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134. Recall Alert (Class-II) – CDL declared substandard – Henafim Paediatric Suspension

Salateen Philip Recall Alerts January 21, 2026January 21, 2026Recall

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DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUG LABORATORY KARACHI.

DRAP Alert No	No II/S/01-26-134
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	Manufacturers	Remarks
1.	Henafim Paediatric Suspension Each 5ml contains: Paracetamol …. 120mg Chlorphineramine Maleate …. 1mg (Reg. # 078545)	558	M/s Wisdom Pharmaceutical Industry. (DML # 000780) 78-A Industrial Estate Hayatabad Peshawar.	The samples have been declared  “Sub-Standard” on the basis  of assay test of Paracetamol (71%) & Chlorpheniramine Maleate (81%).

Risk Statement:	The use of Henafim Paediatric Suspension, Batch No. 558, poses a potential risk to public health, particularly affecting infants and children, who are the primary users of this product for the management of fever, pain, and allergic symptoms. The product has been declared sub-standard due to low assay results of Paracetamol (71%) and Chlorpheniramine Maleate (81%), which may lead to inadequate therapeutic response, resulting in poor fever control, persistent discomfort, and unresolved allergic symptoms. This may prompt caregivers to administer repeated or higher doses, increasing the risk of medication misuse. Although not adulterated, the reduced potency of this paediatric formulation may compromise effective treatment in a vulnerable population, warranting regulatory attention and appropriate risk management.
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.

133. Recall Alert (Class-I) – Tablet BP-NORM (Substandard & Adulterated)

Salateen Philip Recall Alerts January 21, 2026January 21, 2026Recall

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DRUG PRODUCT DECLARED SUBSTANDARD & ADULTERATED BY DRUG TESTING LABORATORIES, PUNJAB.

DRAP Alert No	No I/S/01-26-133
Action Date	21 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 Punjab Province informed that the samples of below mentioned drug products have been declared as ‘Substandard & Adulterated’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Tablet. BP-NORM Atenolol … 50mg (Reg. # 071447)	5968P485	M/s Neutro Pharma (Pvt) Ltd. 9.5-Km Sheikhupura Road Lahore. (DML # 000576)	The sample has been declared Substandard on the basis of failed assay of Atenolol, &Adulterated as per Section 3 (a) (v) of The Drugs Act 1976 (confirmed presence of an undeclared active ingredient i.e.  Ciprofloxacin HCl)

Risk Statement:	The use of BP-NORM (Atenolol 50 mg), Batch No. 5968P485, presents a serious risk to public health, particularly for patients with cardiovascular diseases such as hypertension, ischemic heart disease, arrhythmias, and the elderly who depend on consistent atenolol therapy. The product is substandard due to failed assay of atenolol, which may result in loss of therapeutic control, and is adulterated by the confirmed presence of an undeclared active ingredient, Ciprofloxacin HCl. This may expose patients to unintended antibiotic intake, leading to adverse reactions, drug interactions, and development of antimicrobial resistance, especially in vulnerable patients. Continued use of this batch may therefore cause significant harm, warranting immediate risk mitigation.
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.

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

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

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VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No I/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.

Salateen Philip Recall Alerts January 14, 2026January 22, 2026Recall

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DRUG PRODUCTS DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES PUNJAB.

DRAP Alert No	No II/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	No I/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

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	No II/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.

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	No II/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.

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

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

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DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUGS TESTING LABORATORY.

DRAP Alert No	No II/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.

120. Recall Alert (Class-I) – Drug Products (Human) Substandard by DTL Punjab.

Salateen Philip Recall Alerts December 16, 2025December 16, 2025Recall

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DRUG PRODUCTS DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES PUNJAB.

DRAP Alert No	No II/S/12-25-120
Action Date	16 December, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratories, Punjab 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.	Injection Neudex Dexamethasone Sodium Phosphate eq. to Dexamethasone Phosphate: 4mg/ml (Reg. # 32876)	DX029, DX039, DX040, DX041, DX033, DX031, DX045, DX042, DX044, DX046, DX047, DX048, DX049, DX050, DX051, DX053, DX052, DX060, DX059.	M/s Neutro Pharma (Pvt) Ltd. 9.5-Km Sheikhupura Road Lahore. (DML # 000576)	The sample is declared as “Adulterated” as per section 3 (iv) of The Drugs Act 1976.
2.	Injection Ame-Pin Each 2ml contains: Tramadol HCI… 100 mg (Reg. # 065943)	TD-042	M/s Ameer Pharma (Pvt) Ltd. 23-Km Sheikhupura Road, Lahore. (DML # 000604)	The sample “Sub-Standard” on the basis “Particulate contamination” visible particles” as per BP.

Risk Statement:	The use of Injection Neudex (Dexamethasone) declared as adulterated, and Injection Ame-Pin (Tramadol) found sub-standard due to visible particulate contamination, poses a serious risk to patient safety, particularly among critically ill patients, surgical patients, emergency care recipients, elderly individuals, and those with compromised immunity. Administration of adulterated or contaminated injectable products may result in treatment failure, severe allergic reactions, embolism, infections, organ toxicity, or even fatal outcomes. Healthcare professionals and patients are therefore urged to immediately discontinue use of the affected batches to prevent any potential adverse health consequences.
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.

119. Recall Alert (Class-II) – Drug Products (Human) Substandard -DTL Punjab

Salateen Philip Recall Alerts December 16, 2025December 16, 2025Recall

Recall Alert

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DRUG PRODUCTS DECLARED SUBSTANDARD BY DRUG TESTING LABORATORIES PUNJAB.

DRAP Alert No	No II/S/12-25-119
Action Date	16 December, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Drug Testing Laboratories, Punjab 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.	Tablet Ascard 75 mg Each Enteric Coated Tablet Contains: Acetylsalicylic Acid (Aspirin BP) ….75mg (Reg. # 016600)	AR034L	M/s Atco Laboratories Limited, B-18 S.I.T.E Karachi. (DML # 000537)	The sample is declared as “sub-standard” on the basis of Test for Related Substances (Impurity C: Salicylic Acid).
2.	Sachet PREVASMA  Each Sachet Contains: Montelukast Sodium USP eq. to Montelukast …………………………….. 4.0 mg (Reg. # 074838)	033	M/s MKB Pharmaceuticals (Pvt) Ltd. 66-Hayatabad Industrial Estate Jamrud Road Peshawar. (DML # 000617)	The sample is declared as “sub-standard” on the basis of Test for Impurities i.e. Organic Impurities.

Risk Statement:	The use of the above-mentioned sub-standard therapeutic goods may pose a potential risk to public health, particularly among patients requiring regular and long-term therapy. Tablet Ascard 75 mg is commonly prescribed for cardio-protective purposes, especially in patients with ischemic heart disease, history of stroke, hypertension, and diabetes, where the presence of excess Salicylic Acid impurity may increase the risk of gastro-intestinal irritation, bleeding tendencies, and hypersensitivity reactions. Similarly, Sachet PREVASMA (Montelukast 4 mg) is primarily used in children and patients with asthma and allergic conditions, and the presence of organic impurities beyond specified limits may lead to reduced therapeutic efficacy, unexpected adverse reactions, or worsening of respiratory symptoms. Therefore, children, elderly patients, cardiac patients, asthmatics, and individuals on chronic medication represent the population most likely to be affected, and immediate regulatory action including recall, market monitoring, and patient safety communication is warranted to mitigate potential health risks.
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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