Month: September 2025

RECALL ALERT – PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

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

Recall Alert

Download

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.

RAPID ALERT – CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS

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

Download

Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS

DRAP Alert No	No I/S/09-25-74
Action Date	19th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Provincial Drug Testing Laboratories have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared ‘Spurious’. The details of reports are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Purported Manufacturer	Remarks
1.	Efaston tablet (Dydrogesterone 10mg)	41160	Purported to be manufactured by Lahore Chemical & Pharmaceutical Works (Pvt.) Ltd., Lahore.	Spurious (Does not contain active ingredient)
2.	Paracare 60ml suspension (Paracetamol 120mg/5ml)	PE-042	Purported to be manufactured by Wellcare Pharmaceuticals, Sargodha.	Spurious (Does not contain active ingredient)

Risk Statement	All the above mentioned purported drug products are confirmed as falsified/spurious, as the laboratory testing has revealed that the product contains no active pharmaceutical ingredient, resulting in complete lack of therapeutic effect. Such falsification poses a serious risk to public health, potentially leading to treatment failure, disease progression, and even life-threatening outcomes, particularly for patients relying on these medications for critical care. The public is strongly advised not to use these purported drug products and to report any suspicious or unverified medicines to DRAP immediately.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link.
Advice for Consumers	Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

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

Recall Alert

Download

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

Recall Alert

Download

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.

Minutes of 350th Meeting of the Registration Board

Abdul Qadir Registration Board September 18, 2025September 18, 2025

Minutes-of-350th-Meeting-of-Registration-BoardDownload

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

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

Recall Alert

Download

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.

SPURIOUS / FALSIFIED MEDICINE DETECTED – DAIZELIVE INJECTION 2ML (DIAZEPAM 10MG/2ML, CLAIMED)

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

Download

Rapid Alert

SPURIOUS / FALSIFIED MEDICINE DETECTED – DAIZELIVE INJECTION 2ML (DIAZEPAM 10MG/2ML, CLAIMED)

DRAP Alert No	No I/S/09-25-70
Action Date	17th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Directorate of Drugs Control Punjab informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared as ‘Spurious’.

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Injection Daizelive 2ml   Each 2ml ampoule contains: Diazepam …… 10 mg	DZ44	M/s Liven Pharmaceuticals (Pvt) Ltd. Sray Road, 49 KM, Multan Road, Phool Nagar, District Kasur (DML # 000881)	Drug Testing Laboratory, Rawalpindi has declared the sample as ‘spurious’ since it does not contain the claimed active ingredient (Diazepam) and instead contains an undeclared ingredient (Chlorpheniramine Maleate 45.283 mg/2ml).

Risk Statement	Laboratory testing has confirmed that the product labeled as Daizelive Injection 2ml (Diazepam 10mg/2ml) is spurious/falsified, as it does not contain Diazepam, instead contains Chlorpheniramine Maleate (45.283mg/2ml). Use of this falsified product poses a serious and life-threatening risk, particularly for patients requiring Diazepam for seizures, severe anxiety, or emergency care, as they will not receive the intended treatment. Healthcare professionals and the public are strongly advised to immediately discontinue use of this product, ensure recall compliance, and report any suspected adverse outcomes or suspicious stock to DRAP.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link.
Advice for Consumers	Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

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

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

Recall Alert

Download

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.

RAPID ALERT – CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS

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

Download

Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS

DRAP Alert No	No I/S/09-25-68
Action Date	17th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Drug testing Laboratories from Provinces have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared ‘Spurious’ as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. The details of reports are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Purported Manufacturer	Remarks
1.	Azomax 500mg (Azithromycin 500mg)	C1699	Purported to be manufactured by AGP Limited Karachi	Spurious (Does not contain active ingredient)
2.	Klaricid 500mg tablet (Clarithromycin 500mg)	722269XV	Purported to be manufactured by Abbott Laboratories Karachi	Spurious (Does not contain active ingredient)

Risk Statement	All the above mentioned purported drug products are confirmed as falsified/spurious, as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. Laboratory testing has revealed that the product contains no active pharmaceutical ingredient, resulting in complete lack of therapeutic effect. Such falsification poses a serious risk to public health, potentially leading to treatment failure, disease progression, and even life-threatening outcomes, particularly for patients relying on these medications for critical care. The public is strongly advised not to use these purported drug products and to report any suspicious or unverified medicines to DRAP immediately.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link.
Advice for Consumers	Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

RAPID ALERT – CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

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

Download

Rapid Alert

CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert No	No I/S/09-25-67
Action Date	17th September, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Drug testing Laboratories from Provinces have informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been declared ‘Spurious’ as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. The details of reports are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Purported Manufacturer	Remarks
	Dytron Tabelt 10mg (Dydrogesterone 10mg)	D1T	Purported to be manufactured by an unlicensed /illegal entity claimed to be Pax Pharmaceuticals Karachi	Spurious (Does not contain active ingredient)
	Levontis 375mg (Amoxicillin trihydrate: 250, Clavulanic Acid: 125mg)	LF2	-do-	Spurious (Does not contain active ingredient)
	Levontis 625mg (Amoxicillin trihydrate: 500, Clavulanic Acid: 125mg)	LF2	-do-	Spurious (Does not contain active ingredient)
	Levontis 625mg (Amoxicillin trihydrate: 875, Clavulanic Acid: 125mg)	LF4	-do-	Spurious (Does not contain active ingredient)
	Sulfira suspension (Sucralfate 1g/5ml)	SL6	-do-	Spurious (Does not contain active ingredient)
	Furin 50mcg aerosol spray (Mometasone Furoate 50mcg)	NF4	-do-	Spurious (Does not contain active ingredient)
	Droxel capsule 500mg (Cefadroxil Monohydrate 500mg))	RC5	-do-	Spurious (Does not contain active ingredient)
	Bromiz tablet (Bromazepam 3mg)	0007	Purported to be manufactured by an unlicensed /illegal entity claimed to be Miraz Pharma Kasur (Fictitious firm)	Spurious (Does not contain active ingredient)

Risk Statement	All the above mentioned purported drug products are confirmed as falsified/spurious, as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company whereas it was not. Laboratory testing has revealed that the product contains no active pharmaceutical ingredient, resulting in complete lack of therapeutic effect. Such falsification poses a serious risk to public health, potentially leading to treatment failure, disease progression, and even life-threatening outcomes, particularly for patients relying on these medications for critical care. The public is strongly advised not to use these purported drug products and to report any suspicious or unverified medicines to DRAP immediately.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Un-Registered/falsified product. All Pharmacists, chemists, and other healthcare professionals working at distributions, pharmacies, healthcare facilities, and other aspects of the supply chain system should immediately check the stock, and information related to the suppliers of such products should be provided to the Regulatory field force (DRAP, Provincial Drug Control Departments) to ensure the removal of these product from the circulation.
Advice for Healthcare Professionals	DRAP requests healthcare professionals to have increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by above mentioned product. Any adverse events or quality problems experienced with the use of these products should be reported to National or Provincial pharmacovigilance centers using Adverse Event Reporting Form or online through this link.  Further information on reporting problems to DRAP is available on this link.
Advice for Consumers	Consumers should not use these products and should contact their physician or healthcare provider(s) if they have experienced any problem related to taking or using the above mentioned products and should report the incident to the Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. All therapeutic goods must be obtained from licensed pharmacies and other authorized/licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt.

• ← Previous