated against the culprits involved.

    What are the actions taken by DRAP?

    Despite repeated warnings and instructions, many therapeutic goods manufacturers have neglected to verify the quality and safety of their raw materials from authorized vendors. The Central Drug Laboratory, Karachi is currently analyzing both raw materials and finished products for EG and DEG contamination, following the pharmacopoeial standards and WHO guidelines for testing of EG and DEG in oral liquid preparations. To ensure the quality and safety of their products, manufacturers should test their raw materials for EG and DEG contamination before using them in their production processes to prohibit potential influx of contaminated products in the market.

    In view of the criticality of the matter and potential for untold human tragedy, the therapeutic goods industry is once again warned to screen raw materials (propylene glycol, glycerin and sorbitol) for contamination with EG and DEG before using these materials in the manufacturing of oral liquid preparations. Additionally, all finished products must be analyzed for EG and DEG contamination before their release into the market. DRAP also issued directives to nutraceutical and alternative medicine companies to ensure compliance and safeguard public health from contaminated products. Additionally, the industry is diected to recall any finished products that were manufactured using the contaminated lot/batch of propylene glycol, hold the affected batches of finished products and ensure testing of finished products for EG and DEG contamination before releasing them into the supply chain.

    DRAP urge pharma industry to take measures to prevent utilization of contaminated raw material in the manufacturing of liquid preparation including following:-

    • Implement a supplier qualification and verify the compliance of the suppliers with the relevant standards and regulations.
    • Verify traceability and authenticity of the raw material using unique identifiers such as barcodes or RFID tags to track their movement and origin throughout the supply chain.
    • Conduct regular risk assessments and monitor the performance of the suppliers, and take corrective actions if any issues are detected.
    • Educate and train the staff and the suppliers on the importance of preventing EG and DEG contamination, and the potential consequences of using contaminated solvents.
    • Verify the features that indicate the authenticity of the product, such as holograms, serial numbers, watermarks, or special packaging. The products should also be checked for any signs of poor printing, misspellings, inconsistent logos, tamper-evident seals or sturdy wrapping materials.

    DRAP is committed to ensure the safety and quality of therapeutic goods in Pakistan, and protecting the public from substandard and falsified products.

    Registration Board Direction; Procedure for Capacity Assessment of the Contract Acceptor

    Asad Ullah Drugs, Regulatory Updates

    Registration Board in its 333rd meeting held on 19th – 20th December, 2023 discussed the subject mentioned case and decided as under: –

    1.         Inspection of contract accepter for manufacturing / testing capacity assessment shall be conducted for all those contract manufacturers, who has not been inspected for such purpose with in the last 3 years. The panel shall verify capacity assessment of all those sections, which are approved by the Licensing Division.

    2.         Capacity assessment of newly applied facility (Section) shall not be carried out, if any section of that manufacturing facility has already been assessed within last three years.

    3.         Following shall be prerequisites for submission of application for contract manufacturing under Rule 20(A) of Contract Manufacturing Policy.

    a.         Affidavit on stamp paper (Showing name, designation, CNIC Number of contract giver) stating installed capacity of the contract accepter for contract manufacturing. This affidavit shall only be signed by the CEO / MD of the firm. i.e. contract accepter.

    b.         Copy of DML of both firms. i.e. contract giver and contract accepter along with Section (s) approval from Licensing Division.

    c.         Valid GMP certificate or GMP inspection report of the contract accepter, conducted within last three years.

    d.         Copy of legalized contract between contract giver and contract accepter on stamp paper presenting the capacities of the contract accepter for the manufacturing sections for whom the products have been applied, and

    4.         Affidavits submitted by the contract accepter, showing manufacturing / testing capacity, will be verified in the subsequent inspections conducted for GMP / renewal of DML and will be reported accordingly. Chairman, Registration Board may constitute panel of experts to verify capacity assessment, if required.

    5.         The capacity verification report will be valid for 3 years.

    RB Direction Mar 24Download

    Recall Alert: Drug Product; INCIP 200mg Infusion (Batch # CPV-85) by Inventor Pharma Pvt Ltd, Karachi

    Asad Ullah Recall Alerts

    Recall Alert

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    DRAP Alert NoNo I/S/01-24-03
    Action Date16th January, 2024
    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. CPV-085 of product “INCIP Infusion” as of Substandard quality.

    Therapeutic Good(s) Affected: –

    Product NamesCompositionBatch No Manufacturer
    INCIP 200mg Infusion
     
    Reg.No 088363    		CiprofloxacinBatch No. CPV-85
     
    Mfg. Date: 09-23
    Exp. Date: 09-25    		M/s Inventor Pharma
    (Pvt) Ltd, Karachi
    Risk Statement:The impact of the use of substandard infusion on the basis of visible particulate matter may introduce contaminants into the bloodstream that lead to adverse reactions or sepsis.
    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.

      Rapid Alert: Contaminated Propylene Glycol (Batch #C815N3OR41) Allegedly Produced by Dow Chemical Thailand

      Asad Ullah Recall Alerts
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      Rapid Alert

      DRAP Alert NoNo  I/S/01-24-02
      Action Date11th January, 2024
      Target Audience1. Regulatory Field Force.
      2. Therapeutic Goods industry
      3. Manufactures of Oral liquid preparations
      4. Healthcare professionals
      Problem StatementThe regulatory field force has identified a batch of Propylene Glycol (PG) that was used as a solvent in the manufacturing of oral liquid preparations. The batch was labelled as manufactured by Dow Chemical, Thailand. However, on analysis of a sample by the Central Drug Laboratory in Karachi, an unacceptable level of Ethylene Glycol was found..

      The product identification details are as under: –

      Therapeutic Good Affected:-

      ProductBatch No*Mfg DateExp. DateManufacturer
      (as per label)      		Remarks
      Propylene Glycol
      (Raw Material)      		C815N3OR4103-2303-25Dow Chemicals, ThailandThe sample is declared substandard
      for unacceptable levels of Ethylene Glycol (EG).

      *Correction statement/corrigendum:
      Verification of record/pictures shows that the identified batch number of contaminated propylene glycol was inadvertently written as C815N30R41 instead of C815N3OR41. Hence this batch number may be read as C815N3OR41.
      Sincere apologies for the inconvenience this unanticipated ambiguity might have caused.

      Dow Chemicals Thailand provided clarification to DRAP, stating that the identified samples were not their original product. Furthermore, the investigation revealed that their labels were false and that the samples were not manufactured by Dow Chemicals.

      Risk StatementEthylene Glycol (EG) contaminated Propylene Glycol (PG) when used in oral liquid preparations, can lead to serious health risks due to EG’s toxicity. When ingested, EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal.
      Action InitiatedThe Regulatory Field Force has taken possession of a contaminated batch of Propylene Glycol and is investigating the entire supply chain of this batch. The therapeutic goods manufacturer has been instructed to recall any finished products that were manufactured using the same lot of propylene glycol. The Regulatory Field Force has also been instructed to seize all oral preparations that were made using the same batch of propylene glycol if found in the market. DRAP has directed the therapeutic industry to hold finished products manufactured from any other lot of propylene glycol of Dow Chemical Thailand and ensure testing of finished products for EG/DEG contamination before releasing them into the supply chain.
      Advice for Therapeutic Goods ManufacturersManufacturers of therapeutic goods are required to follow these instructions:
       
      _Recall Products: If any batch was manufactured using the same lot (C815N3OR41) of propylene glycol that has been identified as contaminated, all finished products from local and export markets should be recalled.

      –Hold Other Batches: All finished products manufactured from any other lot of propylene glycol of Dow Chemical Thailand should be held. These products should be tested for EG/DEG contamination before releasing them into the supply chain.

      –Screen Raw Materials: Before using them in the manufacturing of oral liquid preparations, all raw materials should be screened for contamination with EG and DEG.

      – Analyze Finished Products: Before their release into the market, all finished products should be analyzed for EG/DEG contamination.

      –Compliance: Ensure compliance with all directives issued by DRAP to safeguard public health from contaminated products.

      –Follow Guidelines: Adhere to the pharmacopoeia monograph and WHO guidelines for testing EG/DEG in oral liquid preparations during the analysis of both raw materials and finished products.

      Our utmost priority is public safety. DRAP is committed to supporting the industry in maintaining rigorous quality control and testing procedures to prevent any potential harm caused by contaminated products.
      Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to stay updated with advisories and recalls. Patients should be educated about the risks and symptoms of EG toxicity. Close monitoring of patients using the affected products is crucial, and any adverse events should be reported to National or Provincial pharmacovigilance centres.

      -Adverse Drug Reactions (ADR) or quality problems experienced with the use of these products 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 stay informed about the latest advisories and recalls from DRAP. If they have experienced any problem or unusual symptoms after using oral liquid preparations, seek medical attention immediately and 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.

      Press Release: Toxic Impurities Found In Raw Material; DRAP Directs Oral Liquid Manufacturers To Ensure Testing Of Raw Material For Imurties

      Asad Ullah Press Releases

      Islamabad, January 11, 2024 — The Drug Regulatory Authority of Pakistan (DRAP) has issued a warning to the therapeutic goods industry about a batch of propylene glycol raw material that has been found to be contaminated with ethylene glycol, a toxic substance that can cause serious health problems and even death.

      The report of Federal Government Analyst at Central Drug Laboratory, Karachi has revealed ethylene glycol contamination in the said batch of propylene glycol, in an amount much higher than the acceptable limit. The contaminated batch (C815N3OR41) was claimed to be manufactured by Dow Chemicals, Thailand. Initial investigations suggest that the integrity of the supply chain of the raw material may have been compromised.

      Propylene glycol, sorbitol and glycerin are used as solvents in the manufacturing of oral liquid preparations in the pharmaceutical and alternative medicines industry. In the past two years, there have been international reports related to the adulteration of these raw materials with Diethylene glycol (DEG) and Ethylene glycol (EG) causing kidney damage and death of children in Gambia, Uzbekistan, and Indonesia. Industrial-grade DEG and EG are used for various applications (solvents, antifreeze agent) in other industries.  

      DRAP has directed the pharmaceutical companies to immediately recall finished products from local and export markets that were manufactured using the mentioned batch of propylene glycol. The Regulatory Field Force has been instructed to confiscate the contaminated batch of propylene glycol, seize all oral preparations that were manufactured using the same batch of propylene glycol and submit the report within 24 hours. DRAP has also directed the therapeutic goods industry to hold finished products manufactured from any other lot of propylene glycol claimed to be manufactured by Dow Chemicals, Thailand and ensure testing of finished products for EG/DEG contamination before releasing them into the supply chain.

      The Central Drug Laboratory in Karachi is currently conducting analysis of both raw materials and finished products against the pharmacopoeial monograph and WHO guidelines for testing of EG/DEG in oral liquid preparations, respectively, as a part of the ongoing investigation.

      In December 2023, DRAP issued its third advisory to the pharmaceutical industry, requiring companies to screen raw materials for contamination with EG and DEG before using them in the manufacturing of oral liquid preparations. Additionally, all finished products must be analyzed for EG/DEG contamination before their release into the market. DRAP also issued directives to nutraceutical and alternative medicine companies to ensure compliance and safeguard public health from contaminated products.

      DRAP is committed to ensure the safety and quality of therapeutic goods in Pakistan, and protecting the public from substandard and falsified products.

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