Month: November 2025
Decisions of the 107th Medical Device Board (MDB) Meeting: Manual Applications (Part II)
Decisions of the 106th Medical Device Board (MDB) Meeting: Manual Applications (Part II)
114. Recall Alert (Class-I) – Injection Cyanofar 50ml (Veterinary) – Substandard
Recall Alert
VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG LABORATORIES, KARACHI.
| DRAP Alert No | No I/S/11-25-114 |
| Action Date | 21 November, 2025. |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers |
| Problem / Issue | Drugs Testing Laboratories from Provinces informed that the sample of below mentioned Veterinary Drug products have been declared as ‘Substandard ’. |
Therapeutic Goods (s) Affected: –
| S# | Product Details | Batch # | Manufacturer details | Remarks |
| 1. | Injection Cyanofar 50 ml Each ml Contains: Cyanocobalamin….125mcg (Reg. # 074745) | CY-2431 | M/s Izfaar Pharmaceutical Industries. 542/A-B Sunder Industrial Estate Lahore (DML # 000800) | The above sample is “Sub-Standard”, on the basis of Sterility Test performed as per USP. |
| Risk Statement: | The above veterinary injectable product has been declared Substandard due to failure in the Sterility Test, indicating a risk of microbial contamination. Use of a non-sterile injectable in animals may lead to serious infections, treatment failure, or mortality. Livestock farmers, dairy producers, veterinarians, and animal handlers are the groups most likely to be affected, as contaminated therapy can result in animal illness, reduced productivity, economic losses, and potential downstream public-health concerns linked to milk and meat 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 Veterinarian | This 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 Owners | Farmers 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. |
113. Recall Alert (Class-I) – Substandard Drug Products (Human)
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.
| DRAP Alert No | No I/S/11-25-113 |
| Action Date | 20 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 Name | Batch No. | Manufacturers | Remarks |
| 1. | Injection Freclomide Each Ampoule contains Metoclopramide HCl ……10mg (Reg. # 071331) | 25MC09 | M/s Friends Pharma (Pvt) Ltd. 31-Km Ferozepur Road Lahore. (DML # 000531) | The above sample is Sub-Standard on the basis of “Particulate contamination: visible particles” performed as per BР. |
| 2. | Infusion SAFEMED Each 100ml contains: Metronidazole ……….. 500mg (Reg. # 045824) | SAU-2501 | M/s Ahad International Pharmaceutical Limited. 13-Km Gomal University Multan Road Dera Ismail Khan. (DML # 000433) | The above sample is Sub-Standard, on the basis of Particulate contamination: visible particles performed as per BP. |
| 3. | Tablet Loratamin Each Tablet Contains: Loratadine …. 10mg (Reg. # 062647) | 23 | M/s Murfy Pharmaceuticals (Pvt) Ltd. 8-Km Raiwind Road Lahore. (DML # 000543) | The sample is “Adulterated” as defined under clause (iv) of sub-section (a) of section 3 of The Drugs Act, 1976 as it contains “Paracetarmol” as an ingredient a substance other than the prescribed substance i.e., Loratadine. |
| Risk Statement: | All three products present a high public health risk due to critical quality defects. Injection Freclomide and Infusion SAFEMED contain visible particulate contamination, which can lead to severe reactions such as embolism, sepsis, organ damage, or death, especially when administered intravenously. Tablet Loratamin is adulterated with Paracetamol, exposing patients to incorrect therapy, potential allergic reactions, and failure to treat the intended condition. The population most likely to be affected includes acutely ill patients in hospitals, emergency departments, and general public using these medicines for routine treatment, placing them at a heightened risk of adverse outcomes due to compromised product quality. |
| 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 Professionals | DRAP 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. |
112. Recall Alert (Class-I) – Veterinary Drug Products (Substamdard)
Recall Alert
VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG LABORATORIES, KARACHI.
| DRAP Alert No | No I/S/10-25-111 |
| Action Date | 18 November, 2025. |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers |
| Problem / Issue | Drugs Testing Laboratories from Provinces informed that the sample of below mentioned Veterinary Drug products have been declared as ‘Substandard ’. |
Therapeutic Goods (s) Affected: –
| S# | Product Details | Batch # | Manufacturer details | Remarks |
| 1. | Injection Antil 50 ml Each ml Contains: Pheniramine maleate …… 11.35mg (Reg. # 074750) | AN-2520 & AN-2519 | M/s Izfaar Pharmaceutical Industries. 542/A-B Sunder Industrial Estate Lahore (DML # 000800) | The sample is declared as “Sub-Standard” on the basis of Assay Test and Sterility Test. |
| 2. | Injection Mac Rold 2% 50 ml Each ml contains: Ivermectin …. 20 mg (Reg # 106810) | YI-140 | M/s Haarlods Pharmaceuticals (Pvt) Ltd. Plot No.60-64/C, Small Industrial Estate, Bhimber, AJK. (DML # 000921) | The sample is declared as “Sub-Standard” on the basis of Assay Test and Related substances. |
| Risk Statement: | The above veterinary injectable products have been declared Substandard on the basis of critical quality failures, including Assay, Chromatographic Purity/Related Substances, and Sterility tests. Use of such defective veterinary injections poses a significant risk of treatment failure, toxicity, adverse reactions, and severe infections in animals. The groups most likely to be affected include livestock farmers, dairy producers, animal handlers, and veterinarians, as compromised product quality may lead to animal morbidity or mortality, reduced productivity, contamination of milk or meat, and consequential economic losses. These defects may also indirectly impact public health, particularly where contaminated or inadequately treated animals enter 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 Veterinarian | This 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 Owners | Farmers, livestock owners, and veterinary practitioners are advised not to use the affected batches of the above-mentioned injectable veterinary products found Substandard due to failures in Assay, Sterility, Chromatographic Purity, and Related Substances tests. Use of such defective injections may result in ineffective treatment, unexpected adverse reactions, infections, toxicity, or deterioration in the animal’s health and productivity. Immediately stop administration, isolate remaining stock, and return it to your supplier or distributor. If any animal has already received these injections, monitor for unusual symptoms such as fever, swelling at the injection site, allergic reactions, or treatment failure, and consult a qualified veterinarian without delay. Livestock handlers, dairy owners, and farmers are further advised to ensure that only quality-assured and properly stored veterinary medicines are used for animals to protect herd health, avoid economic loss, and prevent contamination of milk and meat entering the food chain. |
111. Recall Alert (Class-I) – Veterinary Drug Products (Substandard)
Recall Alert
VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG LABORATORIES, KARACHI.
| DRAP Alert No | No I/S/10-25-111 |
| Action Date | 18 November, 2025. |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers |
| Problem / Issue | Drugs Testing Laboratories from Provinces informed that the sample of below mentioned Veterinary Drug products have been declared as ‘Substandard ’. |
Therapeutic Goods (s) Affected: –
| S# | Product Details | Batch # | Manufacturer details | Remarks |
| 1. | Injection Micrise-1% 10ml Each ml contains: Ivermectin….10 mg (Reg. # 111203) | MR-073 | M/s Biorise Pharmaceuticals. 19-Km, Lahore Road, Multan. (DML # 000934) | The sample is declared as “Sub-Standard” on the basis of Assay Test and Chromatographic Purity Test. |
| 2. | Injection Ivotek Each ml contains: Ivermectin….10 mg (Reg. # 016284) | VM 396 & VM 1301 | M/s Star Laboratories (Pvt.) Ltd. (Animal Health Care Division) 23 Km Multan Road Lahore. (DML # 000130) | The sample is Sub-Standard with regards to Assay and Test for related substances. |
| 3. | Injection Ivergen 10ml Each ml contains: Ivermectin….10 mg (Reg. # 023432) | 578. IV | M/s Symans Pharmaceuticals (Pvt) Ltd. 10-Km Sheikhupura Road Lahore. (DML # 000323) | The sample is Sub-Standard with regards to Assay and Test for related substances. |
| Risk Statement: | The above veterinary injectable ivermectin products have been declared Substandard due to failures in Assay and Chromatographic Purity/Related Substances tests, indicating possible under-potency, over-potency, or presence of harmful impurities. Use of such defective injections may lead to treatment failure, toxic reactions, or unexpected adverse outcomes in animals. The groups most likely to be affected include livestock farmers, veterinarians, animal handlers, and dairy/meat producers, as compromised product quality can result in animal illness, reduced productivity, economic loss, and potential downstream impact on 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 Veterinarian | This 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 Owners | Farmers, livestock handlers, and veterinarians are advised not to use the above-mentioned batches of ivermectin injections, as they have been declared Substandard based on Assay, Chromatographic Purity, and Related Substances tests. Use of such defective products may lead to ineffective treatment of parasites, unexpected reactions in animals, prolonged illness, or production losses in milk- and meat-yielding animals. Immediately stop administering these batches if in possession, segregate and quarantine any remaining stock, and return it to the supplier or distributor. If animals have recently been treated with these batches and show unusual signs such as weakness, poor response to treatment, or adverse reactions then please consult a qualified veterinarian at once. Farmers are also encouraged to verify batch numbers before use, maintain proper purchase records, and obtain products only from licensed veterinary pharmacies or authorized distributors. |
110. Recall Alert (Class-I) – Dexamex Injection (Batch # DX250017)
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.
| DRAP Alert No | No I/S/11-25-110 |
| Action Date | 17 November, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Central Drugs Laboratory informed that the sample of below mentioned drug product has been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Dexamex Injection Each ampoule contains: Dexamethasone sodium Phosphate eq. to Dexamethasone phosphate … 4 mg/ml (Reg # 015896) | DX250017 | M/s Bosch Pharmaceuticals (Pvt) Ltd. 221 Bosch House Sector 23 Korangi industrial Area Karachi. (DML # 000358) | The sample has been declared Substandard on the basis of the Sterility test. |
| Risk Statement: | Use of a non-sterile injectable product may lead to severe infections, including localized abscesses, sepsis, systemic inflammatory reactions, or life-threatening complications, particularly in hospitalized patients, immunocompromised individuals, children, and the elderly, who are more vulnerable to invasive infections. Healthcare professionals, pharmacists, and distributors are strongly advised to immediately stop the use and distribution of the affected batch and take necessary actions for quarantine and recall of the available stock. |
| 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 Professionals | DRAP 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. |
109. Recall Alert (Class-I) – Zayzine Syrup (Batch # 25289)
Recall Alert
DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.
| DRAP Alert No | No I/S/11-25-109 |
| Action Date | 17 November, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | Central Drugs Laboratory informed that the sample of below mentioned drug product has been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Name | Batch No. | Manufacturers | Remarks |
| 1. | Zayzine Syrup Each 5 ml Contains: Cetirizine Dihydrochloride … 5 mg (Reg # 096969) | 25289 | M/s Zaynoon Pharmaceuticals (Pvt) Ltd. 27-28/B, Industrial Estate, Hayatabad, Peshawar (DML # 000358) | The sample has been declared Substandard on the basis of the Assay Test and Physical Description, as the syrup was found to be a clear, colourless liquid in an amber plastic bottle, whereas the manufacturer’s specification describes it as a light green, translucent, viscous, and sugar-free preparation. |
| Risk Statement: | As the product was found to contain excessive amount of the labeled active ingredient and to differ in appearance from the approved specifications. The excessive assay value indicates overdose of Cetirizine Dihydrochloride, which may cause drowsiness, dizziness, headache, or other antihistaminic side effects, particularly in children and sensitive individuals for whom this syrup is commonly prescribed. The defect therefore poses a potential risk to public health, especially in pediatric and allergic patients, and warrants a Class I recall of the affected batch to prevent further exposure and ensure patient 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 Healthcare Professionals | DRAP 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. |