RapidAlert – Drug Regulatory Authority of Pakistan

127. Rapid Alert – Falsified Duphalac Syrup (Batch # 251986127 )

Salateen Philip Recall Alerts December 30, 2025December 30, 2025RapidAlert

Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS/ UNREGISTERED DUPHALAC SYRUP 100 ML

DRAP Alert No	N^o I/S/12-25-127
Action Date	30 December, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	The Drug Testing Laboratory (DTL), Punjab has informed the Drug Regulatory Authority of Pakistan that a sample of the below-mentioned drug product has been declared spurious upon analysis. The contract manufacturer, M/s Highnoon Laboratories Ltd., 17.5 Km Multan Road, Lahore (DML No. 000155), for the genuine registration/marketing authorization holder, M/s Abbott Laboratories (Pakistan) Ltd., Karachi, of Duphalac Syrup, has confirmed that the impugned batch was not manufactured by them and is therefore spurious. The product is purported to be manufactured by M/s Abbott Laboratories Co., Canada, and has been declared “Unregistered (Falsified)”.

The product identification details are as under: –

S#	Product Name	Batch No.	Manufacturer	Remarks
1.	Syrup Duphalac 100ml Each 100 ml contains: Lactulose ……. 66.7 g	251986	Purported to be manufactured by M/s Abbott Laboratories Co. Canada.	The sample has been declared “Spurious” as per Section 3(zb)(i) & (ii) of the Drugs Act 1976.

Risk Statement	The circulation of a spurious and unregistered Duphalac Syrup (Lactulose) poses a significant risk to public health, particularly to pediatric patients, elderly individuals, and patients with chronic constipation or hepatic disorders, who are the primary users of this product. As the impugned batch was not manufactured by the authorized contract manufacturer and lacks regulatory oversight, there is a heightened risk of incorrect composition, contamination, reduced or excessive strength, and therapeutic failure, which may lead to worsening of disease, electrolyte imbalance, dehydration, or other serious adverse health outcomes.
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.

125. Rapid Alert – Crackdown Against Falsified / Spurious/ Unregistered Aphrodisiac Drug Products.

Salateen Philip Recall Alerts December 30, 2025December 30, 2025RapidAlert

Rapid Alert

Crackdown Against Falsified / Spurious/ Unregistered Aphrodisiac Drug Products

DRAP Alert No	N^o I/S/12-25-125
Action Date	30 December, 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:

The product identification d

S#	Product Name	Batch No.	Manufacturer	Remarks
1.	KNIGHT RIDER TABLET Contains Sildenafil Citrate	NIL	Made in UK	‘Unregistered (Falsified)’ drug product
2.	Dapox 60mg Tablet Contains Dapoxetine HCl	8288	M/s Cheap USA Pharmacy	‘Unregistered (Falsified)’ drug product

etails 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 Dapoxetine HCl 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.

124. Rapid Alert – Crackdown Against Unlicensed / Unauthorized Manufacturers.

Salateen Philip Recall Alerts December 30, 2025December 30, 2025RapidAlert

Rapid Alert

CRACKDOWN AGAINST UNLICENSED / UNAUTHORIZED MANUFACTURERS

DRAP Alert No	N^o I/S/12-25-124
Action Date	30 December, 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 informed that the following purported products have been declared “unregistered” and reportedly manufactured by entities not licensed or authorized by DRAP. The relevant laboratory findings and product details are as under:

The product identification details are as under: –

S#	Product Name	Batch No.	Manufacturer (unlicensed)	Remarks
1.	Tablet Taskeen-e-Dard	091	M/s LEO HEALTH CARE & RESEARCH LABORATORIES KARACHI.	The sample has been declared “Unregistered / Falsified” as it contains Diclofenac Sodium, an active pharmaceutical ingredient, while the manufacturing facility is not registered with DRAP.
2.	Tablet Pain Nil	01	M/S HAKEEM PURANA DAWAKHANA KARACHI	The sample has been declared “Unregistered / Falsified” as it contains Diclofenac Sodium, an active pharmaceutical ingredient, while the manufacturing facility is not registered with DRAP.

Risk Statement	The above-mentioned purported products have been confirmed as falsified, as they are manufactured by entities that are neither licensed nor authorized by the Drug Regulatory Authority of Pakistan (DRAP). These products are being illegally manufactured and marketed without regulatory oversight, rendering their quality, safety, and efficacy highly doubtful. The circulation and use of such unregulated products 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 products and report any suspicious or unauthorized medicines to DRAP through its official reporting channels. The presence of Diclofenac Sodium in unregistered and falsified tablet products manufactured by unlicensed facilities poses a serious public health risk, particularly to low-income patients, elderly individuals, and persons with chronic pain conditions who may use such products without medical supervision. As Diclofenac is associated with gastrointestinal bleeding, renal impairment, and cardiovascular risks, the absence of regulatory oversight, quality control, and proper labeling significantly increases the likelihood of overdose, adverse drug reactions, and treatment failure, thereby endangering public safety.
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.

122. Rapid Alert – Falsified / Spurious / Unregistered Tramadol Tablets.

Salateen Philip Recall Alerts December 18, 2025December 18, 2025RapidAlert

Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS/ UNREGISTERED TRAMADOL TABLETS

DRAP Alert No	N^o I/S/12-25-122
Action Date	18 December, 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 samples of following drug products sent by National Task Force (NTF), have been declared ‘spurious/falsified/unregistered’ as under:

The product identification details are as under: –

S#	Product Name	Batch No.	Manufacturer	Remarks
1.	Tablet TAMOL-X 225 mg Each tablet contains: Tramadol HCl …. 225 mg	TM004	M/s Ciba Pharmaceuticals (Pvt) Ltd. A-371 Nooriabad Main Super Highway Karachi (DML # 000825)	‘Unregistered (Falsified)’ Tablet Tamol X 225 mg is not registered with DRAP.
2.	Tramaking 250 mg Tablets Each tablet contains: Tramadol HCl …. 250 mg	TRD379	M/s Ciba Pharmaceuticals (Pvt) Ltd. A-371 Nooriabad Main Super Highway Karachi (DML # 000825)	‘Unregistered (Falsified)’ Tablet Tramaking 250mg is not registered with DRAP.
3.	Namadol – 225 mg Tablets Each tablet contains: Tramadol HCl … 225 mg	TRD2025	M/s Ciba Pharmaceuticals (Pvt) Ltd. A-371 Nooriabad Main Super Highway Karachi (DML # 000825)	‘Spurious & Falsified (unregistered)’ Tablet Namadol 225mg is not registered with DRAP & does not contain the Active Pharmaceutical Ingredient (Tramadol HCl) as claimed on the label claim.

Risk Statement	The above-mentioned products, namely Tablet TAMOL-X 225 mg, Tramaking 250 mg Tablets, and Namadol 225 mg Tablets, have been identified as unregistered, spurious, and falsified therapeutic goods and are therefore not evaluated or approved by DRAP for safety, quality, or efficacy. Laboratory findings indicate that Namadol 225 mg Tablets do not contain the declared Active Pharmaceutical Ingredient (Tramadol HCl), while the remaining products are unregistered and illegally manufactured/marketed, posing a serious public-health risk. Consumption of such products may result in therapeutic failure, uncontrolled pain, withdrawal symptoms, unexpected toxicity, overdose, respiratory depression, or other serious adverse drug reactions, particularly due to uncertain composition, strength, and quality. The population most likely to be affected includes patients suffering from moderate to severe pain, individuals with chronic pain conditions, post-operative patients, and persons misusing or dependent on opioid analgesics, as well as elderly patients and those with comorbidities (hepatic, renal, or respiratory disorders). Healthcare professionals, pharmacies, and distributors handling these products are also at risk of legal and regulatory consequences. Immediate removal of the products from the supply chain is essential to prevent potential harm to public health.
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.

121. Rapid Alert- Falsified SIMULECT (Basiliximab) for injection identified in the WHO African and European Regions.

Salateen Philip Recall Alerts December 10, 2025December 10, 2025RapidAlert

Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS/ UNREGISTERED APHRODISIAC DRUG PRODUCTS

DRAP Alert No	N^o I/S/12-25-121
Action Date	10 December, 2025
Target Audience	1. Regulatory Field Force of DRAP and Provincial Drug Control departments. 2. Healthcare Professionals 3. Pharmacies and medical stores
Problem Statement	This WHO Medical Product Alert refers to falsified SIMULECT 20mg (basiliximab) for injection – batch number SFYD2. The falsified product has been detected in Rwanda, Bulgaria, and Türkiye, and was reported to WHO in December 2024 and November 2025. In Pakistan, SIMULECT 20 mg (Reg. # 025218) is supplied as a powder vial with or without a water for injection (solvent) ampoule for reconstitution, by Novartis Pharma (Pakistan) Limited (Importer), and is administered either as an intravenous infusion or as an injection, usually in a hospital setting. The genuine manufacturer also identified several visual discrepancies on the packaging & Batch number. The falsified product shows batch number SFYD2, which is not a valid batch number for SIMULECT. A sample of the falsified product was forensically tested by the genuine manufacturer and found to contain no active pharmaceutical ingredients; instead, it contained ascorbic acid. Any SIMULECT product with batch number SFYD2 should be considered falsified. The falsified product label displays the National Drug Code NDC 0078-0331-84. While the National Drug Code (NDC) is a unique identifier for medicines marketed in the United States of America, the label contains other discrepancies compared to genuine SIMULECT packaging. · The genuine product lists the ingredient dose in milligrams using “mg,” while the falsified product uses “MG”. · The genuine product lists the country of manufacture as “Product of France” while the falsified product lists the country of manufacture as “Product of Switzerland or France”.

Risk Statement	TThis falsified product should be considered unsafe, and its use may pose severe and potentially life-threatening risks to patients, including: • Therapeutic failure leading to organ rejection. • Inadequate or excessive immune suppression, increasing vulnerability to opportunistic infections. • Life-threatening allergic or toxic reactions from unknown or harmful ingredients. • Risk of infection from unsterile injections. It is important to detect and remove any falsified SIMULECT from circulation to prevent harm to patients.
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.

102. Rapid Alert – Falsified / Spurious Veterinary Drug Products

Salateen Philip Recall Alerts October 27, 2025October 27, 2025RapidAlert

Rapid Alert

CRACKDOWN AGAINST FALSIFIED / SPURIOUS VETERINARY DRUG PRODUCTS

DRAP Alert No	N^o I/S/10-25-102
Action Date	27 October, 2025
Target Audience	– Regulatory Field Force of DRAP and Provincial Drug Control departments. – Healthcare Professionals / Veterinarians – Consumers (Livestock owners, farmers, and animal caretakers)
Problem Statement	Drug Testing Laboratories from provinces, informed that the following Veterinary Drug products have been declared ‘spurious/falsified’ as its packaging falsely claims that it was manufactured by a licensed Veterinary pharmaceutical company which has formally disowned the said product. The details of report are as under

The product identification details are as under: –

S#	Product Name	Batch No.	Manufacturer	Remarks
1.	Powder for inj. Penbiotic Procaine Penicillin ……. 1500,000 I.U, Benzyl Penicillin ……… 500,000 I.U, Streptomycin Sulphate … 5.0gm.	V01745	Purported to be manufactured by M/s Nawan Laboratories (Pvt.) Ltd. 136, Sector 15, Korangi, Karachi.	The sample is declared as “Spurious” as per section 3(zb) (i) & (ii) of The Drugs Act 1976.
2.	Powder for inj. PENIVET-5 Benzyl Penicillin ……… 500000IU Procaine Penicillin ……. 1500000IU Streptomycin Sulphate … 5g	VK-1496	Purported to be manufactured by Star Laboratories (Pvt.) Ltd. (Animal Health Care Division) 23-Km, Multan Road, Lahore.	The sample is declared as “Spurious” as per section 3(zb) (i) & (ii) of The Drugs Act 1976.
3.	Procaine Penicillin Inj.4.000,000 IU (Powder for injection) Each vial contains: Procaine Penicillín …. 3,000,000 I.U. Benzyl Penicillin …… 1,000,000 I.U.	190315	Purported to be manufactured by Shanghai Pharmaceutical Industry Corp. China. Shanghai P.R. China. M/S Shaheen Agency (Importer)* disowned the given sample*	The sample is declared as “Spurious” as per section 3(zb) (i) & (ii) of The Drugs Act 1976.

Risk Statement	The use of these spurious veterinary drug products poses a significant risk to animal health and indirectly to public health. Since the reported products were falsely labelled with the names of licensed manufacturers who have disowned them, their origin, composition, and sterility remain unknown. Administration of such falsified antibiotics in livestock may lead to therapeutic failure, severe infections, or toxicity in animals, and contributes to the emergence of antimicrobial resistance (AMR) due to exposure to sub-therapeutic or adulterated formulations.
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	Veterinary practitioners, pharmacists, and other healthcare professionals are strongly advised not to prescribe, dispense, or administer the above-mentioned batches of Veterinary drug products declared as spurious/falsified. Since these products do not originate from licensed manufacturers and their quality, safety, and efficacy cannot be assured, their use may result in ineffective therapy, treatment failure, or serious adverse reactions in animals. 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	Livestock owners, farmers, and animal caretakers are strongly advised not to use or purchase the veterinary products mentioned above, as they have been declared spurious/falsified. These products falsely claim to be manufactured by licensed pharmaceutical companies, but their origin, quality, and safety are unknown, which means they may cause treatment failure, serious illness, or even death in animals.

98-Rapid Alert- Falsified / Unregistered Aphrodisiac Drug Product

Salateen Philip Product Recalls, Recall Alerts, Safety Info October 22, 2025October 22, 2025RapidAlert

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

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

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

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.

← Previous