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Month: March 2026

10. Rapid Alert – Spurious Injection RHOPHYLAC 300 µg (Batch # P100707423)

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Rapid Alert

SPURIOUS INJECTION RHOPHYLAC 300 µg (BATCH NO. P100707423)
DRAP Alert NoNo I/S/03-26-10
Action Date11 March, 2026
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDrug Testing Laboratory (DTL), Punjab vide Test Report No. 01-105012931/DTL dated 06-02-2026 has declared the following sample as Spurious under Section 3(zb)(ii) of the Drugs Act, 1976. The product is purported to be manufactured by M/s CSL Behring AG, Switzerland and imported/distributed by M/s Hakimsons (Impex) (Pvt.) Ltd., Karachi; however, verification from the stated importer confirms that the recovered batch does not belong to them and was not legally imported.
The sample also failed Sterility Test (Membrane Filtration Method) and was additionally categorized as Substandard on sterility grounds and Misbranded with respect to labeling.
S#Product NameBatch No.Manufacturer (as per label)Test Result
1Injection Rhophylac 300 µg (Human Anti-D (Rh) Immunoglobulin) Prefilled Syringe 2 ml (1500 IU / 300 µg)P100707423Purported to be manufactured by: M/s CSL Behring AG, Switzerland Imported/Distributed by: M/s Hakimsons (Impex) (Pvt.) Ltd., KarachiDeclared Spurious, Misbranded & Substandard (Sterility Failure)
Risk StatementThe product is a Human Anti-D (Rh) Immunoglobulin injection indicated for prevention of Rh isoimmunization in Rh-negative individuals. Laboratory testing revealed microbial growth in sterility testing, indicating contamination and rendering the product unsafe for parenteral administration. Additionally, the batch has been confirmed as falsified and not legally imported by the authorized distributor. Administration of this contaminated and spurious biological product may lead to serious bloodstream infections, therapeutic failure in prevention of Rh sensitization, and life-threatening complications. The public health risk is assessed as high, particularly for pregnant women and immunocompromised patients.
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.

09. Rapid Alert – SPURIOUS CEFIXIME 400mg CAPSULE (Batch # LLM034)

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Rapid Alert

SPURIOUS CEFIXIME 400 mg CAPSULE (BATCH NO. LLM034)
DRAP Alert NoNo I/S/03-26-09
Action Date11 March, 2026
Target Audience1. Regulatory Field Force of DRAP and Provincial Drug Control departments.
2. Healthcare Professionals
3. Pharmacies and medical stores
Problem StatementDrug Testing Laboratory (DTL), Punjab has declared following sample of product as ‘Spurious’ purported to be manufactured/marketed by the stated manufacturer, however, upon laboratory analysis and comparison with the genuine QC retention sample, it has been determined that the product is not the authentic product of the registered manufacturer and is therefore classified as spurious under the Drugs Act, 1976.

Following product is being marketed and sold in Pakistan without prior registration/enlistment with the Drug Regulatory Authority of Pakistan (DRAP)

S#Product NameBatchManufacturerTest Result
1Capsule CARICEF Cefixime Trihydrate equivalent to Cefixime …………400 mg (Reg # 022416)LLM034Purported to be manufactured by: M/s Healthtek (Pvt.) Ltd., Plot No. 14, Sector 19, Korangi Industrial Area, Karachi Marketer SAMI Pharmaceuticals (Pvt.) Ltd., F-95, S.I.T.E., KarachiDeclared Spurious
Risk StatementThe subject product has been declared Spurious, as laboratory analysis confirmed absence of the stated active ingredient (Cefixime), resulting in complete therapeutic failure. Packaging comparison with the genuine manufacturer’s QC retention sample revealed significant discrepancies in printing, hologram security features, blister demarcation, and labeling details, confirming it is not an authentic product. Use of this falsified antibiotic may lead to disease progression, complications, and increased antimicrobial resistance. The risk to public health is assessed as high, particularly for patients requiring effective antibacterial therapy.
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.

08. Recall Alert (Class-II) – DTLs punjab declared substandard drug products.

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Recall Alert

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DRUG PRODUCT DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES, PUNJAB.
DRAP Alert NoNo II/S/03-26-08
Action Date11 March, 2026.
Target Audience– National Regulatory Field Force.
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue Drug Testing Laboratories of Punjab Province informed that the samples of below mentioned drug products have been declared as ‘Substandard ’.

Therapeutic Goods (s) Affected: –

S#Product NameBatch No.ManufacturersRemarks
1.Tablet Sapizine 10 mg  Each Tablet Contains: Cetrizine Dihydrochloride 10mg (Reg # 054261)13208M/s Sapient Pharma. 123-S Industrial Area Kot Lakhpat Lahore. (DML # 000207)The sample has been declared “substandard” on the basis of organic impurities.
Risk Statement:Tablet Sapizine 10 mg (Cetirizine Dihydrochloride 10 mg) has been declared sub-standard due to the presence of organic impurities beyond acceptable pharmacopeial limits. Elevated organic impurities may indicate degradation, poor manufacturing control, or inadequate storage conditions, potentially leading to reduced potency, altered pharmacological effect, or increased risk of adverse reactions such as hypersensitivity or gastrointestinal disturbances.
The population most likely to be affected includes general out-patient users, particularly children, elderly patients, and individuals with allergic rhinitis, urticaria, or other hypersensitivity conditions relying on consistent antihistaminic therapy. Although cetirizine is not a life-saving drug, compromised quality may result in therapeutic failure and unnecessary exposure to impurities.
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.

    07. Recall Alert (Human) – DTLs Punjab declared substandard drug products.

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    Recall Alert

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    DRUG PRODUCT DECLARED SUBSTANDARD & ADULTERATED BY DRUG TESTING LABORATORIES, PUNJAB.  
    DRAP Alert NoNo I/S/03-26-07
    Action Date11 March, 2026.
    Target Audience– National Regulatory Field Force.
    – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
    – General Public
    Problem / Issue Drug Testing Laboratories of Punjab Province informed that the samples of below mentioned drug products have been declared as ‘Substandard & Adulterated’.

    Therapeutic Goods (s) Affected: –

    S#Product NameBatch No.ManufacturersRemarks
    1.Injection SORIDE Each mL contains: Sodium Chloride USP….9mg (Reg # 044017)SR260004M/s Bosch Pharmaceuticals (Pvt) Ltd. 221 Bosch House Sector 23 Korangi industrial Area Karachi.  (DML # 000350)The sample is declared as “Misbranded” under Section 3(s)(iv) of the Drugs Act, 1976 due to non-compliance with USP labelling requirements (osmolar concentration not stated on the label as required). The sample is also declared “Sub-Standard” on the basis of visible particulates in injection.
    2.Injection Neudex Each ml contains: Dexamethasone sodium phosphate eq. to dexamethasone phosphate……4mg (Reg #  042943)DX030M/s Neutro Pharma (Pvt) Ltd. 9.5-Km Sheikhupura Road Lahore. (DML # 000576)The above sample is Adulterated as per The Drugs Act 1976, 3 (a)(iv) on the basis of Identification and Quantification of Dexamethasone (base).  
    Risk Statement:The cited products, Injection SORIDE (Sodium Chloride 0.9%) and Injection Neudex (Dexamethasone Sodium Phosphate 4 mg/mL), present significant clinical and regulatory risk. SORIDE has been declared misbranded due to non-compliance with USP labeling requirements (absence of osmolar concentration), which may lead to improper clinical use in sensitive populations such as neonates, critically ill, or electrolyte-imbalanced patients. More critically, the presence of visible particulates in a parenteral preparation classifies it as sub-standard, posing a direct risk of embolism, phlebitis, pyrogenic reactions, and systemic inflammatory responses.
    Injection Neudex has been declared adulterated based on failure in identification and quantification of dexamethasone (base), indicating potential presence of incorrect strength, substitution, or degradation. This may result in therapeutic failure in emergency conditions such as anaphylaxis, cerebral edema, severe asthma, or shock, where corticosteroids are life-saving.
    The population most likely to be affected includes hospitalized patients, emergency cases, pediatric and ICU patients receiving IV fluids or corticosteroid injections. The overall risk level is assessed as high, particularly because both products are injectable formulations administered systemically, and any quality defect may result in immediate and serious patient harm.
    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.

      06. Recall Alert (Veterinary) – DTLs punjab declared substandard products.

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      Recall Alert

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      VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

      DRAP Alert NoNo I/S/03-26-06
      Action Date11 March, 2026.
      Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments.
      ·         Healthcare Professionals-Veterinarians
      ·         Farmers/consumers
      Problem / Issue Drug Testing Laboratories, Punjab informed that the sample of below mentioned Veterinary Drug products have been declared as ‘Substandard’.

      Therapeutic Goods (s) Affected: –

      S#Product DetailsBatchManufacturer detailsRemarks
      1Injection. Penbiotic. Each vial contains: Benzyl Penicillin 500,000 I.U. Procaine Penicillin 1,500,000 I.U. Streptomycin Sulphate 5GM (Reg # 022148)  V02856M/s Nawans Laboratories (Pvt) Ltd. 136 Sector 15 Korangi Industrial Area Karachi.  (DML # 000442)The sample is Sub-Standard with regards to Assay andSterility  Test for related substances.
      2.Injection Ivovectin 2% Each ml contains: Ivermectin …. 20 mg (Reg # 079289)2523216M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)Declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances.
      3.Injection CYANORAS Each ml contains: Cyanocobalamin …. 25 mcg (Reg. # 109953)CYN-009M/s Ras Pharmaceuticals (Pvt) Ltd. 25-Km Lahore Road Multan. (DML # 000821)Declared as “Sub-Standard” on the basis of Assay test and Bacterial Endotoxins Test.
      4.Injection Ivergen 1% 50ml Each ml contains: Ivermectin …… 10 mg (Reg # 023432)605.IVM/s Symans Pharmaceuticals (Pvt.) Ltd. 10-Km Sheikhupura Road Lahore. (DML # 000323)Declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances.
      5.Injection Ivozon 1% Each ml contains: Ivermectin …… 10 mg (Reg # 119702)AP/RCB-024M/s. Amazon Pharmaceutical (Pvt) Ltd. Plot No. 10/A & 29/B, Small Industrial Estate, Bhimber, AJK  (DML # 000975)The sample is declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances.
      6.Injection. SUPERMEC 10ML Each ml contains: Ivermectin …… 10 mg (Reg # 075601)5773M/s Mylabs (Pvt) Ltd.  Khanka Sharif Tehsil and District Bahawalpur (DML # 000747)The sample is declared as “Sub-Standard” on the basis of Assay Test and Chromatographic Purity Test.
      7.Injection Ivotek Each ml contains: Ivermectin …… 10 mg (Reg # 016284)VM398M/s Star Laboratories (Pvt) Ltd.  23 Km Multan Road Lahore. (DML # 000130)Declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances.
      Risk Statement:The above-mentioned products, comprising parenteral veterinary and antimicrobial injections including Benzyl/Procaine Penicillin with Streptomycin, Ivermectin (multiple brands), and Cyanocobalamin, have been declared sub-standard on critical quality parameters such as Sterility, Assay, Related Substances, Bacterial Endotoxins, and Chromatographic Purity. Failure in sterility and endotoxin testing (particularly for Penbiotic and CYANORAS injections) poses a serious and immediate risk of septicemia, pyrogenic reactions, and treatment failure, while assay deviations and related substance impurities in multiple ivermectin products may result in under-dosing, toxicity, antimicrobial resistance, or therapeutic inefficacy. The population most likely to be affected includes livestock animals (cattle, buffaloes, sheep, goats, and poultry) receiving these veterinary injections, with indirect risk to farmers, dairy/meat consumers, and the general public through potential antimicrobial resistance development and compromised food safety.
      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 VeterinarianThis alert applies strictly to the specific batches listed above and does not apply to other batches of the same products. Veterinarians are therefore advised not to prescribe, administer, or stock these identified batches under any circumstances. In case any of the above-mentioned batches have already been administered, treated animals should be closely monitored for possible signs of infection, treatment failure, or adverse reactions, and appropriate supportive care must be provided. Any suspected adverse events or quality-related problems linked to these batches should be reported immediately to DRAP’s Pharmacovigilance Centre and to the Provincial Livestock & Dairy Development Departments. Practitioners are further advised to ensure that only alternative registered and quality-assured batches are used in veterinary practice.
      Advice for Farmers and Livestock OwnersFarmers and livestock owners are advised to immediately stop using the affected batch and isolate all remaining stock. Closely monitor treated animals for fever, swelling at the injection site, reduced appetite, or any sudden illness, and consult a veterinarian if such symptoms appear. Until animals are clinically stable, avoid selling or using milk or meat from visibly unwell animals. The affected product should be returned to the supplier or distributor according to recall instructions. Farmers are further advised to maintain proper records of batch numbers, treatment dates, and suppliers for traceability, and to ensure that only sterile, approved veterinary injections are used and stored under recommended conditions.