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RECALL ALERT – DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY, KARACHI.

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DRAP Alert NoNo II/S/08-25-55
Action Date18 August, 2025.
Target Audience– National Regulatory Field Force.
– Pharmacists and Chemists in Distribution, Pharmacies and Medical Stores
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue Central Drugs Laboratory Karachi informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#Product NameBatch No.ManufacturersRemarks
1.Famila 28F Tablets
Each Tablet contains: Levonorgestrel…0.15mg
Ethinyl Estradiol…0.03mg
Ferrous Iron….24.37mg (Reg. No. 023941)		K185M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd.
A-46 SITE North Karachi (DML#000490)		‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol) and Assay(Levonorgestrel).
2.Famila 28F Tablets
Each Tablet contains: Levonorgestrel…..0.15mg
Ethinyl Estradiol…0.03mg
Ferrous Iron….24.37mg (Reg. No. 023941)		K189M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd.
A-46 SITE North Karachi (DML#000490)		‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol) and Assay (Levonorgestrel).
3.Famila 28F Tablets
Each Tablet contains: Levonorgestrel……0.15mg
Ethinyl Estradiol…0.03mg
Ferrous Iron….24.37mg (Reg. No. 023941)		K187M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd.
A-46 SITE North Karachi (DML#000490)  		‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol), Weight variation of Ferrous Iron and Assay (Levonorgestrel & Ethinyl Estradiol).  
4.Famila 28F Tablets
Each Tablet contains: Levonorgestrel……0.15mg
Ethinyl Estradiol…0.03mg
Ferrous Iron….24.37mg (Reg. No. 023941)		K192M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd.
A-46 SITE North Karachi (DML#000490)  		‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol), and Assay (Levonorgestrel & Ethinyl Estradiol).  
5.Famila 28F Tablets
Each Tablet contains: Levonorgestrel……0.15mg
Ethinyl Estradiol…0.03mg
Ferrous Iron….24.37mg (Reg. No. 023941)		K194M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd.
A-46 SITE North Karachi (DML#000490)  		‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol), and Assay (Levonorgestrel).  
6.Famila 28F Tablets
Each Tablet contains: Levonorgestrel……0.15mg
Ethinyl Estradiol…0.03mg
Ferrous Iron….24.37mg (Reg. No. 023941)		K195M/s. ZAFA Pharmaceutical Laboratories (Pvt.) Ltd.
A-46 SITE North Karachi (DML#000490)  		‘Substandard’ on the basis of tests of content uniformity (Levonorgestrel, Ethinyl Estradiol), and Assay (Levonorgestrel).  
    7.Imcomox 125mg/5ml Suspension Each 5ml of reconstituted suspension contains: Amoxicillin (as Trihydrate) ………………….125mg (Reg. No. 013756)029M/s. Imco Pharmaceutical Lab.
73/A Industrial Estate Jamrud Road, Peshawar
(DML#000317)		‘Substandard’ on the basis of Assay (Amoxicillin trihydrate).  
8.Imcodal Oral Suspension
Each 5ml of Suspension contains: Metronidazole Benzoate.. 64mg
Ethinyl Furazolidone….25mg
(Reg. No. 013363)		013M/s. Imco Pharmaceutical Lab.
73/A Industrial Estate Jamrud Road, Peshawar
(DML#000317)		‘Substandard’ on the basis of Assay (Furazolidone).
Risk Statement:Famila 28F: The affected batches of Famila 28F Tablets due to content uniformity, assay failures of hormonal ingredients, and weight variation in the iron component, may lead to reduced contraceptive efficacy, hormonal imbalance, and inconsistent iron supplementation, increasing the risk of complications, particularly in vulnerable groups such as Young Women, Perimenopausal Women, Women with history of Anemia, Patients with Comorbidities.

Imcomox: Laboratory testing has confirmed that the amoxicillin content in this drug product is below the approved specification range, making it subpotent. Such reduced strength may cause treatment failure, particularly in infants and young children, the primary users of this medicine. The recall is being undertaken to prevent potential health risks and safeguard public safety.

Imcodal: Laboratory testing has confirmed that the furazolidone content in this suspension is below the approved specification range, indicating subpotency. Inadequate active ingredient may lead to ineffective treatment of gastrointestinal infections, particularly in children, who are the primary recipients of this medicine. This recall is being carried out to prevent treatment failure and protect public health.
Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market.

– All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks 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 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 these 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 – CRACKDOWN AGAINST UNLICENSED/UNAUTHORIZED MANUFACTURERS

    Ahsan Hafiz Recall Alerts
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    Rapid Alert

    CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

    DRAP Alert NoNo I/S/08-25-54
    Action Date11th August, 2025
    Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
    2. Healthcare Professionals
    3. Pharmacies and medical stores
    Problem StatementThe Drug Regulatory Authority of Pakistan (DRAP) has received information from the Drug, Water and Food Testing Laboratory, Gilgit-Baltistan, indicating that the following purported drug products have been declared ‘spurious’ upon analysis and reportedly manufactured by entities not licensed or authorized by DRAP. The relevant laboratory findings and product details are as under:

    The product identification details are as under: –

    Therapeutic Good Affected:-

    S#Product NameBatch No.Purported ManufacturerRemarks
    1Missron Tablet   Each Tablet contains Dydrogesterone ……. 10mg  48022M/s Fegga Pharmaceutical, F-21/H.P.T.C., S.I.T.E., KARACHI.Drug Water and Food Testing Laboratory  Gilgit Baltistan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
    2Quttefol OD tablets   Each film coated tablet contains L-Methyl-Folate (Folic Acid) …………………… 800 mcg Vitamin B12 …….1000 mcgQL-001M/s Adcok Pharmaceuticals Factory 3-km Defense Road Off-Raiwind Road, LahoreDrug Water and Food Testing Laboratory Gilgit Baltistan declared the purported drug product as under: – For assay of Vitamin B12, ‘Spurious’ as defined under clause (i) of sub-section (z-b) of Section 3 of the Drugs Act, 1976 & For assay of Folic Acid,   ‘Substandard’  as defined under sub-section (zz) of Section 3 of the Drugs Act, 1976.
    3Depasrone Tablets   Each Tablet contains Dydrogesterone ……. 10mg  2406M/s Alpine Laboratories, Plot A-41, S.I.T.E., KarachiDrug Water and Food Testing Laboratory  Gilgit Baltistan declared the purported drug product as ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
    4Dropha Tablets   Each Tablet contains Dydrogesterone ……. 10mg  DRP-0004M/s Himax Pharmaceutical, Plot # 445, Korangi Industrial Area, KarachiDrug Water and Food Testing Laboratory  Gilgit Baltistan declared the purported drug product as  ‘Spurious’ as defined under clause (i) & (ii) of sub-section (z-b) of Section 3 of the Drugs Act, 1976.
    Risk StatementAll the above-mentioned purported drug products have been confirmed as falsified/spurious, as they are manufactured by entities that are neither licensed nor authorized by the Drug Regulatory Authority of Pakistan (DRAP). These products are being illegally manufactured and marketed without regulatory oversight, rendering their quality, safety, and efficacy highly doubtful. Laboratory testing has revealed the absence of active pharmaceutical ingredients in some samples, indicating a complete lack of therapeutic value. The circulation and use of such unregulated products pose a serious risk to public health, including treatment failure, disease progression, and potential life-threatening consequences. The public is strongly advised to avoid the use of these unregistered drug products and report any suspicious or unauthorized medicines to DRAP through its official reporting channels.
    Action InitiatedThe Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product.

    All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
    Advice for Healthcare ProfessionalsDRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link.
    Advice for ConsumersConsumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products 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.

    Recent Policy Updates and Procedural Guidelines for Drug Registration and Processing

    Yasir Mahmood Drugs
    1. Streamlining The Evaluation and Processing of Form 5F (Common Technical Document) Applications Under S.R.O. 713(I)/ 2018.
    2. Submission of Summary of Product Characteristics (SmPC) And Patient Information Leaflet (PIL) Along with CTD Dossier (Form 5-F).​
    3. Borrowing of APIS for Performing Product Development, R & D and Stability Testing Registration Board Decision Thereof.
    4. Quality-Based Incentivisation of Applications for Local Manufacturers​
    5. Revised Policy for Registration and Enlistment of Formulations Containing Vitamins and Minerals

    Streamlining The Evaluation and Processing of Form 5F (Common Technical Document) Applications Under S.R.O. 713(I)/ 2018.

    Streamlining-The-Evaluation-and-Processing-of-Form-5F-Common-Technical-Document-Applications-Under-S.R.O.-713I2018Download

    Submission of Summary of Product Characteristics (SmPC) And Patient Information Leaflet (PIL) Along with CTD Dossier (Form 5-F).​

    Submission-of-Summary-of-Product-Characteristics-SmPC-And-Patient-Information-Leaflet-PIL-Along-with-CTD-Dossier-Form-5-F._Download

    Borrowing of APIS for Performing Product Development, R & D and Stability Testing Registration Board Decision Thereof.

    Borrowing-of-APIS-for-Performing-Product-Development-R-D-and-Stability-Testing-Registration-Board-Decision-Thereof.Download

    Quality-Based Incentivisation of Applications for Local Manufacturers​

    Quality-Based-Incentivisation-of-Applications-for-Local-Manufacturers_Download

    Revised Policy for Registration and Enlistment of Formulations Containing Vitamins and Minerals

    Revised-Policy-for-Registration-and-Enlistment-of-Formulations-Containing-Vitamins-and-MineralsDownload

    VOLUNTARY RECALL ALERT – Amoxil Forte Suspension & Amoxil Suspension due to complaint of Induction Seal.

    Ahsan Hafiz Recall Alerts

    Recall Alert

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    DRAP Alert NoNo II/V/08-25-53
    Action Date05th August 2025.
    Target Audience– National Regulatory Field Force.
    – Pharmacists and Chemists     in Distribution, Pharmacies and Medical Stores
    – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
    – General Public
    Problem / Issue M/s GlaxoSmithKline Pakistan Ltd., F-268, S.I.T.E., Karachi (DML No. 000233) has informed the Drug Regulatory Authority of Pakistan (DRAP) that the following drug products are being voluntarily recalled due to defective induction seal.

    Therapeutic Goods (s) Affected: –

    S#Product NameManufacturersBatch No.
    1Amoxil Forte Suspension 250 mg
    (Reg. # 006814)    		M/s GlaxoSmithKline Pakistan Ltd. F-268 SITE Karachi
    (DML # 000233)    		7W9V, 7W9W, 7W9X, 8L5H, 8R3M, 8L5J, 8R4J, 8R4G, 8R3N, 8R4M, 8R4N, 8T5A, 9S5D, 9S5B, 9U6F, 9X3E, 9U6E, 9X3G, 9X3F, AH9Y, AJ2A, AP2M, AP2N, AP2P, AP2T, AS5B, AS5K, AS5F, AT7M, AS5L, C25W, C25X, C37E, C37G, C99F, C58B, CB4N, CB4P, CB4R, CD6T, CD6W, CD6V, DL5L, DL5K, DL5M, EE9R, EE9N, DY5U, EE9T, EG2A, FA8M, FA8N, FB9C, FB9D, FB9E, FB9F, FE9X, FF2A  
     2Amoxil Suspension 125 mg
    (Reg. # 000508)    		M/s GlaxoSmithKline Pakistan Ltd. F-268 SITE Karachi
    (DML # 000233)    		8U3B, 8T5G, 8T5L, 8U3A, 8U3G, 8U3H, 8W9S, 8W9T, 925W, 925Y, 926B, 926A, 956M, 956R, 966V, 967C, 967F, 967E, 988F, 988H, 988G, 9B4P, 988K, 9B4M, 9B4S, 9D6K, 9B4T, 9D6M, 9D6P, 9D6T, 9G4N, 9G4P, 9L9N, 9L9M, 9P7R, 9P7S, 9R2V, 9R2U, 9S4Y, 9S5A, AW3A, AW3B, AW3H, AW3D, AY5T, AY5X, AY5V, AY6B, B44T, B44M, B44S, BB2Y, B44V, BB3A, BB3B, BF3B, BF2X, BB3C, BF3C, BF3A, BT9H, BT9G, BT9F, BT9J, BW8R, BW8M, BW8S, BW8T, BX8L, BX8N, BX8P, CG4V, CG4X, CG4W, CG4Y, CJ7B, CJ6W, CJ7C, CJ7D, CP5G, CP5H, CT5X, CT6A, CW3H, CW3G, CY3A, D64P, D64S, CY3K, EP7E, EN4U, EN4T, EP7J, EP7M, EP7P, ET8M, EW3F, F55S, F32W, F55V, F55U, F55T, F97P, F75G, F75J, F75K, F75N, FT2Y, FU7X, FU7Y, FT3A
    Risk Statement:These drug products are being voluntarily recalled by the manufacturer due to a quality defect related to the defective induction seal of bottles, which may potentially compromise product integrity. The undetected defect may pose risk under certain conditions of storage or use. This recall is being carried out as a precautionary measure in consultation with the Drug Regulatory Authority of Pakistan (DRAP) to safeguard public health.
    Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market.
    – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

    –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 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 these 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 – BATCHES OF ‘TABLET FAMILA 28F’ DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

      Ahsan Hafiz Recall Alerts

      Recall Alert

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      DRAP Alert NoNo II/S/08-25-52
      Action Date04 August, 2025.
      Target Audience– National Regulatory Field Force.
      – Pharmacists and Chemists       in Distribution, Pharmacies and Medical Stores
      – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
      – General Public
      Problem / Issue Central Drugs Laboratory Karachi informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug product has been declared as ‘Substandard’.

      Therapeutic Goods (s) Affected: –

      Product Details: Famila 28F Tablets (Reg. # 023941)

      Manufactured by: M/s Zafa Pharmaceuticals Lab (Pvt) Ltd.  (DML # 000490)

      Batch No.CDL Test Result / Remarks
      K217‘Substandard’ on the basis of tests (Content uniformity of Levonorgestrel & Ethinyl Estradiol. Weight variation of Ferrous Iron).
      K177‘Substandard’ on the basis of tests (Content uniformity of Levonorgestrel & Ethinyl Estradiol. Weight variation of Ferrous Iron. Assay test of Levonorgestrel.)
      K203, K207‘Substandard’ on the basis of test of weight variation of Ferrous Iron.
      K184, K190, K191‘Substandard’ on the basis of tests of Content uniformity of Levonorgestrel & Ethinyl Estradiol. Assay test of Levonorgestrel.
      K182‘Substandard’ on the basis of tests of Content uniformity of Levonorgestrel & Ethinyl Estradiol. Weight variation of Ferrous Iron.
      K199, K205‘Substandard’ on the basis of tests Content uniformity of Ethinyl Estradiol & Weight variation of Ferrous Iron.
      K204‘Substandard’ on the basis of test of Content uniformity of Levonorgestrel & Ethinyl Estradiol.
      Risk Statement:The affected batches of Famila 28F Tablets due to content uniformity, assay failures of hormonal ingredients, and weight variation in the iron component, may lead to reduced contraceptive efficacy, hormonal imbalance, and inconsistent iron supplementation.
      Use of such products can cause therapy failure and complications.
      Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market.

      – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks 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 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 these 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 – MEDICAL DEVICES DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

        Ahsan Hafiz Recall Alerts

        Recall Alert

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        DRAP Alert NoNo I/S/07-25-51
        Action Date29 July, 2025.
        Target Audience– National Regulatory Field Force.
        – Pharmacists and Chemists         in Distribution, Pharmacies and Medical Stores
        – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
        – General Public
        Problem / Issue Central Drugs Laboratory Karachi informed Drug Regulatory Authority of Pakistan that the samples of below mentioned Medical Devices have been reported as ‘Substandard’.

        Therapeutic Goods (s) Affected: –

        Product NamesBatch DetailsManufactured byTest Results
        ZINDAGI Auto Disable Syringe 5ml
        (MDMR-000117)        		5-01E-25M/s Al-Badar Manufacturing (Pvt.) Ltd. Gadoon Amazai KPK (ELM-0029)‘Substandard’ on the basis of Sterility Test.
        Ultra Fine SMD Painless Syringe 5ml
        (MDMR-000229)        		5053CEM/s Sehat Medical Device (Pvt.) Ltd, Lahore. (ELM-0065) ‘Substandard’ on the basis of Sterility Test & description test (The clear visible black particles found in the barrel of syringe).
        Ultra Fine SMD Painless Syringe 3ml
        (MDMR-000229)        		3022CDM/s Sehat Medical Device (Pvt.) Ltd, Lahore. (ELM-0065) ‘Substandard’ on the basis of Sterility Test & description test (The clear visible black particles found in the barrel of syringe).
        Risk Statement:Use of substandard syringes, in invasive or intravenous procedures, poses a significant risk of introducing microbial contaminants into the patient’s body, which may result in localized infections, abscesses, or life-threatening systemic infections, particularly in immunocompromised individuals.
        Action Initiated– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market.
        – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product.

        –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 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 these 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.