Recall Alert – Class II (Tablet Ascard-75) Batch # AR021L

PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES

DRAP Alert No	No II/S/09-25-77
Action Date	23 September, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Directorate of Drugs Control Punjab (DDCP) informed the Drug Regulatory Authority of Pakistan that the samples 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   Each enteric coated tablet contains: Acetylsalicylic Acid (Aspirin BP)……………75 mg	AR021L	M/s Atco Laboratories Limited, B-18 S.I.T.E Karachi. (DML # 000188)	‘Sub-Standard’ with regards to Related Substances Test (Impurity C: Salicylic Acid).

Risk Statement:	The Drug Testing Laboratory has declared the given sample as ‘substandard’ on basis of failure in the Related Substances Test, showing the presence of Impurity C (Salicylic Acid) beyond the permissible pharmacopeial limits. The presence of such impurity may lead to adverse effects including gastric irritation and related complications, particularly in sensitive patient populations. While not considered immediately life-threatening, this defect poses a significant quality concern that may cause temporary or medically reversible 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.