DRAP Recall Alert-Substandard batches of Ascard 75mg, PREVASMA Sachets, Neudex injection and Ame-Pin injection
Recall Alert No. 119
Class-II Recall – Substandard Drug Products (Human)
DRAP Alert No.: II/S/12-25-119
Action Date: 16 December 2025
Target Audience
National Regulatory Field Force
Healthcare professionals including physicians, pharmacists, and nurses
General public
Reason for Recall
Drug Testing Laboratories (DTL), Punjab have declared certain drug samples as substandard after quality testing.
Affected Therapeutic Goods
Tablet Ascard 75 mg (Enteric Coated)
Each tablet contains Acetylsalicylic Acid (Aspirin BP) 75 mg
Registration No.: 016600
Batch No.: AR034L
Manufacturer: M/s Atco Laboratories Limited, B-18 S.I.T.E, Karachi
DML No.: 000537
Reason for failure: Declared substandard due to failure in Related Substances Test, specifically elevated Salicylic Acid (Impurity C)
Sachet PREVASMA
Each sachet contains Montelukast Sodium USP equivalent to Montelukast 4 mg
Registration No.: 074838
Batch No.: 033
Manufacturer: M/s MKB Pharmaceuticals (Pvt.) Ltd., Hayatabad Industrial Estate, Peshawar
DML No.: 000617
Reason for failure: Declared substandard due to organic impurities exceeding specified limits
Risk Statement
Tablet Ascard 75 mg is commonly used for cardiovascular protection, especially in patients with ischemic heart disease, previous stroke, hypertension, and diabetes.
Excess salicylic acid impurity may increase the risk of gastrointestinal irritation, bleeding tendencies, and hypersensitivity reactions, particularly during long-term use.
Sachet PREVASMA (Montelukast 4 mg) is primarily prescribed for children and patients with asthma and allergic conditions.
Presence of excessive organic impurities may result in reduced therapeutic efficacy, unexpected adverse reactions, or worsening of respiratory symptoms.
Children, elderly patients, cardiac patients, asthmatics, and individuals on chronic therapy are at higher risk.
Immediate recall, market monitoring, and patient safety communication are required to mitigate potential public health risks.
Recall Alert No. 120
Class-I Recall – Substandard / Adulterated Drug Products (Human)
DRAP Alert No.: II/S/12-25-120
Action Date: 16 December 2025
Target Audience
National Regulatory Field Force
Healthcare professionals including physicians, pharmacists, and nurses
General public
Reason for Recall
Drug Testing Laboratories (DTL), Punjab have reported serious quality defects in certain injectable products, declaring them adulterated or substandard.
Affected Therapeutic Goods
Injection Neudex (Dexamethasone Sodium Phosphate)
Strength: Equivalent to Dexamethasone Phosphate 4 mg/ml
Registration No.: 32876
Batch Nos.: DX029, DX039, DX040, DX041, DX033, DX031, DX045, DX042, DX044, DX046, DX047, DX048, DX049, DX050, DX051, DX053, DX052, DX060, DX059
Manufacturer: M/s Neutro Pharma (Pvt.) Ltd., 9.5-Km Sheikhupura Road, Lahore
DML No.: 000576
Quality issue: Declared adulterated under Section 3(iv) of the Drugs Act, 1976
Injection Ame-Pin (Tramadol HCl)
Strength: 100 mg per 2 ml
Registration No.: 065943
Batch No.: TD-042
Manufacturer: M/s Ameer Pharma (Pvt.) Ltd., 23-Km Sheikhupura Road, Lahore
DML No.: 000604
Quality issue: Declared substandard due to visible particulate contamination as per British Pharmacopoeia standards
Risk Statement
Use of adulterated or particulate-contaminated injectable products poses a serious and immediate threat to patient safety.
High-risk groups include critically ill patients, surgical and emergency care patients, elderly individuals, and immunocompromised patients.
Potential adverse outcomes include treatment failure, severe allergic reactions, embolism, infections, organ toxicity, and possible fatal outcomes.
Healthcare professionals and patients are strongly advised to immediately stop using the affected batches, isolate existing stock, and report any adverse events to regulatory authorities.
Actions Taken
The Regulatory Field Force has been instructed to conduct surveillance and seize the above-mentioned unregistered/falsified products.
Pharmacists, chemists, distributors, and healthcare professionals must urgently inspect their stocks. Details of suppliers of such products should be reported to the Regulatory Field Force (DRAP and Provincial Drug Control Departments) to ensure removal from circulation.
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.
Guidance for Healthcare Professionals
Any adverse events or quality concerns linked to these medicines should be reported to the National or Provincial Pharmacovigilance Centres via the Adverse Event Reporting Form or through the official online portal.
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How to download VigiMobile App for ADRs reporting
Guidance for Consumers
Consumers must avoid these products. If anyone experiences health problems after using them, they should immediately consult a healthcare provider and report the incident to DRAP / the National Pharmacovigilance Centre.
Always purchase therapeutic goods only from licensed pharmacies or authorized outlets. Carefully check the authenticity and condition of products, and consult a pharmacist or healthcare professional in case of doubt.
References:
Drug Regulatory Authority of Pakistan. (2025, December 16). Recall alert (Class-II) – Drug products (human) substandard – DTL Punjab (DRAP Alert No. II/S/12-25-119). https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/119-recall-alert-class-ii-drug-products-human-substandard-dtl-punjab/ Defence Housing Authority
Drug Regulatory Authority of Pakistan. (2025, December 16). Recall alert (Class-I) – Drug products (human) substandard by DTL Punjab (DRAP Alert No. II/S/12-25-120). https://www.dra.gov.pk/safety_info/product_recalls/recall_alerts/120-recall-alert-class-i-drug-products-human-substandard-by-dtl-punjab/
