Recall Alert
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. |