RapidAlert

RAPID ALERT – CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

Ahsan Hafiz Recall Alerts October 14, 2025October 14, 2025RapidAlert

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Rapid Alert

CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert No	No I/S/10-25-88
Action Date	14th October, 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 (DDCP) informed the Drug Regulatory Authority of Pakistan (DRAP) that the following purported drug product has been declared ‘spurious/falsified’ upon analysis and reportedly manufactured by entity not licensed or authorized by DRAP. The relevant laboratory findings and product details are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Manufacturer	Remarks
1.	CОХЕТО 120mL.   (SUSPECTED TO CONTAIN VITAMIN E, VITAMIN D AND COPPER SULPHATE)	005/APN,	ALI’s Pakistan Plot # 10, Street # 01, Al-Ghani Estate, Dullu Khurd Industrial Area, Ferozpur Road, Lahore.	‘Falsified’ Sample contains suspected ingredients i.e. Vitamin E  and does not contain Vitamin D & Copper Sulphate.
2.	Payodine 60ml   Each 100ml contains: Povidone-Iodine 10 gm equivalent to 1.0 gm available Iodine (1% w/v)	2709	S.A.R LAB Plot # 186, Korangi No. 04, Industrial Area Karachi	Sample declared as ‘Spurious’

Risk Statement	Purported drug product has been confirmed as falsified/spurious, as manufactured by entity neither licensed nor authorized by the Drug Regulatory Authority of Pakistan (DRAP). This product being illegally manufactured and marketed without regulatory oversight, rendering their quality, safety, and efficacy highly doubtful. Laboratory testing has revealed the absence of active pharmaceutical ingredient, indicating a complete lack of therapeutic value. The circulation and use of such unregulated product pose a serious risk to public health, including treatment failure, disease progression, and potential life-threatening consequences. The public is strongly advised to avoid the use of these unregistered drug products and report any suspicious or unauthorized medicines to DRAP through its official reporting channels.
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 – SPURIOUS DETECTED – Injection OXYZON 5% (Veterinary)

Ahsan Hafiz Recall Alerts October 13, 2025October 13, 2025RapidAlert

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Rapid Alert

SPURIOUS DETECTED – Injection OXYZON 5% (Veterinary)

DRAP Alert No	No I/S/10-25-87
Action Date	13th October, 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 sample of below mentioned Veterinary drug product has been declared as ‘Spurious’.

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Injection OXYZON 5% Each ml contains: Oxytetracycline Hcl ……. 50mg	AP/INJ-G/24-18	M/s. Amazon Pharmaceutical (Pvt) Ltd. Plot No. 10/A & 29/B, Small Industrial Estate, Bhimber, AJK (DML # 000881)	The Sample is declared as “SPURIOUS” as per section 3(zb)(i) of the Drugs Act 1976.

Risk Statement	The circulation of such a product in the market poses a serious public health hazard, particularly in rural and peri-urban livestock-dependent populations, where injectable antibiotics are widely used without adequate medical supervision. The unverified origin and uncertain quality of this spurious drug may lead to therapeutic failure, antimicrobial resistance, and potential toxicity in animals, indirectly affecting the food chain and community health. This situation raises grave concerns regarding the integrity of manufacturing and distribution practices, warranting urgent and coordinated regulatory intervention to protect public and veterinary health.
Action Initiated	The Regulatory Field Force has been directed to conduct surveillance activities to confiscate the abovementioned Spurious 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	Healthcare professionals, veterinarians, and distributors are advised to immediately discontinue the use, prescription, or sale of Injection OXYZON 5% (Batch No. AP/INJ-G/24-18) manufactured by M/s Amazon Pharmaceutical (Pvt) Ltd., Bhimber (DML #000881), as the product has been declared “Spurious” and its safety, efficacy, and quality cannot be assured. They should verify stock authenticity through label and batch details before administration or dispensing, report any adverse reactions or therapeutic failures to DRAP’s Med Vigilance Cell or the concerned Provincial Quality Control Office, and ensure the use of only registered, traceable products obtained through authorized supply chains in compliance with the Drugs Act, 1976 and DRAP Act, 2012.
Advice for Consumers	Animal owners are advised not to use Injection OXYZON 5% (Batch No. AP/INJ-G/24-18) manufactured by M/s Amazon Pharmaceutical (Pvt) Ltd., Bhimber (DML #000881), as it has been declared “Spurious” and may pose serious health risks. They should stop using any remaining stock immediately and report the product to the nearest Drug Inspector, Provincial Health Department, or DRAP Field Office. Always purchase medicines and veterinary products only from licensed pharmacies or authorized distributors, ensure the product has a valid registration number, and avoid medicines of unknown or unverifiable origin to protect health and safety.

RAPID ALERT – FALSIFIED / UNAUTHORIZED MANUFACTURER

Ahsan Hafiz Recall Alerts October 9, 2025October 14, 2025RapidAlert

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Rapid Alert

CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert No	No I/S/10-25-85
Action Date	26th 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	Manufacturer	Remarks
1.	Cipotic – D® Ear Drops   Each ml contains Ciprofloxacin (as HCl) … 1 mg Dexamethasone ………. 1 mg	F1538	Purported to be manufactured by M/s Barrett Hodgson Pakistan (Pvt) Ltd. F/423 SITE Karachi.	Sample declared “Spurious”with regards to Section 3(zb)(i ) & (ii) of the Drugs Act 1976 and ‘substandard’ on the basis of pH & sterility test.
2.	Tablet Danzen DS Each enteric coated tablet contains: Serratiopeptidase ………… 10 mg (20,000 serratiopeptidase units)	3945	Purported to be manufactured by M/s Helix Pharma (Pvt) Ltd. A/56 SITE Mangopir Karachi.	Sample declared “Spurious”with regards to Section 3(zb)(i ) & (ii) of the Drugs Act 1976.
3.	Tablet Tebisil 250 mg Each tablet contains: Terbinafine (as HCl) …. 250 mg	517	Purported to be manufactured by M/s Saffron Pharmaceuticals (Pvt) Ltd. 19-Km Sheikhupura Road Faisalabad	Sample declared “Spurious” with regards to Section 3(zb)(i ) & (ii) of the Drugs Act 1976.
4.	Capsule Cefspan 400 mg Each Capsule contains: Cefixime …………….400 mg	F0580	Purported to be manufactured by M/s Barrett Hodgson Pakistan (Pvt) Ltd.F/423 SITE Karachi.	Sample declared “Spurious” with regards to Section 3(zb)(i ) & (ii) of the Drugs Act 1976.
5.	Tablet Brexin 20 mg Each tablet contains: Piroxicam B-Cyclodextrine eq. to Piroxicam ………………. 20 mg	1206410	Purported to be manufactured by CHIESI FARMACEUTICI S.p.A.- 26/A, Via Palermo -PARMA-ITALY	Sample declared “Spurious” with regards to Section 3(zb)(i ) & (ii) of the Drugs Act 1976.

Risk Statement	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: UNREGISTERED & SUBSTANDARD — LEVITRA 20 mg TABLET (Batch BXNZ2488)

Ahsan Hafiz Recall Alerts October 8, 2025October 8, 2025RapidAlert

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Rapid Alert

CRACKDOWN AGAINST UNREGISTERED / FALSIFIED DRUG PRODUCTS

DRAP Alert No	No I/S/10-25-83
Action Date	08th October, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	Central Drugs Laboratory Karachi declared the following drug product as unregistered / falsified.

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Purported Manufacturer	Remarks
1.	Tablet Levitra 20mg   Each film coated tablet contains: Vardenafil (as HCl trihydrate) ……… 20mg	BXNZ2488	Purported to be manufactured by   M/s Bayer Pharma AG Germany	The sample has been declared ‘Unregistered / falsified’ .

Risk Statement	Since the product is not registered with DRAP, its quality, safety, and efficacy have not been evaluated or approved. The batch may contain incorrect or variable amounts of the active ingredient, unknown impurities, or be manufactured under non-compliant manufacturing conditions. Patients using this product may experience therapeutic failure, unpredictable adverse reactions, or serious health consequences due to lack of assured quality and authenticity. Misrepresentation of association with a well-known multinational company further increases the risk of false confidence, delayed appropriate treatment, and medication errors.
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 – FALSIFIED / SPURIOUS DRUG PRODUCT IN THE MARKET.

Ahsan Hafiz Recall Alerts September 26, 2025September 26, 2025RapidAlert

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CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS

DRAP Alert No	No I/S/09-25-81
Action Date	26th 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 (DDCP) 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.	Саpsule Eskem 40 MG   Each Capsule Contains: Enetric Coated Pellets of Esomeprazole Magnesium Tri-hydrate Equivalent to Esomeprazole ……. 40 Mg   (Reg.# 044310)	Not mentioned	Purported to be manufactured by   M/s High-Q Pharmaceuticals, Plot No. 224 & 225/1, Sector 23, Korangi Industrial Area, Karachi.	‘Substandard’ with respect to physical characteristics and “Misbranded” as defined under clause (i) of sub-section (s) of section 3 of The Drugs Act, 1976 and “Spurious” as defined under clause (i) & iii of subsection (zb) of section 3 of The Drugs Act, 1976. Details: Product label on outer carton does not bear batch number and immediate blister have illegible embossed marking. Moreover, as per the manufacturer’s method, the product is described as amethyst-colored capsules with the cap imprinted ‘High Q’ in black and the body imprinted Eskem 40, However, no such printing was observed on the actual capsules. Esomeprazole is not identified. Omeprazole is identified.

Risk Statement	Critical non-compliances include absence of batch number on the outer carton, illegible embossed markings on immediate blister packs, and deviation from the manufacturer’s approved description of capsule appearance (color and printing). Analytical testing confirmed that Esomeprazole was not identified and instead Omeprazole was detected, representing potential therapeutic failure and risk of inappropriate treatment. The presence of a spurious and misbranded product in the supply chain poses a serious threat to patient safety due to lack of assured identity, quality, and efficacy and requires immediate regulatory and field action to prevent its distribution and use.
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 FALSIFIED / SPURIOUS PRODUCTS

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

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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.

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

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

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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.

RAPID ALERT – CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS

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

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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

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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.

Falsified Vigamox® Ophthalmic Solution – Batch VHF02A (Not from Authorized Source)

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

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Falsified Vigamox® Ophthalmic Solution – Batch VHF02A (Not from Authorized Source)

DRAP Alert No	No I/S/09-25-66
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	Novartis Pharma (Pakistan) Ltd., Karachi informed DRAP that falsified Vigamox® Sterile Ophthalmic Solution bearing Batch # VHF02A is identified in the Pakistani market. The reported batch number is not imported, manufactured, or supplied by Novartis Pharma (Pakistan) Ltd., i.e. the genuine registration holder in Pakistan. The packaging falsely uses the Novartis name and branding, but it does not come from the authorized supply chain.

Risk Statement	In the case of Vigamox® (Batch No. VHF02A), such falsification may result in ineffective treatment of bacterial eye infections, potential worsening the infection, and risk of serious eye damage or vision loss. This alert applies only to Batch No. VHF02A and does not affect other batches of Vigamox® in the market supplied by the authorized registration holder. The falsified batch poses a particular risk to patients with eye infections, especially children, the elderly, and those with weakened immune systems, who may experience rapid deterioration if untreated or improperly treated.
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.

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