Home > 2025

Year: 2025

RAPID ALERT: UNREGISTERED & SUBSTANDARD — LEVITRA 20 mg TABLET (Batch BXNZ2488)

Ahsan Hafiz Recall Alerts
Download

Rapid Alert

CRACKDOWN AGAINST UNREGISTERED / FALSIFIED DRUG PRODUCTS

DRAP Alert NoNo I/S/10-25-83
Action Date08th October, 2025
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementCentral Drugs Laboratory Karachi declared the following drug product as unregistered / falsified.

The product identification details are as under: –

Therapeutic Good Affected:-

S#Product NameBatch No.Purported ManufacturerRemarks
1.Tablet Levitra 20mg   Each film coated tablet contains: Vardenafil (as HCl trihydrate) ……… 20mg  BXNZ2488Purported to be manufactured by   M/s Bayer Pharma AG GermanyThe sample has been declared ‘Unregistered / falsified’ .
Risk StatementSince the product is not registered with DRAP, its quality, safety, and efficacy have not been evaluated or approved. The batch may contain incorrect or variable amounts of the active ingredient, unknown impurities, or be manufactured under non-compliant manufacturing conditions. Patients using this product may experience therapeutic failure, unpredictable adverse reactions, or serious health consequences due to lack of assured quality and authenticity. Misrepresentation of association with a well-known multinational company further increases the risk of false confidence, delayed appropriate treatment, and medication errors.
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.

Recall Alert – Orange Auto disable Syringes 5mL (Batch # S5102402), DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

Ahsan Hafiz Recall Alerts

Recall Alert

Download

MEDICAL DEVICE DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

DRAP Alert NoNo I/S/09-25-82
Action Date30 September, 2025.
Target Audience– National Regulatory Field Force of DRAP and Provincial Drug Control Departments.
– Healthcare Professionals – Physicians, Pharmacists, and Nurses.
– General Public
Problem / Issue Central Drugs Laboratory (CDL) Karachi, has declared the sample of below mentioned Medical Device as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#Product NameBatch No.ManufacturersRemarks
1.Orange Auto disable Syringes 5ml
(MDMR # 000078)		S5102402M/s Silver Surgical Complex (Pvt) Ltd,
C-40, S.I.T.E II, Super Highway Industrial Area Scheem 33, Karachi.
(ELM # 0007)		Sample has been declared of ‘substandard’ quality on the basis of results for Auto disable feature.
Risk Statement:This defect poses a high risk of reuse of syringes, which may result in cross-contamination and transmission of bloodborne infections such as HIV, hepatitis B, and hepatitis C. Because the defect is not visually detectable before use, healthcare professionals and patients remain unaware of the risk. Given the widespread use of such syringes in general healthcare settings, including immunization programs and vulnerable populations, the risk is categorized as HIGH, and immediate market withdrawal and user alert are necessary to protect public health.
Action Initiated– The field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches 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 – FALSIFIED / SPURIOUS DRUG PRODUCT IN THE MARKET.

    Ahsan Hafiz Recall Alerts
    Download

    Rapid Alert

    CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS

    DRAP Alert NoNo I/S/09-25-81
    Action Date26th September, 2025
    Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
    2. Healthcare Professionals
    3. Pharmacies and medical stores
    Problem StatementDirectorate of Drugs Control Punjab (DDCP) have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared ‘Spurious’ as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. The details of reports are as under:

    The product identification details are as under: –

    Therapeutic Good Affected:-

    S#Product NameBatch No.Purported ManufacturerRemarks
    1.Саpsule Eskem 40 MG  

    Each Capsule Contains:

    Enetric Coated Pellets of Esomeprazole Magnesium Tri-hydrate Equivalent to Esomeprazole ……. 40 Mg

      (Reg.# 044310)      		Not mentionedPurported to be manufactured by  
    M/s High-Q Pharmaceuticals,
    Plot No. 224 & 225/1, Sector 23, Korangi Industrial Area, Karachi.    		‘Substandard’ with respect to physical characteristics and “Misbranded” as defined under clause (i) of sub-section (s) of section 3 of The Drugs Act, 1976 and “Spurious” as defined under clause (i) & iii of subsection (zb) of section 3 of The Drugs Act, 1976.

    Details: Product label on outer carton does not bear batch number and immediate blister have illegible embossed marking. Moreover, as per the manufacturer’s method, the product is described as amethyst-colored capsules with the cap imprinted ‘High Q’ in black and the body imprinted Eskem 40, However, no such printing was observed on the actual capsules. Esomeprazole is not identified. Omeprazole is identified.
    Risk StatementCritical non-compliances include absence of batch number on the outer carton, illegible embossed markings on immediate blister packs, and deviation from the manufacturer’s approved description of capsule appearance (color and printing). Analytical testing confirmed that Esomeprazole was not identified and instead Omeprazole was detected, representing potential therapeutic failure and risk of inappropriate treatment. The presence of a spurious and misbranded product in the supply chain poses a serious threat to patient safety due to lack of assured identity, quality, and efficacy and requires immediate regulatory and field action to prevent its distribution and use.
    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.

    RECALL ALERT -TABLET AMLOshine (all strengths & batches) – Sunshine Pharmaceuticals

    Ahsan Hafiz Recall Alerts

    Recall Alert

    Download

    Immediate Withdrawal of all batches of AMLOshine Tablet 5mg (Reg # 062420) & Tablet AMLOshine 10 mg (Reg. # 062419)

    manufactured by M/s Sunshine Pharmaceuticals

    DRAP Alert NoNo II/S/09-25-80
    Action Date26 September, 2025.
    Target Audience– National Regulatory Field Force.
    – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
    – General Public
    Problem / Issue In continuation to DRAP Alert No. NoII/S/05-25-45 dated 2nd June 2025, wherein three batches (7840, 7623, 7361) of Tablet AMLOshine 5mg [contains Amlodipine (as Beysalte) 5mg] bearing Reg. # 62420, and manufactured by M/s Sunshine Pharmaceuticals. Emanabad, G.T. Road, Gujranwala (DML # 000662) declared ‘substandard’ by Provincial Drug Testing Laboratory on the basis of impurities testing.
    The panel of inspectors of DRAP accordingly conducted inspection at manufacturing unit of M/s. Sunshine Pharmaceuticals, Khan Payara, Near Saim Nala, Emanabad, Gujranwala, revealed multiple critical non-compliances with Good Manufacturing Practices (GMP). These included the absence of vendor qualification, failure to perform impurities testing and analytical method validation, unjustified use of API overages, lack of process validation, failure to investigate assay deviations observed in stability data, and the non-availability of impurity reference standards. The panel advised firm to initiate an immediate recall of all batches of AMLOshine Tablet 5mg (Reg # 062420) & Tablet AMLOshine 10 mg (Reg. # 062419).
    Registration of Tablet AMLOshine 5 mg (Reg. #062420) and Tablet AMLOshine 10 mg (Reg. # 062419) are under suspension proceedings.
    Risk Statement:The presence of impurities, lack of validated testing, and failure to investigate assay deviations in AMLOshine Tablets may compromise product quality, leading to reduced therapeutic efficacy and potential treatment failure in patients requiring amlodipine for hypertension and cardiovascular conditions. Such deficiencies may also expose patients to unpredictable adverse effects, particularly among the elderly, long-term users, and those with comorbidities. In view of the nature of defect and potential health risks, the issue is classified as a Class II Recall, as the defect may cause illness or treatment failure but is not considered immediately life-threatening.
    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 – DRUG PRODUCTS (CLASS – I).

      Ahsan Hafiz Recall Alerts

      Recall Alert

      Download

      DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

      DRAP Alert NoNo I/S/09-25-79
      Action Date25 September, 2025.
      Target Audience– National Regulatory Field Force.
      – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
      – General Public
      Problem / Issue Directorate of Drugs Control Punjab (DDCP) 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.Injection. Lignozin-A 2mL Each ml ampoule contains: Lignocaine HCI B.P…….. 20mg Adrenaline B.P………….1:80,000LG-001M/s Trigon Pharmaceuticals (Pvt) Ltd. 8- Km Thokar Raiwind Road Lahore. (DML # 000342)“Misbranded” as per Section 3(s)(iv) of The Drugs Act 1976 and “Sub-Standard” on the basis of Physical Test i.e Physical Description Test (Visible Particles), pH Test & Assay of Adrenaline.
      2.Satamin Injection Each ampoule contains: (Mecobalamin J.P) 500ugMC24-030M/s Saturn Pharmaceuticals (Pvt) Ltd. 23-Km, Thokar Raiwind Road Lahore. (DML # 000734).‘Adulterated’ as per Section_3 (a) (v) of The Drugs Act 1976.
      Risk Statement:The defects identified in the sampled injections pose serious risks to patient safety and therapeutic effectiveness. Injection Lignozin-A 2 mL (Batch LG-001) manufactured by M/s Trigon Pharmaceuticals (Pvt.) Ltd. has been declared Misbranded under Section 3(s)(iv) of the Drugs Act, 1976, and Substandard on the basis of physical description (visible particles), pH, and assay of adrenaline, raising concerns of compromised sterility, safety, and efficacy. Similarly, Satamin Injection (Batch MC24-030) manufactured by M/s Saturn Pharmaceuticals (Pvt.) Ltd. has been declared Adulterated under Section 3(a)(v) of the Drugs Act, 1976, which represents a severe violation of product quality and purity standards. The circulation and use of these defective products may lead to therapeutic failure, unpredictable adverse reactions, and potential harm to patients, warranting urgent regulatory and recall action.
      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 – TABLET ASCARD-75 (Batch # AR046L)

        Ahsan Hafiz Recall Alerts

        Recall Alert

        Download

        DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

        DRAP Alert NoNo II/S/09-25-78
        Action Date23 September, 2025.
        Target Audience– National Regulatory Field Force.
        – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
        – General Public
        Problem / Issue Directorate of Drugs Control Punjab (DDCP) 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.Tablet Ascard-75   Each enteric coated tablet contains: Acetylsalicylic Acid (Aspirin BP)……………75 mgAR046LM/s Atco Laboratories Limited, B-18 S.I.T.E Karachi. (DML # 000188)‘Sub-Standard’ with regards to Related Substances Test (Impurity C: Salicylic Acid).
        Risk Statement:The Drug Testing Laboratory has declared the given sample as ‘substandard’ on basis of failure in the Related Substances Test, showing the presence of Impurity C (Salicylic Acid) beyond the permissible pharmacopeial limits. The presence of such impurity may lead to adverse effects including gastric irritation and related complications, particularly in sensitive patient populations. While not considered immediately life-threatening, this defect poses a significant quality concern that may cause temporary or medically reversible adverse health consequences.
        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 – Class II (Tablet Ascard-75) Batch # AR021L

          Ahsan Hafiz Recall Alerts

          Recall Alert

          Download

          PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

          DRAP Alert NoNo II/S/09-25-77
          Action Date23 September, 2025.
          Target Audience– National Regulatory Field Force.
          – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
          – General Public
          Problem / Issue Directorate of Drugs Control Punjab (DDCP) 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.Tablet Ascard-75   Each enteric coated tablet contains: Acetylsalicylic Acid (Aspirin BP)……………75 mgAR021LM/s Atco Laboratories Limited, B-18 S.I.T.E Karachi. (DML # 000188)‘Sub-Standard’ with regards to Related Substances Test (Impurity C: Salicylic Acid).
          Risk Statement:The Drug Testing Laboratory has declared the given sample as ‘substandard’ on basis of failure in the Related Substances Test, showing the presence of Impurity C (Salicylic Acid) beyond the permissible pharmacopeial limits. The presence of such impurity may lead to adverse effects including gastric irritation and related complications, particularly in sensitive patient populations. While not considered immediately life-threatening, this defect poses a significant quality concern that may cause temporary or medically reversible adverse health consequences.
          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.