Recall

RECALL ALERT – DRUG PRODUCTS (CLASS – I).

Ahsan Hafiz Recall Alerts September 25, 2025September 25, 2025Recall

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No I/S/09-25-79
Action Date	25 September, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Directorate of Drugs Control Punjab (DDCP) informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Injection. Lignozin-A 2mL Each ml ampoule contains: Lignocaine HCI B.P…….. 20mg Adrenaline B.P………….1:80,000	LG-001	M/s Trigon Pharmaceuticals (Pvt) Ltd. 8- Km Thokar Raiwind Road Lahore. (DML # 000342)	“Misbranded” as per Section 3(s)(iv) of The Drugs Act 1976 and “Sub-Standard” on the basis of Physical Test i.e Physical Description Test (Visible Particles), pH Test & Assay of Adrenaline.
2.	Satamin Injection Each ampoule contains: (Mecobalamin J.P) 500ug	MC24-030	M/s Saturn Pharmaceuticals (Pvt) Ltd. 23-Km, Thokar Raiwind Road Lahore. (DML # 000734).	‘Adulterated’ as per Section_3 (a) (v) of The Drugs Act 1976.

Risk Statement:	The defects identified in the sampled injections pose serious risks to patient safety and therapeutic effectiveness. Injection Lignozin-A 2 mL (Batch LG-001) manufactured by M/s Trigon Pharmaceuticals (Pvt.) Ltd. has been declared Misbranded under Section 3(s)(iv) of the Drugs Act, 1976, and Substandard on the basis of physical description (visible particles), pH, and assay of adrenaline, raising concerns of compromised sterility, safety, and efficacy. Similarly, Satamin Injection (Batch MC24-030) manufactured by M/s Saturn Pharmaceuticals (Pvt.) Ltd. has been declared Adulterated under Section 3(a)(v) of the Drugs Act, 1976, which represents a severe violation of product quality and purity standards. The circulation and use of these defective products may lead to therapeutic failure, unpredictable adverse reactions, and potential harm to patients, warranting urgent regulatory and recall action.
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.

RECALL ALERT – TABLET ASCARD-75 (Batch # AR046L)

Ahsan Hafiz Recall Alerts September 25, 2025September 25, 2025Recall

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert No	No II/S/09-25-78
Action Date	23 September, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Directorate of Drugs Control Punjab (DDCP) informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Tablet Ascard-75   Each enteric coated tablet contains: Acetylsalicylic Acid (Aspirin BP)……………75 mg	AR046L	M/s Atco Laboratories Limited, B-18 S.I.T.E Karachi. (DML # 000188)	‘Sub-Standard’ with regards to Related Substances Test (Impurity C: Salicylic Acid).

Risk Statement:	The Drug Testing Laboratory has declared the given sample as ‘substandard’ on basis of failure in the Related Substances Test, showing the presence of Impurity C (Salicylic Acid) beyond the permissible pharmacopeial limits. The presence of such impurity may lead to adverse effects including gastric irritation and related complications, particularly in sensitive patient populations. While not considered immediately life-threatening, this defect poses a significant quality concern that may cause temporary or medically reversible adverse health consequences.
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.

Recall Alert – Class II (Tablet Ascard-75) Batch # AR021L

Ahsan Hafiz Recall Alerts September 23, 2025September 25, 2025Recall

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PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert No	No II/S/09-25-77
Action Date	23 September, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Directorate of Drugs Control Punjab (DDCP) informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Tablet Ascard-75   Each enteric coated tablet contains: Acetylsalicylic Acid (Aspirin BP)……………75 mg	AR021L	M/s Atco Laboratories Limited, B-18 S.I.T.E Karachi. (DML # 000188)	‘Sub-Standard’ with regards to Related Substances Test (Impurity C: Salicylic Acid).

Risk Statement:	The Drug Testing Laboratory has declared the given sample as ‘substandard’ on basis of failure in the Related Substances Test, showing the presence of Impurity C (Salicylic Acid) beyond the permissible pharmacopeial limits. The presence of such impurity may lead to adverse effects including gastric irritation and related complications, particularly in sensitive patient populations. While not considered immediately life-threatening, this defect poses a significant quality concern that may cause temporary or medically reversible adverse health consequences.
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.

RECALL ALERT – Class I – Substandard drug Products

Ahsan Hafiz Recall Alerts September 23, 2025September 23, 2025Recall

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PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert No	No I/S/09-25-76
Action Date	23 September, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Directorate of Drugs Control Punjab (DDCP) informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Injection. Lignozin-A 2mL Each ml ampoule contains: Lignocaine HCI B.P…….. 20mg Adrenaline B.P………….1:80,000	LG-001	M/s Trigon Pharmaceuticals (Pvt) Ltd. 8- Km Thokar Raiwind Road Lahore. (DML # 000342)	The Sample is declared as “Misbranded” as per Section 3(s)(iv) of The Drugs Act 1976 and “Sub-Standard” on the basis of Physical Test i.e Physical Description Test (Visible Particles), pH Test & Assay of Adrenaline.
2.	Aqua-P Injection Sterile water for injection 5ml	P-679	M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551)	‘Sub-standard’ on the basis of “Visible particulate matter” as per USP.
3.	Neocobal Injection 0.5 mg Each ml contains: Mecobalamin.0.5 mg	S-2705	M/s Pulse Pharmaceuticals (Pvt) Ltd. Mozay Badoke Raiwind Road (Sua Asil Road) Lahore. (DML # 000564)	‘Substandard’ with regards to Assay and ‘Adulterated’ as per Section 3 (a) (v) of The Drugs Act 1976.
4.	Kanadex-N Cream   Each gram contains: 1 mg of dexamethasone-21 phosphate in the form of disodium salt U.S.P. 3500 i.u. of Neomycin in the form of Sulphate U.S.P.)	F7-27	M/s ISIS Pharmaceutical & Chemical Works. 25/1-3 Sector 12-C North Karachi Industrial Area Karachi. (DML # 000126)	‘Substandard’ with regards to Assay of Dexamethasone Phosphate and Adulterated as per Section 3 (a) (v) of The Drugs Act 1976.
5.	Remedy Injection 500 mcg   Each 1ml ampoule contains: 500mcg of Mecobalamin	R-2419	M/s Pak Risen Pharmaceuticals. Plot No. 3 Block B Phase-I-II Industrial Estate Hattar. (DML # 000573)	‘Adulterated’ as per Section 3 (a) (v) of The Drugs Act 1976.

Risk Statement:	The presence of visible particles, failed assays, incorrect active ingredient levels, and adulteration with undeclared or unsafe components renders these medicines unsafe, ineffective, and potentially harmful to patients. Their use may result in treatment failure, unpredictable adverse effects, and serious safety risks including allergic reactions, infections, or toxicity.
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.

RECALL ALERT – PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

Ahsan Hafiz Recall Alerts September 19, 2025September 19, 2025Recall

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PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert No	No I/S/09-25-75
Action Date	19th September, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratory Faisalabad has informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug product has been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Wisdom powder for injection (Ceftriaxone 500mg)	WSM-027	Trigon Pharmaceuticals (Pvt.) Ltd., Thokar-Raiwind road, Lahore.	Substandard on the basis of failure of sterility test.

Risk Statement:	Use of the affected batches of Ceftriaxone Injection may pose a significant risk to patient safety. As this product is administered parenterally, compromised quality (such as sterility failure) can result in serious adverse health consequences. Potential risks include treatment failure, severe infection, sepsis, or life-threatening hypersensitivity reactions. Vulnerable populations, including neonates, children, and immunocompromised patients, are at particular risk of harm. Therefore, continued distribution or use of the defective product may lead to serious, sometimes fatal, health outcomes.
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.

VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

Ahsan Hafiz Recall Alerts September 18, 2025September 18, 2025Recall

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VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No I/S/09-25-73
Action Date	18 September, 2025.
Target Audience	·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments. ·         Healthcare Professionals-Veterinarians ·         Farmers/consumers
Problem / Issue	Drug Testing Laboratories from Provinces informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned Veterinary products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1	Inj. Rasomycin-5 50ml Oxytetracycline HCl – 50 mg /ml	VM800	M/s Star Laboratories (Pvt) Ltd. 23 Km Multan Road Lahore. (DML # 000130)	The Drug Testing Laboratory, Bahawalpur has declared the product ‘misbranded’ under Section 3(s)(iv) of the Drugs Act, 1976, and ‘substandard’ due to failure in the Bacterial Endotoxin Test.
2.	Inj. Duralin -50 Oxytetracycline (as HCl) -50mg/ml	5807	M/s Mylabs (Pvt) Ltd. Khanka Sharif Tehsil and District Bahawalpur. (DML # 000747)	The Drug Testing Laboratory, Multan has declared the product ‘misbranded’ under Section 3(s)(iv) of the Drugs Act, 1976, and ‘substandard’ due to failure in the  Sterility Test.

Risk Statement:	These quality defects directly compromise animal safety, therapeutic effectiveness, and indirectly pose risks to public health through the livestock production chain. Therefore, the products are classified as high-risk veterinary medicines requiring immediate regulatory attention.
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, dairy owners, and animal keepers are strictly advised not to use these identified batches for their cattle or other livestock, as they may cause serious illness, infection, treatment failure, or even death in animals. If any of these batches have already been given, animals should be observed carefully for unusual symptoms such as fever, weakness, swelling at the injection site, or lack of recovery, and immediate veterinary assistance should be sought. Farmers are further advised to return such products to their supplier and use only safe, registered, and quality-assured veterinary medicines and vaccines to protect the health of their animals and avoid financial losses.

RECALL ALERT – DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

Ahsan Hafiz Recall Alerts September 18, 2025September 18, 2025Recall

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No I/S/09-25-72
Action Date	18th September, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Directorate of Drugs Control Punjab (DDCP) informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Satafenac Injection.     Each 3mL contains: Diclofenac Sodium (В.Р) 75mg	DS25-152	M/s Saturn Pharmaceuticals (Pvt) Ltd. 23-Km, Thokar Raiwind Road Lahore. (DML # 000734)	The Drug Testing Laboratory, Lahore has declared the product ‘substandard’ on the basis of ‘visible particulate matter’.
2.	Infusion METROIN 100ML Metronidazole 500mg/100ml	MT25-029 & MT25-083	M/s Saturn Pharmaceuticals (Pvt) Ltd. 23-Km, Thokar Raiwind Road Lahore. (DML # 000734)	The Drug Testing Laboratory, Bahawalpur has declared the Batch # MT25-029 of product as ‘substandard’ on the basis of ‘Bacterial Endotoxin test. & The Drug Testing Laboratory, Lahore has declared the Batch # MT25-083 of product as ‘substandard’ on the basis of ‘Particulate contamination: visible particles’ & ‘sterility test’
3.	Aqua-P Injection Sterile water for injection 5ml	P-678	M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551)	The Drug Testing Laboratory, Lahore has declared the product as ‘substandard’ on the basis of ‘visible particulate matter’ & ‘Bacterial endotoxin test’
4.	Injection Cara-Fer 5ml   Each ampoule (5ml) contains: iron sucrose complex eq. to elemental iron ………. 100mg (Reg # 052523)	24G001	M/s Caraway Pharmaceuticals. Plot No. 12 Street No. N-3 National Industrial Zone (RCCI) Rawat. (DML # 000629)	The Drug Testing Laboratory Rawalpindi has declared the product as “Substandard” with respect to pH test, Turbidity test and Alkalinity test performed.

Risk Statement:	The defects identified include presence of visible particulate matter, bacterial endotoxin contamination, sterility failure, and particulate contamination. Use of such defective injectable products may pose serious health risks, including infection, sepsis, and adverse clinical complications, particularly in vulnerable patient populations. Healthcare professionals, distributors, and patients are strongly advised to stop the use of the above-mentioned batches immediately and follow DRAP’s recall and reporting procedures.
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.

RECALL ALERT – -VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

Ahsan Hafiz Recall Alerts September 17, 2025September 17, 2025Recall

Recall Alert

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VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No I/S/09-25-71
Action Date	17 September, 2025.
Target Audience	·         National Regulatory Field Force of DRAP and Provincial Drug Control Departments. ·         Healthcare Professionals-Veterinarians ·         Farmers/consumers
Problem / Issue	Drug Testing Laboratories from Provinces informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned Veterinary products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1	INJECTION VARIAX 100ML   EACH ML CONTAINS: VITAMIN A 15.000 I , VITAMIN D3 1,000 IU, VITAMIN E 20MG, VITAMIN B1 10MG, VITAMIN B SODIUM PHOSPHATE 5MG, VITAMIN B6 3MG. NICOTINAMIDE 35MG, PANTOTHENOL 25MG, VITAMIN B12 50MCG	EI-1654	M/s. Eterna Pharma (Pvt) Ltd.   Plot No. 99, 100, 101 &198-C, Sector D1, Old Industrial Estate, Mirpur, AJK Pakistan. (DML # 000923)	‘Adulterated’ with respect to Assay test performed for Vìtamin B1 and is “Adulterated” as defined under clause (iv) of sub-section (a) of section 3 of The Drugs Act, 1976 as it contains Ascorbic Acid, Ambrosic Acid and Peiminine as ingredients other than the labelled ingredients.
2	Ivermex Injection 100 mL Each ml contains Ivermectin …. 10 mg	IV348	M/s Wimits Pharmaceuticals (Pvt) Ltd. Plot No. 129 Sundar Industrial Estate Lahore. (DML # 000789)	‘Substandard’ quality on the basis of the result of test for related substance, sterility & assay of Ivermectin.
3	PRIMOX injectable suspension 50mL Each ml contains amoxicillin (as trihydrate) …. 150 mg	PP9789	M/s Prix Pharmaceutical (Pvt) Ltd.   Plot No. 5 Pharmacity 30-Km Multan Road Lahore. (DML # 000587)	‘Substandard’ quality on the basis of the result of sterility test.
4	Injection Lumpyvac 50   After reconstitution, each 2ml dose contains: Attenuated Lumpy Skin Disease Virus (Neethling strain) ……. ≥103.5 TCID50     Diluent for Lumpy Skin Disease Vaccine for Cattle (For Veterinary Use) Potassium Chloride 0.2mg Potassium Phosphate monobasic 0.2 mg Sodium Chloride 0.8mg, Sodium Phosphate dibasic 1.14mg per 2 mL (Reg # 111128)	25/LSD/01	Importer: M/s Huzaifa International. Commercial Area, Aziz Bhatti Town, Dist. Sargodha. Manufacturer: Vetal animal Health Product S.A Organize Sanayi Bolgesi, Petrol Mah. 14. Cad. No. 01, Adiyamam, Turkey	‘Substandard’ on the basis of the result of sterility test.
5	Injection Oxytocin 50ml Oxytocin 10 IU/Ml Reg# 014564	V-06725	M/s Venus Pharma. 23-Km Multan Road. Lahore. (DML # 000300)	‘Substandard’ on the basis of the result of sterility test.
6	Injection Oxytovetz 50ml Oxytocin (USP) … 10 IU/mL Reg. # 111468	25129639	M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)	‘Substandard’ on the basis of the result of sterility test.

Risk Statement:	Use of the above-mentioned veterinary drug products poses serious risks to animal health and public safety: ·   Treatment failure and loss of therapeutic efficacy in livestock. ·   Microbial contamination leading to sepsis and animal deaths. ·   Ineffective vaccination against Lumpy Skin Disease, increasing risk of outbreaks. ·   Adverse economic impact on farmers due to animal health losses. Food safety risks through compromised milk and meat supply chains.
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, dairy owners, and animal keepers are strictly advised not to use these identified batches for their cattle or other livestock, as they may cause serious illness, infection, treatment failure, or even death in animals. If any of these batches have already been given, animals should be observed carefully for unusual symptoms such as fever, weakness, swelling at the injection site, or lack of recovery, and immediate veterinary assistance should be sought. Farmers are further advised to return such products to their supplier and use only safe, registered, and quality-assured veterinary medicines and vaccines to protect the health of their animals and avoid financial losses.

Recall Alert – DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

Ahsan Hafiz Recall Alerts September 17, 2025September 17, 2025Recall

Recall Alert

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No I/S/09-25-69
Action Date	15 September, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratories from Provinces informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1	SN DOL Suspension 60ml.   Each 5ml contains: Paracetamol ……… 120 mg	917	M/s SNB Pharma (Pvt) Ltd. Plot No. 142 Industrial Estate Hayatabad Peshawar. (DML # 000759)	‘Substandard’ on the basis of presence of impurity (Ethylene Glycol), above the permissible limit.
2	SALBOVENT Oral syrup 60ml   Each 5ml contains Salbutamol (as sulphate) .. 2mg	L25D52	M/s Synchro Pharmaceuticals. 77-Industrial Estate Kot Lakhpat Lahore. (DML # 000575)	‘Substandard’ on the basis of presence of impurity (Ethylene Glycol), above the permissible limit.
3	RESGYL Suspension 60 ml   Each 5ml contains Benzoyl Metronidazole equivalent to Metronidazole ………… 200 mg	4E566	M/s Rasco Pharma (Pvt) Ltd. 5.5 Km Raiwind Road Ali Razabad, Lahore. (DML # 000530)	‘Substandard’ on the basis of presence of impurity (Ethylene Glycol), above the permissible limit.
4	Tablet Daisy 10 mg   Each film coated tablet contains Cetirizine Dihydrochloride USP ………………………….10mg	258084 & 258085	M/s Mega Pharmaceuticals Ltd. 27 Km Raiwind Road Lahore (DML # 000537)	‘Substandard’ on the basis of Test for impurities (Organic impurities).
5	Colchis Capsules   Each Hard Gelatin Capsule contains: Thiocolchicoside ……….4 mg	15	M/s Akson Pharmaceuticals (Pvt) Ltd. Plot No. 9B-1 & 2 Sector D-1 Old Industrial Estate Mirpur Azad Kashmir. (DML # 000486)	‘Substandard’ on the basis of Assay and uniformity of weight.
6	AQUA-P Injection (Sterile Water for Injection 5mL)	P-676 P-677	M/s Ipram International. Plot # 26 SS-3 National Industrial Zone Rawat. (DML # 000551)	Drug Testing Laboratory, Lahore declared the sample as ‘substandard’ quality on the basis of the result of test for bacterial endotoxins.
7	Sterile Water for Injection 10ml   Each Glass Ampoule contains: WFI …………………. 10mL	084L24	M/s Brookes Pharma (Pvt) Ltd. Plot No. 58-59 Sector No. 15 Korangi Industrial Area Karachi. (DML # 000275)	‘Substandard’ on the basis of Bacterial Endotoxins Test.
8	Sterile Water for injection 5 ml   Each Glass Ampoule contains: WFI …………………. 5 ml	130	M/s Wilshire Laboratories (Pvt) Ltd. 124/1 Industrial Estate Kot Lakhpat Lahore. (DML # 000232)	‘Substandard’ on the basis of Bacterial Endotoxins Test.

Risk Statement:	The above drug products have been declared substandard / adulterated due to toxic impurities, undeclared ingredients, assay failures, sterility issues, and bacterial endotoxins. Their use may cause treatment failure, harmful side effects, or serious health risks including infections and toxicity. Children, elderly, hospitalized, and immunocompromised patients are at greater risk. The public and healthcare providers are advised to stop use and return the affected batches immediately.
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.

Recall Alert: Lipidem® / Lipoplus® Emulsion for Infusion (Product Stability Risk)

Ahsan Hafiz Recall Alerts September 17, 2025September 17, 2025Recall

Recall Alert

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Lipidem® / Lipoplus® Emulsion for Infusion (Zone IV Stability Risk for Pakistan)

DRAP Alert No	No I/S/09-25-65
Action Date	17 September, 2025.
Target Audience	·         Hospitals (Public & Private): especially those with ICU, surgical, oncology, and nutrition support units. ·         Parenteral Nutrition Centre / Clinical Nutrition Teams: where lipid emulsions are routinely administered. ·         Pharmacists: particularly hospital pharmacists and those in charge of sterile/IV admixtures. ·         Physicians: especially intensivists, anesthesiologists, gastroenterologists, and pediatricians using parenteral nutrition. ·         Provincial Health Authorities & Regulatory Bodies: to ensure monitoring and enforcement at the provincial level. ·         Importer & Distributors: of Lipidem® / Lipoplus® in Pakistan. ·         Nursing Staff: involved in IV infusion preparation and administration.
Problem / Issue	Stability studies conducted by the manufacturer and German regulatory authority identified droplet-like agglomerates (subvisual fat particles) in Lipidem® / Lipoplus® emulsions stored at 25°C beyond 12 months. These agglomerates, if infused without appropriate filtration, may lead to serious adverse events, including fat embolism in pulmonary capillaries. The details of the product is as under: –

Therapeutic Goods (s) Affected: –

S#	Reg. #	Name of Drug(s) & Composition	Packing	Shelf Life	Importer details
1.	099492	Lipoplus Emulsion for Intravenous Infusion Each 1000 ml contains: Medium chain triglycerides…. 100gm Soya oil …………………… 80gm Omega-3-acid triglycerides… ….20gm (As per Innovator’s Specification)*	250m1 Glass Bottle	02 years	M/s B.Braun Pakistan (Pvt) Ltd, The Forum, Suite 216 Khayaban-e-Jami, Clifton Block 9, Karachi.   Godown address: Ground Floor Plot No. C-153, S-6F, Mehran Town, Karachi.

Risk Statement:	In stability studies conducted in Germany, droplet-like agglomerates were detected in Lipidem® / Lipoplus® emulsions stored at 25 °C beyond 12 months. To mitigate this risk under those conditions, the German authority recommended the use of a 1.2 µm lipid infusion filter during administration. Since Pakistan falls under Zone IV climatic conditions (hot and humid), which differ significantly from Germany (25°C), the risk of earlier onset of agglomerate formation cannot be excluded. To date, no stability information or scientific justification for Zone IV conditions has been provided by the manufacturer or Marketing Authorization Holder (MAH). Considering these factors and the higher temperature and humidity in Pakistan, the matter is classified as a Class I recall risk, as the defect may reasonably be expected to cause serious adverse health consequences if not managed appropriately.
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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