Recall Alerts – Drug Regulatory Authority of Pakistan

132. Recall Alert – Veterinary Products – Substandard by DTLs Punjab.

Salateen Philip Recall Alerts January 14, 2026January 14, 2026Recall

Recall Alert

VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	N^oI/S/01-26-132
Action Date	14 January, 2026.
Target Audience	· National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers
Problem / Issue	Drug Testing Laboratories, Punjab informed that the sample of below mentioned Veterinary Drug products have been declared as *‘Substandard’*.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1	Injection, Actimec 10ml Ivermectin: 10 mg/ml (Reg # 034595)	AM-164	M/s Selmore Pharmaceuticals (Pvt) Ltd. 36 Km Off. Multan Road Lahore. (DML # 000507)	The sample is declared as “Sub-Standard” on the basis of Assay Test & Test for Related Substances.
2	MAC ROLD 1% 50ml Ivermectin: 10 mg/ml (Reg # 106810)	YI-146	M/s Haarlods Pharmaceuticals (Pvt) Ltd. Plot No.60-64/C, Small Industrial Estate, Bhimber, AJK. (DML # 000921)	The sample is declared as “Sub-Standard” on the basis of Assay Test, sterility test & Related Substances, while misbranded as per section 3(s)(vi) of the Drugs Act,1976. (Product does not contain Finished Drug Product Specifications)

Risk Statement:	The above veterinary ivermectin injectable products have been declared Sub-Standard due to failures in Assay, Related Substances, and Sterility tests, with one product also found misbranded for not meeting Finished Drug Product specifications. Use of such compromised injections may result in treatment failure, toxicity, infections, or adverse reactions in animals. The public most likely to be affected includes livestock farmers, dairy and meat producers, veterinarians, and animal handlers, as defective treatment can lead to animal illness, reduced productivity, economic losses, and potential downstream risks to milk and meat 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 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 and livestock owners are advised to immediately stop using the affected batch and isolate all remaining stock. Closely monitor treated animals for fever, swelling at the injection site, reduced appetite, or any sudden illness, and consult a veterinarian if such symptoms appear. Until animals are clinically stable, avoid selling or using milk or meat from visibly unwell animals. The affected product should be returned to the supplier or distributor according to recall instructions. Farmers are further advised to maintain proper records of batch numbers, treatment dates, and suppliers for traceability, and to ensure that only sterile, approved veterinary injections are used and stored under recommended conditions.

131. Recall Alert (Class-II) – DTLs Punjab Declared Substandard products.

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DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI.

DRAP Alert No	N^oII/S/01-26-131
Action Date	14 January, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratories of Provinces informed 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. Megadip Each tablel contains: Amlodipine as Besylate USP…. 5mg (Reg. # 071447)	25F278	M/s Mega Pharmaceuticals Ltd. 27 Km Raiwind Road Lahore (DML # 000537)	The samples have been declared Sub-standard with regards to Impurities test.
2.	Tablet Ascard 75 mg Each Enteric Coated Tablet contains: Aspirin 75 mg (Reg # 016600)	AR049L	M/s Atco Laboratories Limited, B-18 S.I.T.E Karachi. (DML # 000188)	The samples have been declared Sub-standard with regards to Test for Related substances (Impurity C: Salicylic Acid).
4.	Tablet CENEX 10 mg Cetirizine dihydrochloride 10mg (Reg # 032103)	422	M/s Dr. Raza Pharma. Road B-4 P.No 44-C Indus: Estate Jamrud Road Peshawar. (DML # 000387)	The sample is declared as “Sub-Standard” on the basis of test for Impurities i.e. Organic Impurities.
5.	Tablet Valron-P Each Sugar Coated Tablet contains: Diclofenac Sodium …. 50 mg (Reg # 030760)	T-03624	M/s Venus Pharma. 23 Km Multan Road Lahore. (DML # 000300)	The sample is declared as “Sub-Standard” on the basis of Disintegration and Dissolution Test.

Risk Statement:	The presence of excessive impurities, toxic contaminants, and performance failures in Megadip (amlodipine), Ascard (aspirin), Entagyl suspension (metronidazole), Cenex (cetirizine), and Valron-P (diclofenac) poses a significant risk to patient safety. Elevated levels of impurities, including salicylic acid, organic impurities, and ethylene glycol, may lead to toxicity, organ damage, allergic reactions, and gastrointestinal or neurological complications, while poor disintegration and dissolution can cause treatment failure or unpredictable dosing. The public most likely to be affected includes patients with heart disease, hypertension, infections, allergies, and chronic pain, particularly elderly patients, children, and those with kidney, liver, or cardiovascular disorders, where compromised medicine quality may result in serious and potentially life-threatening outcomes.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

130. Recall Alert – Drug Testing Laboratories, Punjab – Substandard products.

Salateen Philip Recall Alerts January 14, 2026January 14, 2026Recall

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DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI.

DRAP Alert No	N^oI/S/01-26-130
Action Date	14 January, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Central Drug Laboratory (CDL) Karachi informed 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.	Injection Neocobal Mecobalamin: 0.5 mg/ML (Reg. # 071447)	S-2901	M/s Pulse Pharmaceuticals (Pvt) Ltd. Mozay Badoke Raiwind Road (Sua Asil Road) Lahore. (DML # 000564)	The samples have been declared Sub-standard with regards to Assay and Adulterated as per Section 3 (a) (v) of The Drugs Act 1976.
2.	Injection Kamedex 1 ml Each ml contains: Dexamethasone Sodium Phosphate eq. to Dexamethasone phosphate …… 4 mg (Reg. # 074983)	DX-2485	M/s Amaan Pharma. 30-Km Sheikhupura Road Lahore (DML # 000808)	The sample has been declared Adulterated as per Section 3 (a) (v) of The Drugs Act 1976 (label claims Dexamethasone Sodium Phosphate equivalent to Dexamethasone Phosphate 4 mg/mL, laboratory analysis identified Dexamethasone base at a much lower level, rendering the composition false and misleading).
3.	Unisol NS Infusion 100ml Each 100 ml contains: Sodium Chloride …. 0.9g	5109040	M/s Unisa Pharmaceutical Industries Ltd. Main GT Road Adamzai Akora Khattak District Nowshera. (DML # 000740)	The sample has been declared Sub-standard on the basis of Bacterial Endotoxin test.
4.	Isobaj Injection 10ml Each ml contains: Isosorbide Dinitrate ……. 1mg (Reg # 100721)	IB-1125	M/s Bajwa Pharmaceuticals (Pvt) Ltd. 36-Km Lahore Gujranwala Road Khori District Sheikhupura. (DML # 000805)	The sample is declared as “Sub-Standard” on the basis of Bacterial Endotoxins Test (BET) & “Misbranded” as per section 3 (s) (iv) of the Drugs Act 1976. (sample does not comply with definition of BP monograph of “Isosorbide Dinitrate Injection” which states that “It is supplied as a ready-to-use solution”. While label mentions “Must be Diluted Prior to use on primary as well as secondary package of sample, that is contradictory with definition. Therefore, the sample is MISBRANDED).
5.	Infusion ZEESOL-H (RINGER LACTATE) Each 1000 ml contains: Calcium chloride 2H2O 0.27gms, Potassium Chloride 0.40 gms, Sodium Chloride 6.00gms, sodium lactate 3.20gms water for injection q.s (Reg # 019752)	2503281	M/s Shazeb Pharmaceutical Industries Ltd. Hazara Trunk Road Sarai Gadaee Dist.: Haripur. (DML # 000380)	The sample has been declared Sub-standard on the basis of Sterility test.
6.	Injection Neudex Dexamethasone Sodium Phosphate eq. to Dexamethasone Phosphate: 4mg/ml (Reg. # 32876)	DX079, DX080, DX064, DX060, DX042, DX063, DX072, DX067, DX068, DX070, DX065	M/s Neutro Pharma (Pvt) Ltd. 9.5-Km Sheikhupura Road Lahore. (DML # 000576)	The sample has been declared Adulterated as per Section 3 (a) (v) of The Drugs Act 1976 (label claims Dexamethasone Sodium Phosphate equivalent to Dexamethasone Phosphate 4 mg/mL, laboratory analysis identified Dexamethasone base at a much lower level, rendering the composition false and misleading).
7.	Entagyl Oral Suspension 400ml Each 5ml suspension contains: Benzoyl Metronidazole equivalent to 200mg of Metronidazole BP. (Reg # 087947)	272	M/s BJ Pharmaceuticals. Mandialai Stop Bhattianwala Road 18-Km Lahore Sheikhupura Road, Lahore. (DML# 000770)	The sample is Sub-Standard with regards to presence of impurity (Ethylene Glycol), above the permissible limit.

Risk Statement:	The identified quality defects in Neocobal Injection (mecobalamin), Kamedex Injection (dexamethasone), and Unisol NS Infusion present a serious risk to patient safety. Sub-standard potency and adulteration in injectable medicines may lead to treatment failure, incorrect dosing, and unpredictable clinical response, while contamination with bacterial endotoxins can cause fever, shock, and life-threatening reactions. The public most likely to be affected includes hospitalized patients, emergency and critically ill patients, children, pregnant women, and patients receiving steroid therapy, vitamin B12 injections, or intravenous fluids, where even small deviations in quality can result in severe and potentially fatal outcomes.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

129. Recall Alert(Class-I) – DIFAM Injection 3ml (Bosch Pharma) – Substandard

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DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI.

DRAP Alert No	N^oII/S/01-26-129
Action Date	14 January, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Central Drug Laboratory (CDL) Karachi informed 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.	DIFAM Injection 3ml Diclofenac Sodium (75mg/3ml) (Reg. # 014651-EX)	D260005, D260006	M/s Bosch Pharmaceuticals (Pvt) Ltd. (DML # 000707) Plot No. 209 Sector 23 Korangi Industrial Area Karachi.	The samples have been declared “Sub-Standard” on the basis of assay test.

Risk Statement:	Use of a sub-standard injectable diclofenac may lead to therapeutic failure or overdose-related toxicity, including inadequate pain and inflammation control, gastrointestinal bleeding, kidney injury, cardiovascular complications, and injection-site reactions. The groups most likely to be affected include patients receiving injections for acute pain, post-operative pain, arthritis, trauma, and emergency care, particularly elderly patients, individuals with kidney, heart or gastric disease, and hospitalized patients, where incorrect dosing may result in serious and potentially life-threatening outcomes.
Action Initiated	– The regulatory field force of DRAP and Provincial Drug Control departments has been directed to immediately conduct market surveys for detection and removal of these products from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and returned to the supplier/company. –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s).
Advice for Healthcare Professionals	DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP.
Advice for Consumers	-Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist.

128. Rapid Alert – Eventone-C Creams & LUFA Advanced Pain Relief Gel Containing Unauthorized Pharmaceutical Ingredient(s)

Salateen Philip Recall Alerts January 14, 2026January 14, 2026RapidAlert

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Unregistered and Falsified Cosmetic Cream Containing Unauthorized Pharmaceutical Ingredient(s)

DRAP Alert No	N^o I/S/01-26-128
Action Date	14 January , 2026
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 Laboratory analysis of Below mentioned Cream, marketed for skin fairness and treatment of skin darkness (cosmetic products) & a Gel marketed for pain relief, confirmed the presence of steroids (prescription-only corticosteroid). These products were being marketed as a cosmetic without declaring this pharmaceutical ingredient and without registration or authorization from the Drug Regulatory Authority of Pakistan (DRAP). The presence of a potent medicinal substance in a cosmetic product constitutes misrepresentation of identity, composition, and regulatory status, rendering the product an Unregistered and Falsified Drug Product under the Drugs Act, 1976.

The product identification d

S#	Product Name	Batch No.	Manufacturer	Remarks
1.	Eventone-C Cream	12706	M/s Pharma Health Pakistan Pvt. Ltd.	The sample has been declared “Un-registered/falsified” under the Drugs Act 1976 because Hydrocortisone has been identified as suspected by Federal Inspector of Drugs.
2	LUFA Advanced Pain Relief Gel	25C372	M/s ASR Global Traders	The sample has been declared “Un-registered/falsified” under the Drugs Act 1976 because Betamethasone has been identified as suspected by Federal Inspector of Drugs.

etails are as under: –

Risk Statement	The identification of hydrocortisone in Eventone-C Cream and betamethasone in LUFA Advanced Pain Relief Gel, both of which are prescription-only corticosteroids, in products being marketed without registration or authorization poses a serious public health risk. Use of these substances without medical supervision may result in skin thinning, steroid-induced acne, pigmentation disorders, delayed wound healing, suppression of local immunity, masking of infections, and worsening of underlying skin diseases. As these products are falsely presented as ordinary cosmetic and topical preparations, users are unknowingly exposed to potent pharmaceutical agents, increasing the risk of prolonged misuse, dependency, and irreversible skin damage, particularly in women, children, and long-term users.
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	Parents, caregivers, pharmacies, retailers, and online sellers are strongly advised to immediately check product names and batch numbers, stop use and sale of affected batches, and remove them from circulation. Consumers who have already used these products and observe any adverse symptoms in infants should seek immediate medical attention and report the case to the relevant health authority. This alert is issued in the interest of public health and infant safety, and dissemination through healthcare facilities, pharmacies, online platforms, and social media is strongly recommended.

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

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

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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.

126. Recall Alert (Class-I) – Injection Cara-Doba 5ml – Substandard

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

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUGS TESTING LABORATORY.

DRAP Alert No	N^oII/S/12-25-126
Action Date	30 December, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratory (DTL) Punjab informed 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.	Injection Cara-Doba 5ml Each 5ml Ampoule contains: Dobutamine HCl eq. to Dobutamine …. 250mg (Reg. # 054987)	24J009 & 25E004	M/s Caraway Pharmaceuticals. Plot No. 12 Street No. N-3 National Industrial Zone (RCCI) Rawat. (DML # 000629)	Batch # 24J009 The sample has been declared Sub-Standard, on the basis of Physical Description and Visible Particulates. Batch # 25E004 The Color has been changed to dark brown with crystallization. (Physical Description and Visible Particulates).

Risk Statement:	The administration of sub-standard injectable Dobutamine with visible particulates, discoloration, and crystallization poses a serious and immediate risk to patient safety, particularly for critically ill patients, cardiac patients, and those receiving intensive or emergency care, where Dobutamine is commonly used for acute cardiac support. Such quality defects may lead to embolism, phlebitis, systemic infections, reduced therapeutic efficacy, or unpredictable pharmacological response, potentially resulting in treatment failure, hemodynamic instability, or life-threatening complications, thereby warranting urgent regulatory intervention.
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.

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

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

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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

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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.

123. Recall Alert (Class-I) – Drug Products (Human) Substandard – Gligit Baltistan.

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

Recall Alert

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUGS TESTING LABORATORY.

DRAP Alert No	N^oII/S/12-25-123
Action Date	18 December, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drugs, Water & Food Testing Laboratory, Government of Gilgit Baltistan informed that the samples of below mentioned drug products have been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Remarks	Manufacturers
1.	Glitric Tablets Each prolonged release tablet contains: Glyceryl Trinitrate …………… 2.6 mg (Reg. # 119607)	25H261 & 25H262	Batch # 25H261 The sample has been declared “Substandard” on the basis of Assay & Dissolution Test. Batch # 25H262 The sample has been declared “Substandard” on the basis of Assay Test.	M/s Linta Pharmaceuticals. Plot # 03, Street S-5, National Industrial Zone, Rawat, Islamabad. (DML # 000810)
2.	Betahist Tablet Each Tablet contains: Betahistine DiHydrochloride … 16 mg (Reg. 091595)	25H249	The sample has been declared “Substandard” on the basis of Physical description. (Tablets found with softening, cracking, rough orange peel texture, easily break, and become powder when pressed with fingers).

Risk Statement:	The identified quality defects in Glyceryl Trinitrate prolonged-release tablets (Glitric 2.6 mg), including failure of assay and dissolution, and the severe physical instability observed in Betahistine tablets (Betahist 16 mg) may result in therapeutic failure and unpredictable dosing. Glyceryl Trinitrate is a critical cardiovascular medicine with a sensitive therapeutic window, and inadequate dosing may precipitate angina or serious ischemic events, particularlyinelderly patients and those with ischemic heart disease. Betahistine defects may lead to loss of efficacy in patients suffering from vertigo and balance disorders. The public most likely to be affected includes chronic cardiovascular and vestibular disorder patients, especially the elderly and comorbid populations.
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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