RapidAlert – Drug Regulatory Authority of Pakistan

Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS/ UNREGISTERED APHRODISIAC DRUG PRODUCTS

DRAP Alert No	N^o I/S/10-25-98
Action Date	22 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 (CDL), Karachi informed that the following drug product have been declared ‘spurious/falsified/unregistered’ upon analysis and reportedly manufactured by entities not licensed or authorized by DRAP. The relevant laboratory findings and product details are as under:

S#	Product Name	Batch No.	Manufacturer	Remarks
1.	JUMBO 150mg Capsules Each Capsule contains: Sildenafil Citrate ……. 150mg	JUC-05	M/s Combitic Global Caplet Pvt. Ltd. India	‘Unregistered (Falsified)’ drug product
2.	COBRA 150 Tablets Each tablet contains: Sildenafil Citrate ……. 150mg	CBT289	M/s Combitic Global Caplet Pvt. Ltd. India	‘Unregistered (Falsified)’ drug product
3.	BLACK COBRA 125 Tablets Each tablet contains: Sildenafil Citrate ……. 125mg	BOB96	M/s Combitic Global Caplet Pvt. Ltd. India	‘Unregistered (Falsified)’ drug product
4.	PENEGRA 100 Tablets Each tablet contains: Sildenafil Citrate ……. 100mg	G400016	M/s Zydus Lifesciences Limited, India.	‘Unregistered (Falsified)’ drug product
5.	BLACK COBRA 250 Tablets Each tablet contains: Sildenafil Citrate ……. 250mg	BOR-31	M/s Combitic Global, India.	‘Unregistered (Falsified)’ drug product
6.	Super CIALIS 5mg Tablets Each tablet contains: Sildenafil Citrate ……. 250mg	205-113	M/s HAB Pharmaceuticals & Research Limited, India.	‘Unregistered (Falsified)’ drug product
7.	KNIGHT RIDER DELAY SPRAY Contains Lidocaine	S-A0110	M/s Royal Herbal Ent. Co. Karachi.	‘Unregistered (Falsified)’ drug product
8.	TOKO-D3 Cream Contains Lidocaine	62051	M/s Mehran Homoeo Pharma, Mangora Swat.	‘Unregistered (Falsified)’ drug product
9.	UD Cream Contains Lidocaine	35924	M/s Mehran Homoeo Pharma, Mangora Swat.	‘Unregistered (Falsified)’ drug product

The product identification details are as under: –

Risk Statement	The above-mentioned products have been declared Unregistered and Falsified as they are not confirmed to have been manufactured, imported, or distributed through any supply chain duly authorized or licensed by the Drug Regulatory Authority of Pakistan (DRAP) or the respective Provincial Governments. The origin, composition, and quality of these products remain unverified; therefore, their safety and efficacy cannot be assured. The unregulated presence of such aphrodisiac preparations containing Sildenafil Citrate and Lidocaine poses significant public health risks, including potential cardiovascular complications, neurological adverse effects, and misuse in vulnerable populations. The continued sale or use of these products outside the legal distribution framework represents a serious threat to consumer safety and undermines regulatory control mechanisms intended to ensure the availability of genuine and quality-assured therapeutic goods.
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.

96. RAPID ALERT – FALSIFIED / SPURIOUS – CIALIS®

Ahsan Hafiz Recall Alerts October 20, 2025October 20, 2025RapidAlert

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Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS – CIALIS®

DRAP Alert No	N^o I/S/10-25-96
Action Date	20th 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 certified that Cialis® 20 mg Tablet bearing Batch # 24576 purported to be manufactured by M/s Eli Lilly and Company Limited, & Cialis® 20 mg Gold (Batch # MAL 19990546AG) purported to be manufactured by M/s Lilly ICOS, USA are “Falsified & spurious” identified in the Pakistani market. The reported Brands & batch numbers are not imported, manufactured, or supplied by the manufacturers mentioned on the label. The packaging falsely uses the name and branding, but it does not come from any authorized supply chain.

The product identification details are as under: –

Risk Statement	These falsified and spurious products pose a significant health risk to the public. Since the brands & batches have not been imported or supplied through any authorized or traceable source, its actual composition, safety, and efficacy remain unknown. Individuals who may have purchased this product from unauthorized medical stores, online platforms, or informal supply chains are at particular risk of exposure to unverified and potentially harmful ingredients. Use of such falsified medicine can lead to serious adverse health effects, therapeutic failure, or toxic reactions, especially among patients with cardiovascular or metabolic conditions.
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 – SPURIOUS / FALSIFIED (TABLET FEMARA 2.5 mg)

Ahsan Hafiz Recall Alerts October 16, 2025October 16, 2025RapidAlert

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Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUG PRODUCT

DRAP Alert No	N^o I/S/10-25-92
Action Date	16th 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	Novartis Pharma (Pakistan) Ltd., Karachi informed DRAP that falsified Femara® 2.5 mg Film Coated Tablet bearing Batch # TELX5 has been 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.

The product identification details are as under: –

Risk Statement	In the case of Femara® 2.5 mg Film Coated Tablet (Batch No. TELX5), such falsification may lead to ineffective treatment of hormone-dependent breast cancer, resulting in disease progression or relapse. This poses a serious risk to female cancer patients, particularly post-menopausal women, who depend on this medicine for long-term therapy. This alert applies only to Batch No. TELX5 and does not affect other genuine batches of Femara® available in the market from the authorized registration holder.
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 – SPURIOUS/FALSIFIED (TABLET MYTEKA 10 mg)

Ahsan Hafiz Recall Alerts October 16, 2025October 16, 2025RapidAlert

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Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS DRUG PRODUCT

DRAP Alert No	N^o I/S/10-25-91
Action Date	16th 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	Drug testing Laboratory from Punjab informed the Drug Regulatory Authority of Pakistan that the sample of below mentioned product has been declared *‘Spurious’* as its packaging falsely claims that it was manufactured by a licensed pharmaceutical company which has formally disowned the said product. The details of report are as under:

The product identification details are as under: –

Therapeutic Good Affected:-

S#	Product Name	Batch No.	Manufacturer	Remarks
1.	Tablet Myteka 10 mg Each film coated tablet contains: Montelukast Sodium eq. to Montelukast …. 10 mg	156428	Purported to be manufactured by: M/s HILTON PHARMA (PVT) LTD. PLOT NO. 13-14, SECTOR 15, KORANGI INDUSTRIAL AREA, KARACHI,	Sample is ‘Spurious’ as described under Section 3(zb)(i) & (ii) of Drugs Act 1976.

Risk Statement	Use of Myteka Tablet 10 mg (Batch No. 156428), falsely labeled as manufactured by M/s Hilton Pharma (Pvt.) Ltd., has been declared spurious and substandard, as testing revealed no active ingredient and the product is falsified under Section 3(zb)(i)&(ii) of the Drugs Act, 1976. Such falsified medicine poses a serious risk of treatment failure and adverse outcomes, particularly for asthmatic and allergic patients relying on genuine therapy. Consumers and healthcare professionals are advised to immediately stop using the said batch, verify authenticity, and report any suspected productsto DRAP or the concerned Provincial Drug Control authority.
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 October 14, 2025October 14, 2025RapidAlert

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Rapid Alert

CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert No	N^o 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	N^o 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	N^o 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	N^o 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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Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS PRODUCTS

DRAP Alert No	N^o 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	N^o 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.

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