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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

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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.

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

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

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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

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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

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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.

105. Recall Alert – Drug Products for Human Use Declared Substandard

Salateen Philip Recall Alerts October 30, 2025October 30, 2025Recall

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert No	No II/S/10-25-105
Action Date	30 October, 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.	Injection Nidagyl 100ml Metronidazole…500mg/100ml (Reg # 020601)	HM 139	M/s Star Laboratories (Pvt) Ltd. (Human Healthcare Division), 23 Km Multan Road Lahore. (DML # 000130)	The sample is declared as “Adulterated”
2.	Myteka Sachet Each Sachet contains: Montelukast (as sodium) … 4mg (Reg. # 039427)	155321	M/s Hilton Pharma (Pvt) Ltd.   Plot No. 13 & 14 Sector 15 Korangi Industrial Area Karachi. (DML # 000136)	The sample is Sub-Standard on the basis of Impurities Test.
3.	Sterile Water for Injection Water for injection 5ml	WI-132	M/s FYNK Pharmaceuticals.  19-Km Ferozepur Road G.T. Road Kala shah Kaku Lahore. (DML # 000494)	The Sample is Sub-Standard on the basis “Visible particulate matter” as per USP.

Risk Statement:	The use of these defective human drug products poses potential health risks to patients. Injection Nidagyl (Batch HM 139), declared adulterated, may cause treatment failure or toxic reactions in patients receiving parenteral therapy for infections. Myteka Sachet (Batch 155321), found sub-standard due to impurities, may lead to reduced efficacy or adverse effects in pediatric and asthmatic patients commonly using Montelukast. Sterile Water for Injection (Batch WI-132), declared sub-standard due to visible particulate matter, poses a serious risk of embolism or infection in patients where sterility is critical, particularly neonates, elderly, and hospitalized 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.

104. Recall Alert – Veterinary Drug Products Declared Substandard.

Salateen Philip Recall Alerts October 30, 2025October 30, 2025Recall

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

DRAP Alert No	No I/S/10-25-104
Action Date	30 October, 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 products have been declared as ‘Substandard / Misbranded’.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1.	Inj. Genta-Combisone 50ml   Each 100 ml contains: Tylosin Tartrate………. 15 gm Gentamicin Sulphate ….6 gm Dexamethasone ……0.0265 gm Chlorpheniramine…. 0.750 gm (Reg # 046696)	GC-168	M/s Leads Pharma (Pvt) Ltd. Plot No. 81-A Street No. 6 I-10/3 Islamabad. (DML # 000392)	The sample is Sub-Standard with regards to Sterility Test.
2.	Injection Ivergen 10ml Each ml contains: Ivermectin………10 mg (Reg. # 023432)	594.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 use of these defective veterinary injectable products may adversely affect livestock and farm animals, particularly those treated for infections or parasitic infestations. Injection Genta-Combisone poses a risk of microbial contamination due to sterility failure, which can lead to abscesses, septicemia, and reduced milk or meat yield in cattle, buffalo, goats, and other farm species. Injection Ivergen, being sub-standard in assay and related substances, may result in incomplete parasite control, therapeutic failure, and possible drug resistance in treated herds. These defects ultimately endanger the health and productivity of livestock, causing economic losses to farmers and potentially impacting the safety of animal-derived food products consumed by the general public.
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 not to use the affected batches of Injection Genta-Combisone (Batch # GC-168) and Injection Ivergen (Batch # 594.IV) on their animals. The use of non-sterile or sub-standard veterinary injections can cause serious illness, swelling, infection, or treatment failure in cattle, buffalo, goats, and other livestock. If any animals have recently been treated with these products and show signs of fever, swelling at the injection site, weakness, or loss of appetite, stop using the product immediately and consult a qualified veterinarian. Farmers should return the remaining stock to the supplier, distributor, or the nearest veterinary office. They are further advised to purchase veterinary medicines only from authorized dealers and ensure that the products bear clear batch numbers, expiry dates, and registration details issued by DRAP. For continued livestock health and to avoid losses, always store veterinary medicines properly, follow veterinary guidance for dosage, and report any suspected quality-related issues to the Provincial Livestock Department or DRAP through the official complaint channels.

103. Recall Alert – Drug Products Declared Substandard.

Salateen Philip Recall Alerts October 28, 2025October 28, 2025Recall

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert No	No II/S/10-25-103
Action Date	28 October, 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.	Injection Remedy Mecobalamin: 500mcg/ml (Reg. # 040385)	R-2411 & R-2419	M/s Pak Risen Pharmaceuticals Plot No. 3, Block B, Phase I – II, Industrial Estate Hattar. (DML # 000573)	The sample is declared as “Sub-Standard” on the basis of Assay Test & “Adulterated” on the basis of identifying Cyanocobalamin (9.7 mcg/ml).
2.	Injection Neocobal Mecobalamin: 0.5 mg/ML (Reg. # 071447)	S-2825	M/s Pulse Pharmaceuticals (Pvt) Ltd.  Mozay Badoke Raiwind Road (Sua Asil Road) Lahore. (DML # 000564)	The sample is declared as “Sub-Standard” on the basis of Assay Test & “Adulterated” on the basis of identifying Cyanocobalamin (0.106 mg/ml).

Risk Statement:	Administration of these defective injections may result in therapeutic failure, delayed neurological recovery, or persistence of deficiency symptoms, particularly among diabetic, anemic, elderly, and neuropathic patients who rely on Mecobalamin therapy for nerve regeneration and metabolic balance. In severe cases, the presence of unintended forms of Vitamin B12 (Cyanocobalamin) may lead to altered metabolic response or unexpected adverse effects in patients with impaired renal or hepatic function.
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.

101. Recall Alert – Cream Kanadex-N (Batch # D7-22 & F7-27) – Substandard.

Salateen Philip Recall Alerts October 24, 2025October 24, 2025Recall

Recall Alert

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert No	No II/S/10-25-101
Action Date	24 October, 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.	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)	D7-22 & F7-27	M/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 (0.343 mg/g), which is an undeclared active pharmaceutical ingredient not stated on the product label.

Risk Statement:	The presence of an undeclared corticosteroid, coupled with sub-therapeutic potency of the declared active ingredient, may lead to unpredictable clinical outcomes, including reduced therapeutic efficacy, skin atrophy, hormonal disturbances, or systemic corticosteroid exposure, especially with prolonged use. Patients suffering from eczema, dermatitis, and other inflammatory skin conditions, as well as children and individuals using topical steroids on large surface areas, are the most likely to be affected. The use of this defective product undermines treatment safety and effectiveness and may result in adverse dermatological or systemic effects.
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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