Recall Alerts – Drug Regulatory Authority of Pakistan

99. Recall Alert (Class-II)- Drug Products Declared Substandard.

Salateen Philip Recall Alerts October 22, 2025October 22, 2025Recall

Recall Alert

DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

DRAP Alert No	N^oII/S/10-25-99
Action Date	22 October, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Central Drugs Laboratory Karachi informed that the sample of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Zolint Suspension Each 5ml contains: FURAZOLIDONE…… 25 mg Metronidazole ………. 75 mg (Reg. # 016494)	25024	M/s Libra (Pvt) Ltd. 77 Industrial Estate Hayatabad Peshawar. (DML # 000369)	The sample has been declared ‘substandard’ on the basis of assay test of Furazolidone & Metronidazole.
2.	Cytobion Capsule Each capsule contains: Mecobalamin …… 500 mcg (Reg. # 062462)	H575	M/s Hoover Pharmaceuticals (Pvt) Ltd. Plot No.16 Zain Park Industrial Area Saggian By Pass Road Lahore. (DML # 000676)	The sample has been declared ‘substandard’ on the basis of description test wherein dark red crystals not found in sample while description is white capsule containing almost white fine powder with dark red crystals.

Risk Statement:	The use of these defective medicines may result in therapeutic failure and ineffective treatment, particularly affecting vulnerable groups such as children, elderly, diabetic, and anemic patients. Substandard quality of Zolint Suspension used for infectious diarrhea may lead to prolonged illness, dehydration, and microbial resistance, while the defective Cytobion Capsule used for neuropathies and Vitamin B12 deficiency may cause delayed neurological recovery and worsening of deficiency symptoms.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

98-Rapid Alert- Falsified / Unregistered Aphrodisiac Drug Product

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

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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.

97- RECALL ALERT – VETERINARY DRUG PRODUCT DECLARED MISBRANDED

Ahsan Hafiz Recall Alerts October 22, 2025October 22, 2025Recall

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VETERINARY DRUG PRODUCTS DECLARED MISBRANDED BY CENTRAL DRUGS LABORATORY, KARACHI.

DRAP Alert No	N^oIII/S/10-25-97
Action Date	22 October, 2025.
Target Audience	· National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers
Problem / Issue	Central Drugs Laboratory informed that the sample of below mentioned Veterinary product has been declared as *‘Misbranded*’.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1.	LISO-10 Powder Each gm Contains: – Lysozyme…….22% Vitamin E 50 SD…….0.5% (Reg. # 049566)	IO E004	M/s Mallard Pharmaceuticals (Pvt) Ltd. 23-KM Lahore Road Qadirpur, Multan. (DML # 000622)	The sample has been declared ‘Misbranded’ under Section 3(s)(i) of the Drugs Act, 1976. as the Batch Number, Date of Manufacturing, Date of Expiry, and Retail Pricewerenot printed or written in indelible ink in a conspicuous manner on both the outer carton and the innermost sachet.

Risk Statement:	Use of a misbranded batch undermines the ability of healthcare professionals and consumers to verify product authenticity and shelf-life, posing potential risks of administering expired or improperly stored formulations. Veterinary practitioners, distributors, and retailers are therefore advised to immediately stop distribution, sale, or use of the affected batch, segregate existing stock, and verify labeling conformity before dispensing or prescribing.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Veterinarian	This alert applies strictly to the specific batch listed above and does not apply to other batches of the same product. Veterinarians are therefore advised not to prescribe, administer, or stock these identified batch under any circumstances.
Advice for Farmers and Livestock Owners	Farmers and livestock owners are advised not to use LISO-10 Powder (Batch No. IO E004) that lacks proper labeling of batch number, manufacturing and expiry dates, or retail price, as such products cannot be verified for their authenticity, quality, or safety. Using an untraceable or expired product may reduce its effectiveness in protecting animal health and may even cause adverse reactions or treatment failure. Always ensure that veterinary medicines are purchased only from licensed veterinary stores or authorized distributors, and that each pack clearly displays the batch number, expiry date, and manufacturer details in permanent ink. If any pack is found without proper labeling, stop its use immediately, retain the sample, and report the issue to the nearest Drug Control Authority or veterinary officer for regulatory follow-up and replacement through authorized channels.

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.

95. Recall Alert – Veterinary Drug Product declared Substandard.

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

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VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	N^oI/S/10-25-95
Action Date	16th October, 2025.
Target Audience	· National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers
Problem / Issue	Drug Testing Laboratory from Province informed the Drug Regulatory Authority of Pakistan that the sample of below mentioned Veterinary product has been declared as ‘*Substandard*’.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1.	Oxytocin Injection 50ml Oxytocin Synthetic 10-IU/mL (Reg. # 019928)	V8-5	M/s ISIS Pharmaceutical & Chemical Works. 25/1-3 Sector 12-C North Karachi Industrial Area Karachi. (DML # 000126)	The sample is declared “sub-standard” on the basis of Sterility testing.

Risk Statement:	The use of Oxytocin Injection 50 ml (Batch No. V8-5) declared sub-standard on the basis of sterility testing, poses a significant risk to livestock health and animal productivity. As Oxytocin is commonly administered to dairy animals such as cows and buffaloes to induce milk let-down and facilitate parturition, use of a non-sterile injection may lead to severe local infections, fever, abscesses, or systemic septicemia in treated animals. This can result in economic losses to farmers and potential contamination of milk supply. All veterinarians, livestock owners, and distributors are therefore advised to immediately discontinue the use and sale of the affected batch and ensure that only quality-assured and sterile veterinary injectable preparations are procured from licensed sources.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Veterinarian	This alert applies strictly to the specific batches listed above and does not apply to other batches of the same products. Veterinarians are therefore advised not to prescribe, administer, or stock these identified batches under any circumstances. In case any of the above-mentioned batches have already been administered, treated animals should be closely monitored for possible signs of infection, treatment failure, or adverse reactions, and appropriate supportive care must be provided. Any suspected adverse events or quality-related problems linked to these batches should be reported immediately to DRAP’s Pharmacovigilance Centre and to the Provincial Livestock & Dairy Development Departments. Practitioners are further advised to ensure that only alternative registered and quality-assured batches are used in veterinary practice.
Advice for Farmers and Livestock Owners	Farmers, dairy owners, and animal keepers are strictly advised not to use these identified batches for their cattle or other livestock, as they may cause serious illness, infection, treatment failure, or even death in animals. If any of these batches have already been given, animals should be observed carefully for unusual symptoms such as fever, weakness, swelling at the injection site, or lack of recovery, and immediate veterinary assistance should be sought. Farmers are further advised to return such products to their supplier and use only safe, registered, and quality-assured veterinary medicines and vaccines to protect the health of their animals and avoid financial losses.

94. Recall Alert (Class-II) – Substandard Drug Products.

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

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	N^oII/S/10-25-94
Action Date	16th October, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Directorate of Drugs Control Punjab (DDCP) informed the Drug Regulatory Authority of Pakistan that the sample of below mentioned drug product has been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Kanabax Cream 15gm Each Gram contains: Dexamethasone ………… 1mg Neomycin sulphate ……… 3.5mg	KNX-272	M/s Baxter Pharmaceuticals. A-1/A Scheme No. 33 Phase-I S.I.T.E. Super Highway Karachi. (DML # 000700)	The sample is declared as “misbranded” with regards Labelling as per Section 3(s)(iv), ‘adulterated’ with regards to Section 3(a)(iv) of the Drugs Act,1976 & ‘substandard’ on the basis of Assay of Dexamethasone Phosphate.
2.	Zysic Tablet 10 mg Each film coated tablet contains: Cetirizine HCI (USP) … 10mg	727	M/s Jinnah Pharmaceuticals (Pvt) Ltd. 13-Km Lahore Road Multan. (DML # 000578)	‘Sub-Standard’ with regards to Impurities Test.

Risk Statement:	Use of Kanabax Cream (Batch No. KNX-272), declared misbranded, adulterated, and substandard, may lead to ineffective treatment, worsening of skin infections, or antimicrobial resistance, particularly in children and patients with chronic skin conditions. Similarly, Zysic Tablet 10 mg (Batch No. 727), found substandard due to impurities, may cause reduced efficacy or mild adverse effects in allergic or asthmatic individuals. Consumers are advised to avoid these batches and seek medical advice if already used.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

93. Recall Alert- Syrup Synadin 60ml (Batch # L24K110) -Substandard

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

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	N^oI/S/10-25-93
Action Date	16th October, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Directorate of Drugs Control Punjab (DDCP) informed the Drug Regulatory Authority of Pakistan that the sample of below mentioned drug product has been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Syrup Synadin 60ml Loratadine: 5mg/5ml	L24K110	M/s Synchro Pharmaceuticals. 77-Industrial Estate Kot Lakhpat Lahore. (DML # 000575)	The sample is declared as “sub-standard” on the basis of Physical Description Test, Assay Test & it contains the impurity Ethylene Glycol above the permissible limit.

Risk Statement:	Use of Synadin Syrup (Batch No. L24K110), declared substandard due to assay failure and presence of ethylene glycol impurity above permissible limits, poses a potential toxic risk, especially for children who are the primary users of antihistamine syrups. Consumers and healthcare providers are advised to immediately stop use of these batches and report any adverse events to DRAP or concerned authorities.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

RAPID ALERT – 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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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.

Recall Alert – Tablet Cloferd 50 mg (Batch # 6926) declared Substandard.

Ahsan Hafiz Recall Alerts October 15, 2025October 15, 2025Recall

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DRUG PRODUCT DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	N^oII/S/10-25-90
Action Date	15th October, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Provincial Health Department informed the Drug Regulatory Authority of Pakistan that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Tablet Cloferd 50 mg Each film coated tablet contains: Clomiphene Citrate .. 50mg (Reg. # 066676)	6926	M/s Medizan Laboratories (Pvt) Ltd. Plot No 313 Industrial Triangle Kahuta Road Islamabad. (DML # 000572)	The Sample is declared as “Sub-Standard” on the basis of Dissolution Test.

Risk Statement:	Clomiphene Citrate is indicated for the treatment of female infertility and ovulatory disorders. Use of a substandard product with inadequate dissolution may lead to reduced therapeutic efficacy, resulting in failure of ovulation induction, delayed conception, or treatment frustration in women of reproductive age undergoing fertility management. Timely identification and withdrawal of the affected batch are essential to prevent therapeutic failure and ensure patient safety.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

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