107. Recall Alert – (Class-I) Injection Isobaj (Batch # IB-0925)

DRUG PRODUCTS DECLARED SUBSTANDARD BY CENTRAL DRUGS LABORATORY KARACHI.

DRAP Alert No	No I/S/11-25-107
Action Date	13 November, 2025.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	Central Drugs Laboratory informed that the sample of below mentioned drug product has been declared as ‘Substandard’.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch No.	Manufacturers	Remarks
1.	Isobaj Injection 10ml Each ml contains: Isosorbide Dinitrate ……. 1mg (Reg # 100721)	IB-0925	M/s Bajwa Pharmaceuticals (Pvt) Ltd. 36-Km Lahore Gujranwala Road Khori District Sheikhupura. (DML # 000805)	Sample is Sub-Standard on the basis “Bacterial Endotoxin test”.

Risk Statement:	The sample of Isobaj Injection 10 mL (Batch No. IB-0925) has been declared “Substandard” on the basis of failure in the Bacterial Endotoxin Test, indicating the possible presence of pyrogenic contamination. Use of such injectable preparations may cause fever, chills, hypotension, or severe adverse reactions, particularly in hospitalized, cardiac, or elderly patients for whom this product is commonly prescribed. As the defect directly affects the safety and quality of the product, the batch poses a high public-health risk and warrants an immediate Class I recall, with retrieval of all distributed stock to prevent potential harm to patients.
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.