Year: 2025

112. Recall Alert (Class-I) – Veterinary Drug Products (Substamdard)

Salateen Philip Recall Alerts November 18, 2025November 18, 2025Recall

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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)

Salateen Philip Recall Alerts November 18, 2025November 18, 2025Recall

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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)

Salateen Philip Recall Alerts November 17, 2025November 17, 2025Recall

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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)

Salateen Philip Recall Alerts November 17, 2025November 17, 2025Recall

Recall Alert

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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.

Training on Software for Electronic Submission of Applications for Quota Allocations and Functions of Controlled Drugs Division

Abdul Qadir Events November 14, 2025November 14, 2025

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Draft Guideline for Lot Release of Human Vaccines, Blood Products (Plasma Derivatives Medicinal Products) and Anti-Sera (Edition 03)

Abdul Qadir Uncategorized November 13, 2025November 13, 2025

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Decisions of the 105th Meeting of the Medical Device Board (MDB) held on 23-10-2025 (Manual Applications)

Abdul Qadir Medical Devices Board November 13, 2025

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108. Recall Alert (Veterinary Drug Product) – Melovetz 10 Injection (Batch # 2599063)

Salateen Philip Recall Alerts November 12, 2025November 12, 2025Recall

Recall Alert

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VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY, KARACHI.

DRAP Alert No	No I/S/11-25-108
Action Date	12 November, 2025.
Target Audience	·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments. ·         Healthcare Professionals-Veterinarians ·         Farmers/consumers
Problem / Issue	Central Drugs Laboratory Karachi informed that the sample of below mentioned Veterinary product has been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1.	Melovetz 10 Injection  Each 100 ml Contains: Meloxicam (B.P) ……. 10mg (Reg # 102021)	2599063	M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)	Sample is Sub-Standard on the basis “Sterility test”.

Risk Statement:	Use of a non-sterile injectable veterinary preparation may cause local abscesses, septicemia, or systemic infections in treated livestock, leading to reduced productivity, illness, or death in affected animals. Such contamination also poses an indirect public health risk through the potential presence of harmful microorganisms or residues in milk and meat intended for human consumption. Therefore, the affected batch poses a significant risk to animal and public health and requires immediate recall and segregation from all levels of the 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 batch listed above and does not apply to other batches of the same product. Veterinarians are therefore advised not to prescribe, administer, or stock these identified batch under any circumstances.
Advice for Farmers and Livestock Owners	Farmers and livestock owners are advised not to use the affected batch of Melovetz 10 Injection (Batch No. 2599063) on their animals. Use of a non-sterile veterinary injection may cause swelling, abscess formation, fever, or serious infection in treated livestock. If any animals have recently been injected with this product and show unusual signs of illness, weakness, or loss of appetite, discontinue use immediately and consult a qualified veterinarian. The remaining stock of the affected batch should be returned to the supplier, distributor, or local veterinary office. Farmers are further advised to purchase veterinary medicines only from authorized sources, ensure that the packaging carries valid registration and batch details, and always check the expiry date and product integrity before use. Proper recordkeeping of veterinary products and prompt reporting of any suspected quality issues to the Provincial Livestock Department or DRAP are strongly encouraged to protect animal and public health.

107. Recall Alert – (Class-I) Injection Isobaj (Batch # IB-0925)

Salateen Philip Recall Alerts November 12, 2025November 12, 2025Recall

Recall Alert

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DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

DRAP Alert No	No I/S/11-25-107
Action Date	13 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.	Isobaj Injection 10ml Each ml contains: Isosorbide Dinitrate ……. 1mg (Reg # 100721)	IB-0925	M/s Bajwa Pharmaceuticals (Pvt) Ltd. 36-Km Lahore Gujranwala Road Khori District Sheikhupura. (DML # 000805)	Sample is Sub-Standard on the basis “Bacterial Endotoxin test”.

Risk Statement:	The sample of Isobaj Injection 10 mL (Batch No. IB-0925) has been declared “Substandard” on the basis of failure in the Bacterial Endotoxin Test, indicating the possible presence of pyrogenic contamination. Use of such injectable preparations may cause fever, chills, hypotension, or severe adverse reactions, particularly in hospitalized, cardiac, or elderly patients for whom this product is commonly prescribed. As the defect directly affects the safety and quality of the product, the batch poses a high public-health risk and warrants an immediate Class I recall, with retrieval of all distributed stock to prevent potential harm to patients.
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.

106.Recall Alert – (Class-III) Tablet Cekamol 500 mg (Batch # T-5014)

Salateen Philip Recall Alerts November 12, 2025November 12, 2025Recall

Recall Alert

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert No	No III/S/10-25-106
Action Date	12 November, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratory from Province informed that the sample of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Tablet Cekamol 500 mg Each Tablet Contains: Paracetamol ……. 500 mg (Reg. # 004268)	T-5014	M/s CKD Pharmaceuticals Pakistan (Pvt) Ltd. 50/28 Korangi Industrial Area Karachi. (DML # 000144)	The sample is “Substandard” with respect to physical characteristics observed. (White colored, round shaped, flat tablet with bevelled edges, have score line on one side and other side is engraved with “CKD”, packed in ALU/PVC blister of 1*10’s. Mmanufacture Sspecification claims that tablet should be round, flat and plain from both sides.)

Risk Statement:	The sample of Tablet Cekamol 500 mg (Batch No. T-5014) has been declared “Substandard” with respect to its physical characteristics, as the tablets bear engraving and a score line inconsistent with the approved product specifications. Although this deviation does not affect the safety, strength, or efficacy of the medicine, it indicates non-compliance with Good Manufacturing Practices (GMP) and approved appearance standards. The defect poses no direct risk to patient health; however, recall of the affected batch is recommended to maintain product quality and regulatory compliance.s.
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.

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