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03. Recall Alert (Class-I) – Veterinary Drug Products reports from DTLs Punjab.

Salateen Philip Recall Alerts

Recall Alert

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VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert NoNo I/S/02-26-03
Action Date12 February, 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 DetailsBatch #Manufacturer detailsRemarks
1Injection. I-PENRIT-5 Each vial contains Procaine Penicillin…..1500000 iu, Benzyl Penicillin……500000 iu, Streptomycin Sulphate….5 gm (Reg # 079517)AM-164M/s International Pharma Labs. Raiwind Road Bhobtian Chowk Defence Road 1-Km Toward Kahna, Lahore. (DML # 000582)The sample is Sub-Standard with regards to Sterility Test .
2Duralin 50 Injection OXYTETRACYCLINE ……..50MG/ml (Reg # 078206)5782M/s Mylabs (Pvt) Ltd. Khanka Sharif Tehsil and District Bahawalpur. (DML # 000747)The sample is Misbranded with regards to labelling as defined under Section 3(s)(iv) of the Drugs Act,1976 and Substandard on the basis of Sterility Test.  
3.Ivotek Injection Ivermectin 10 mg/ml (Reg # 016284)VM583M/s Star Laboratories (Pvt) Ltd. 23 Km Multan Road Lahore. (DML # 000130)The sample is Sub-Standard with regards to Related substance.
4.Oxytovetz injection 50 ml Oxytocin 10IU/ML25129681M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)The sample is Sub-Standard with regards to Sterility Test & Assay test .
Risk Statement:These veterinary medicines present a moderate to high risk, primarily affecting livestock health and indirectly the general public. Substandard sterile injectable antibiotics (Penicillin/Streptomycin and Oxytetracycline) failing sterility tests may cause severe infections, abscess formation, treatment failure, and animal deaths, particularly in dairy cattle, poultry, and farm animals. Misbranding and quality defects can also lead to incorrect dosing and misuse by farmers and veterinarians. Substandard ivermectin with related substance issues may reduce effectiveness against parasites and increase the risk of drug resistance. Oxytocin injection failing sterility and assay tests is of serious concern as it is used during animal delivery and milk production, potentially causing reproductive complications and economic loss. The most likely to be affected are farmers, veterinarians, dairy producers, and consumers, due to possible consequences such as reduced food safety, antibiotic residues in milk/meat, and public exposure through the food supply chain.
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.

    02. Recall Alert (Class-II) – Drug Products tested by DTL Punjab

    Salateen Philip Recall Alerts

    Recall Alert

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    DRUG PRODUCT DECLARED SUBSTANDARD & ADULTERATED BY DRUG TESTING LABORATORIES, PUNJAB.  
    DRAP Alert NoNo II/S/02-26-02
    Action Date12 Febraury, 2025.
    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.TABLET ASCARD-75 Each enteric coated tablet contains: Acetylsalicylic Acid (Aspirin) 75mg (Reg # 016600)AR065L, AR047LM/s Atco Laboratories Limited. B-18 S.I.T.E Karachi. (DML # 000188)The sample has been declared “Substandard” with respect to test performed for “Related Substances”
    2.Tablet Daisy 10 mg Each film coated tablet contains: Cetirizine dihydrochloride USP 10mg (Reg # 032865)  24F213M/s Mega Pharmaceuticals Ltd. 27 Km Raiwind Road Lahore (DML # 000537)The sample has been declared “Sub-Standard” with regards to Impurities Tests.
    3.Tablet Sapizine 10 mg Each Tablet Contains: Cetrizine Dihydrochloride 10mg (Reg # 054261)  13098M/s Sapient Pharma.  123-S Industrial Area Kot Lakhpat Lahore. (DML # 000207)The sample has been declared “Sub-Standard” with regards to Impurities Tests.
    4.Tablet Rozen 10mg Each Tablet Contains: Cetrizine Dihydrochloride 10mg (Reg # 040161)5F006M/s Rasco Pharma (Pvt) Ltd.  5.5 Km Raiwind Road Ali Razabad, Lahore. (DML # 000530)The sample has been declared “Sub-Standard” with regards to Impurities Tests.
    5.Cream Kanadex-N Each gram contains: Dexamethasone-21 phosphate in the form of disodium salt 1mg Neomycin in the form of sulphate 3500I.U (Reg # 012475)17-54, C8-26M/s ISIS Pharmaceutical & Chemical Works. 25/1-3 Sector 12-C North Karachi Industrial Area Karachi. (DML # 000126)The sample is declared “Substandard” on the basis of the assay of Dexamethasone Phosphate (as disodium salt), and “Adulterated” on the basis of the identification and quantification of Dexamethasone (base) in HPLC analysis (which is an undeclared active pharmaceutical ingredient not stated on the product label.
    Risk Statement:These products present a moderate to high public health risk, mainly affecting the general outpatient population, especially cardiac patients, allergy sufferers, children, and chronic medicine users. Substandard aspirin (Ascard-75) with excessive related substances may increase the risk of gastrointestinal irritation, bleeding, or reduced cardiovascular protection in patients using it for long-term prevention of heart attack or stroke. Multiple cetirizine brands failing impurity tests could expose the public—particularly children and individuals with liver or kidney compromise to unexpected toxic effects or reduced safety margins, even though the medicine is generally used for minor allergic conditions. The highest concern is Kanadex-N cream, where adulteration with an undeclared corticosteroid base can lead to misuse, skin thinning, hormonal suppression, masking of infections, and serious harm in infants or prolonged users, making dermatology patients and self-medicating consumers the most likely to be affected.
    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.

      01. Recall Alert (Class-I) – Drug Products tested by DTL Punjab.

      Salateen Philip Recall Alerts

      Recall Alert

      Download
      DRUG PRODUCT DECLARED SUBSTANDARD & ADULTERATED BY DRUG TESTING LABORATORIES, PUNJAB.  
      DRAP Alert NoNo I/S/02-26-01
      Action Date12 Febraury, 2025.
      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.PSOL 2 ml .
      Sterile water for injection  
      (Reg. # 098431)      		AK144M/s Pharmasol (Pvt) Ltd.
      Plot 549, Sunder Industrial estate, Lahore. (DML # 000872)      		The sample has been declared “Substandard” with respect to Endotoxin test performed.
      2.Nafen Ophthalmic Suspension
      Each ml conatins:
      Nepafenac 1 mg
      (Reg # 075907)        		4231M/s Helix Pharma (Pvt) Ltd.
      A/56 SITE Mangopir Karachi. (DML # 000030)      		The sample has been declared “Substandard” on the basis of Sterility test.
      3.Metrorise Infusion
      Metronidazole….500mg/100ml
      (Reg # 040412-D)      		LV-2506M/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.  
      4.Metroin Infusion IV
      Metronidazole….500mg/100ml
      (Reg # 071279)      		MT25-331M/s Saturn Pharmaceuticals (Pvt) Ltd. 
      23-Km, Thokar Raiwind Road Lahore. (DML # 000734)        		The sample has been declared “Substandard” on the basis of Bacterial Endotoxin Test.
      5.Satamin Injection
      Mecobalamin………500mcg
      (Reg #  071284)      		MC24-022,  MC24-023,  MC24-026,  MC25-001M/s Saturn Pharmaceuticals (Pvt) Ltd. 
      23-Km, Thokar Raiwind Road Lahore. (DML # 000734)        		The sample has been declared Substandard on the basis of Assay test and Adulterated on the Quantification of Cyanocobalamin.
      Risk Statement:These findings indicate a high public health risk, primarily affecting hospitalized patients and vulnerable groups. The most likely to be harmed are neonates, children, elderly patients, immunocompromised individuals, post-surgical patients, and those receiving IV therapy or ophthalmic treatment. Substandard sterile water and infusions failing endotoxin/sterility tests can lead to serious bloodstream infections, septic shock, pyrogenic reactions, and even fatalities, especially in intensive care settings. The presence of visible particles further increases the risk of embolic or inflammatory complications. The adulteration and incorrect potency in Satamin injection may result in therapeutic failure, delayed neurological recovery, or unexpected adverse effects, undermining patient safety. Overall, these products pose the greatest risk in clinical and emergency care environments, where sterile injectable medicines are critical.
      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.