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118. Recall Alert (Class-I) – DTLs Punjab declared Substandard products (Human)

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DRUG PRODUCTS DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES PUNJAB

DRAP Alert NoNo I/S/12-25-118
Action Date08 December, 2025.
Target Audience– National Regulatory Field Force.
– Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
– General Public
Problem / Issue Drug Testing Laboratories Punjab informed that the sample of below mentioned drug product has been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#Product NameBatch No.ManufacturersRemarks
1.AOTILAS 120 ML SUSPENSION Each mL Contains: Domperidone ………. 1 mg (Reg. # 112505)S8B05M/s Astellas Pharmaceutical (Pvt) Ltd.  15-C Industrial Estate Hayatabad Peshawar. (DML # 000677)The sample is “Substandard” as it contains the impurity “Diethylene Glycol” above the permissible limit.
2.Injection. Neudex Dexamethasone Sodium Phosphate eq. to Dexamethasone Phosphate: 4mg/ml (Reg. # 32876)DX032, DX034, DX035 & DX036M/s Neutro Pharma (Pvt) Ltd.  9.5-Km Sheikhupura Road Lahore. (DML # 000576)The sample is declared as “Adulterated” as per section 3 (iv) of The Drugs Act 1976.
Risk Statement:The substandard quality of AOTILAS 120 mL Suspension containing Diethylene Glycol (DEG) above the permissible limit, and the adulterated status of Neudex Injection (Dexamethasone) pose a severe and immediate threat to public health. The populations most likely to be affected include infants, children, elderly patients, pregnant women, and critically ill patients who are prescribed these medicines for gastrointestinal disorders, inflammation, allergic reactions, and emergency medical conditions. Exposure to Diethylene Glycol is highly toxic and may cause acute kidney failure, neurological damage, metabolic acidosis, and death, especially in pediatric patients.
 
The use of an adulterated injectable corticosteroid significantly increases the risk of systemic toxicity, treatment failure, severe infections, shock, and fatal outcomes. Continued availability or use of these products may lead to rapid deterioration of patient health, mass poisoning incidents, irreversible organ damage, and loss of life, representing a highest-level public health emergency requiring immediate recall and strict regulatory enforcement.
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.

    117. Recall Alert (Class-II) – DTLs Punjab Declared Substandard Drug Products.

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    DRUG PRODUCTS DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES PUNJAB.

    DRAP Alert NoNo I/S/12-25-117
    Action Date08 December, 2025.
    Target Audience– National Regulatory Field Force.
    – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
    – General Public
    Problem / Issue Drug Testing Laboratories, Punjab informed that the sample of below mentioned drug products have been declared as ‘Substandard’.

    Therapeutic Goods (s) Affected: –

    S#Product NameBatch No.ManufacturersRemarks
    1.Tablet Virtec 10 mg Each Tablet Contains: Cetrizine Dihydrochloride 10mgFK-25-001M/s Don Valley Pharmaceuticals (Pvt) Ltd. 31-Km Ferozepur Road Lahore. (DML # 000395)The sample is Substandard on the for Organic Impurities, performed as per USP.
    2.Tablet Megadip 5mg Each Tablet Contains: Amlodipine as Besylate ….  5mg (Reg. # 32876)25G337M/s Mega Pharmaceuticals Ltd. 27 Km Raiwind Road Lahore. (DML # 000537)The sample is declared as “Sub-Standard” on the basis of Test for Impurities (Organic Impurities).
    Risk Statement:The substandard quality of Tablet Virtec 10 mg (Cetirizine) and Tablet Megadip 5 mg (Amlodipine) due to failure in organic impurities testing poses a significant risk to public health. The populations most likely to be affected include patients suffering from allergies, hypertension, and cardiovascular diseases, particularly elderly individuals, children, and patients with chronic illnesses who regularly depend on these medicines for symptom control and disease management. The presence of excessive or unidentified organic impurities may lead to reduced therapeutic effect, unexpected side effects, toxic reactions, or long-term health complications. Continuous use of such substandard medicines may result in treatment failure, worsening of disease conditions, hospitalization, and in severe cases, life-threatening outcomes, thereby representing a serious public health concern.
    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.

      116. Recall Alert (Class-II)- Drug Products declared Substandard.

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      DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

      DRAP Alert NoNo I/S/11-25-116
      Action Date27 November, 2025.
      Target Audience– National Regulatory Field Force.
      – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics
      – General Public
      Problem / Issue Provincial Drug Testing Laboratories informed that the sample of below mentioned drug product has 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)  13028M/s Sapient Pharma, 123-S Industrial Area Kot Lakhpat Lahore. (DML # 000207)The sample has been declared substandard on the basis of Impurities Test (Organic Impurities).
      2.Tablet ORTIZIN 10mg Each Tablet Contains: Cetrizine Dihydrochloride …. 10mg (Reg. # 025405)  25C052M/s Obsons Pharmaceuticals.  209-S Industrial Estate Kot Lakhpat Lahore. (DML # 000416)The sample has been declared substandard on the basis of Impurities Test (Organic Impurities).
      Risk Statement:Use of medicines containing excessive organic impurities may lead to reduced therapeutic effect, unpredictable adverse reactions, allergic responses, or toxicity, particularly in sensitive individuals such as children, pregnant women, and elderly patients. Since these products are commonly used for allergy related conditions, a large portion of the public, including patients self-medicating with over-the-counter antihistamines is most likely to be affected. Immediate discontinuation of the affected batches is advised to prevent potential 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.

        115. Recall Alert (Class-I) Veterinary Drug Product declared Substandard.

        Salateen Philip Recall Alerts

        Recall Alert

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        VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG LABORATORIES, KARACHI.

        DRAP Alert NoNo I/S/11-25-115
        Action Date27 November, 2025.
        Target Audience·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments.
        ·         Healthcare Professionals-Veterinarians
        ·         Farmers/consumers
        Problem / Issue Provincial 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 DetailsBatch #Manufacturer detailsRemarks
        1.Tribrissen Injection 48%
        Each 100ml vial contains:
        Trimethoprim, BP…….8%w/v
        Sulfadiazine, BP…..40%
         (Reg. #  091891)        		157884M/s Hilton Pharma (Pvt) Ltd.    Plot No. 13 & 14 Sector 15 Korangi Industrial Area Karachi. (DML # 000543)The sample  sample is Sub-Standard, on the basis Assay and Sterility Tests performed as per BP.
        Risk Statement:Use of a non-sterile or sub-potent veterinary injectable poses a significant risk of severe local infections, fever, systemic illness, treatment failure, and increased mortality in treated animals. Animals receiving ineffective therapy may continue to carry and spread infections, increasing the likelihood of disease transmission within herds. In addition, animals that develop injection-site abscesses or systemic reactions may produce unsafe milk or meat, posing a public-health risk, particularly where veterinary medicines enter the food chain without adequate withdrawal periods. The public most likely to be affected include farmers, livestock handlers, consumers of raw milk/meat, and community’s dependent on these animals for food or livelihood.
        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.