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36. Recall Alert – Medical Devices Declared Substandard by CDL Karachi

Salateen Philip Recall Alerts

Recall Alert

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MEDICAL DEVICES DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI  
DRAP Alert NoNo I/S/07-26-36
Action Date14 July, 2026
Target Audience– National Regulatory Field Force.
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue Central Drugs Laboratory (CDL), Karachi has informed that samples of the below-mentioned Medical Devices have been declared “Substandard”.

Therapeutic Goods (s) Affected: –

S#Product NameBatch No.Manufacturer / Importer detailsRemarks
1BD 10ML Syringe (MDMR-0000035)5349764Manufacturer: Becton Dickinson Medical (S) Pte. Ltd.
30 Tuas Avenue 2, Singapore. Importer: M/s Asto Life Sciences (Pvt.) Ltd. Plaza #1, Block Orchard-1, Gate #2, Paragon City, Barki Road, Lahore. (ELI-00103)		Substandard  on the basis of Absorbance test.
2.Accuject Auto-Disable Syringe 5ml (MDMR-000507)S502E26Manufacturer: M/s Faiz Surgical and Medical Industries (Pvt.) Ltd. Plot No. 540-B, Sundar Industrial Estate, Lahore. (ELM-0093)  Substandard  on the basis of Sterility test.
Risk Statement:The affected batches have been declared substandard due to failure of critical quality tests. The BD 10 mL Syringe (Batch No. 5349764) failed the Absorbance test, indicating excessive extractable substances that may compromise product safety and quality for parenteral use. The Accuject Auto-Disable Syringe 5 mL (Batch No. S502E26) failed the Sterility test, indicating possible microbial contamination that may increase the risk of infection, including serious systemic infections, upon use.
Action Initiated-The field force of DRAP and Provincial Drug Control Departments has been directed to immediately conduct market surveys for detection of presence and removal of the affected batches from the market. Manufacturers, importers and distributors have been directed to initiate recall of the affected batches in accordance with applicable regulatory requirements.
–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 increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above mentioned batches of the drug product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse
Event Reporting Form or online through this link.  Further information of reporting problems to DRAP is available on this link.
Advice for Pharmacies/Medical stores: –All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the above-mentioned batches. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units should also increase surveillance in the market to ensure effective recall of the affected products.
Advice for ConsumersConsumers and healthcare facilities in possession of the affected batches should immediately stop using these products and contact the supplier, distributor or manufacturer for return or replacement. Any adverse event or quality issue associated with the use of these products should be reported to DRAP/National Pharmacovigilance Centre.

    National Pharmacovigilance Cell (NPC), DRAP released a revised draft of Guidelines on National Pharmacovigilance System (Edition 05) seeking comments from stakeholders.

    Abdul Qadir Pharmacovigilance

    The Drug Regulatory Authority of Pakistan (DRAP) has established the National Pharmacovigilance Centre (NPC) under the Division of Pharmacy Services to oversee the safety monitoring of therapeutic goods across the country. The NPC works in close collaboration with national and international stakeholders to strengthen and sustain an effective pharmacovigilance system in Pakistan. Since 2018, Pakistan has been a full member of the World Health Organization Programme for International Drug Monitoring (WHO Programme for International Drug Monitoring), coordinated by the Uppsala Monitoring Centre (UMC), Sweden. At present, Pharmacovigilance Centres have been notified in all provinces, as well as within public health programmes, which contribute adverse event reports to the National Pharmacovigilance Database.

    To facilitate timely reporting and effective safety surveillance, the NPC has developed a comprehensive, multi-channel reporting system for registration holders, hospitals, public health programmes, healthcare professionals, and the public. The Pharmacovigilance Rules, 2022 establish the legal framework governing pharmacovigilance activities in Pakistan and define the responsibilities of all stakeholders for maintaining pharmacovigilance systems and reporting safety data to the NPC.

    Overall, these guidelines provide practical guidance to public sector stakeholders on the implementation of pharmacovigilance activities, covering the entire safety monitoring process from the identification and reporting of adverse events to signal detection, risk assessment, regulatory decision-making, and implementation of appropriate risk minimization measures. The guidelines have been comprehensively revised to reflect the evolving roles and responsibilities of stakeholders under the collaborative safety monitoring programme, align with current international best practices, and promote a coordinated, efficient, and transparent pharmacovigilance system. The revised guidance aims to clarify stakeholder responsibilities, eliminate duplication of efforts, strengthen collaboration among participating institutions, and enhance the quality and quantity of safety reporting across Pakistan.

    The draft of revised guidelines is uploaded on the official website of DRAP on the 6th of July 2026 to seek comments and suggestions from stakeholders on the draft document. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using the prescribed format. For further guidelines on submitting comments, visit the DRAP website or click here. Comments and suggestions can be forwarded via email to pv∂dra.gov.pk or can be posted at the mailing address, Director, Division of Pharmacy Services, Drug Regulatory Authority of Pakistan, Prime Minister’s National Health Complex, Park Road, Islamabad.

    1-NPVG guidelines reviewed final 6-7-26Download

    35. Recall Alert – DTL Punjab Declared Substandard Drug Products.

    Salateen Philip Recall Alerts

    Recall Alert

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    DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL LABORATORIES
    DRAP Alert NoNo I/S/06-26-35
    Action Date18 June, 2026.
    Target Audience– National Regulatory Field Force.
    – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
    – General Public
    Problem / Issue Drug Testing Laboratories (DTL) Punjab informed that the samples of below mentioned drug products have been declared as ‘Substandard/Adulterated’.

    Therapeutic Goods (s) Affected: –

    S#Product NameBatchManufacturersRemarks
    1.Neocobal 0.5 mg Injection
    Each ml contains:
    Mecobalamin ……..0.5mg  
    (Reg. # 071447)    		S-3052M/s Pulse Pharmaceuticals (Pvt) Ltd.  
    Mozay Badoke Raiwind Road (Sua Asil Road) Lahore.
    (DML # 000564)    		The sample is declared as “sub-standard” on the basis of Assay Test & “adulterated” as per section 3 (a) (iv) of The Drugs Act 1976 (Cyanocobalamin is Identified).
    2.GAMMARAAS Injection
    Immune Globulin Injection (Human) 5%, 2.5g, 50ml/vial
    (Reg. # 031350)    		202311G042Imported & Distributed by Popular International (Pvt.) Ltd.
    141, Justice Inamullah Road, Block 7 & 8 KMCHS, Karachi.    		The sample is declared as “sub-standard” with regards to Description & Sterility test.
    3.Injection. KAMEDEX 1mL
    Each ml contains:
    Dexamethasone Sodium Phosphate eq. to Dexamethasone phosphate 4 mg (Reg. # 074983)    		DX-2642M/s Amaan Pharma. 
    30-Km Sheikhupura Road Lahore  
    (DML # 000808)    		The sample has been declared Adulterated as per Section 3 (a) (v) of The Drugs Act 1976 (label claims Dexamethasone Sodium Phosphate equivalent to Dexamethasone Phosphate 4 mg/mL, laboratory analysis identified Dexamethasone base at a much lower level, rendering the composition false and misleading).
    4.BRZOLE 500mg/100ml Infusion
    Each vial contains: Metronidazole….500mg/100ml
    (Reg. # 099612)    		25055M/s Berlex Lab. International,
    10-Km Nangshah Chowk Karachi Road Multan
    (DML # 000678)    		The sample is declared as “sub-standard” with regards to Bacterial Endotoxin test.
    5.Metrorise Infusion Metronidazole….500mg/100ml
    (Reg. # 040412-D)    		LV-2514M/s Pak Risen Pharmaceuticals.
    Plot No. 3 Block B Phase-I-II Industrial Estate Hattar.
    (DML # 000573)      		The sample has been declared “Substandard” on the basis of Bacterial Endotoxin Test & Visible particles.
    6.Murcobal Injection 500 mcg
    Each ml Contains Mecobalamin…500mcg
    (Reg. # 045904)    		109M/s Murfy Pharmaceuticals (Pvt) Ltd. 
    8-Km Raiwind Road Lahore.
    (DML # 000543)    		The sample is declared as “sub-standard” on the basis of Assay Test & “adulterated” as per section 3 (a) (iv) of The Drugs Act 1976 (Cyanocobalamin is Identified).
    7.Premvil Infusion 1gm/100 ml
    Each l00ml contains: Paracetamol………….1gm  
    (Reg. # 125218)    		PNO-2510Ahad International Pharmaceutical LTD
    13-Km, Multan Road, Dera Ismail Khan    		The sample is declared as “sub-standard” with regards to Visible Particulates
    8.Aqua-P Injection  Sterile water for injection 5mlP-673M/s Ipram International.  Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551)Sub-standard’ on the basis of Bacterial Endotoxin Test.
    9.ZYOCAIN Gel
    Lignocaine Hydrochloride B.P 2% w/v
    (Reg # 012523)    		008  M/s PharmaWise Labs (Pvt) Ltd.  25-M Industrial Area Kot Lakhpat Lahore. (DML # 000182)Sub-standard’ on the basis of Sterility test
    10.Injection Cara-Lac 30mg/1ml
    Each 1ml contains: –
    Ketorolac Tromethamine equivalent to Ketorolac………30mg
    (Reg. # 054997)    		25G022M/s Caraway Pharmaceuticals.
    Plot No. 12 Street No. N-3 National Industrial Zone (RCCI) Rawat.
    (DML # 000629)    		The sample is declared as “sub-standard” on the basis of Test for Impurities i.e. Organic Impurities.
    11.Sterile Water for Injection 5ml  20334M/s NovaMed Pharmaceuticals (Pvt) Ltd.
    28-Km Ferozepur Road Lahore
    (DML # 000590)    		Sub-standard’ on the basis of Bacterial Endotoxin Test.
    Risk Statement:The affected products have been found to possess critical quality defects, including failure of sterility, bacterial endotoxin, assay, impurity, and visible particulate tests, while certain products were also declared adulterated due to misidentified active ingredients or misleading composition. Use of these products may result in treatment failure, serious infections, pyrogenic reactions, adverse health effects, or other patient safety risks. Healthcare professionals, distributors, and retailers are therefore advised to immediately cease distribution and use of the affected batches and ensure their prompt recall from the market.
    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.

      34- Recall Alert- DTL Sindh declared Substandard Auto Disable Syringes

      Salateen Philip Recall Alerts

      Recall Alert

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      MEDICAL DEVICES DECLARED SUBSTANDARD BY PROVINCIAL LABORATORIES
      DRAP Alert NoNo I/S/06-26-34
      Action Date08 June, 2026
      Target Audience– National Regulatory Field Force.
      – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
      – General Public
      Problem / Issue Drug Testing Laboratory Sindh, Karachi has informed the Drug Regulatory Authority of Pakistan that samples of the below-mentioned medical devices have been declared “Substandard” due to failure of the Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).

      Therapeutic Goods (s) Affected: –

      S#Product NameManufacturer / Importer & AddressBatch No.Remarks
      1Clinic Auto Disable Syringe 3ml (MDMR-000115)M/s Surgi Plast Pvt. Ltd., Plot # 78, Road No. L-4, Industrial Estate Gadoon Amazai, Swabi, Khyber Pakhtunkhwa, Pakistan (ELM # 0030)3-01B-26Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).
      2.Medi Aqua Auto Disable Syringe 3ml (MDMR-000145)M/s Frontier Pharmaceutical (Pvt.) Ltd., (ELM # 0042) W-10, Industrial Estate, Jamrud Road, Peshawar, PakistanAD1B25Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).
      3.Ultra Fine SMD Painless 3ml Syringe (MDMR-000229)M/s Sehat Medical Devices (Pvt.) Ltd., Plot # 473, Sundar Industrial Estate, Lahore, Pakistan (ELM # 0065)3088CL &
      3090CL & 3013DC      		Declared Substandard on the basis of failure of Self-Destructive Performance / Auto-Disability Test (re-use prevention feature).
      Risk Statement:Auto-disable and auto-destruct syringes are designed to become permanently inoperable after a single use. Failure of the self-destructive mechanism may permit reuse of the device, increasing the risk of transmission of blood-borne pathogens Auto-disable and auto-destruct syringes are designed to become permanently inoperable after a single use. Failure of the self-destructive mechanism may permit reuse of the device, increasing the risk of transmission of blood-borne pathogens including Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV). Reuse of such defective syringes may also result in cross-contamination, healthcare-associated infections and serious public health consequences, particularly during immunization programmes and other invasive medical procedures.
      Action InitiatedThe field force of DRAP and Provincial Drug Control Departments has been directed to immediately conduct market surveys for detection of presence and removal of the affected batches from the market. Manufacturers, importers and distributors have been directed to initiate recall of the affected batches in accordance with applicable regulatory requirements.
      Advice for Healthcare ProfessionalsDRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above mentioned batches of the drug product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse
      Event Reporting Form or online through this link.  Further information of reporting problems to DRAP is available on this link.
      Advice for Pharmacies/Medical stores: –All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying the above-mentioned batches. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units should also increase surveillance in the market to ensure effective recall of the affected products.
      Advice for ConsumersConsumers and healthcare facilities in possession of the affected batches should immediately stop using these products and contact the supplier, distributor or manufacturer for return or replacement. Any adverse event or quality issue associated with the use of these products should be reported to DRAP/National Pharmacovigilance Centre.

        33. Rapid Alert – SPURIOUS DRUG PRODUCTS (NOVIDAT 500MG Tablets and TONOFLEX-P Tablets)

        Salateen Philip Recall Alerts
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        Rapid Alert

        SPURIOUS DRUG PRODUCTS (NOVIDAT 500MG Tablets and TONOFLEX-P Tablets)
        DRAP Alert NoNo I/S/06-26-33
        Action Date03 June, 2026
        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 test and analysis reports from the Provincial Drug Testing Laboratory, Punjab, regarding the following drug products sampled from the market. The laboratory has declared the products Spurious under Section 3(zb)(i) of the Drugs Act, 1976. Further investigation conducted by the manufacturer, SAMI Pharmaceuticals (Pvt.) Ltd., confirmed that the products were not manufactured by the company and are falsified/spurious.
        S#Product NameBatchManufacturerRemarks
        1NOVIDAT 500mg Tablets Ciprofloxacin HCl equivalent to Ciprofloxacin 500mg (Reg. No. 011837)139N086Purportedly manufactured under license of SAMI Pharmaceuticals (Pvt.) Ltd., KarachiSpurious. Assay result showed 0.00 mg/tablet against the stated strength of 500 mg/tablet.
        2TONOFLEX-P Tablets Tramadol HCl 37.5mg + Paracetamol 325mg (Reg # 067163)248N105Spurious. Assay results showed 0.00 mg/tablet for both active ingredients against the stated strengths of 37.5 mg and 325 mg, respectively.
        Risk StatementThe presence of spurious medicines containing no detectable active pharmaceutical ingredients poses a serious risk to public health due to treatment failure, disease progression, and potential harm to patients relying on these products. Healthcare professionals and supply chain stakeholders are advised to remain vigilant and immediately report any information regarding the availability or distribution of the above-mentioned batches.
        Action InitiatedThe Regulatory Field Force of DRAP and Provincial Drug Control Departments has been directed to conduct surveillance activities throughout the supply chain to confiscate the falsified products.
        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.