17. Volunatry Recall. Osilex-D (Glitz Pharma)

	VOLUNTARY RECALL OF DRUG PRODUCT

DRAP Alert No	No II/V/03-26-14
Action Date	11 March, 2026.
Target Audience	– National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public
Problem / Issue	M/s Glitz Pharma, 205, Muhammadi Plaza, College Road, Rawalpindi – Pakistan (Plant: Plot No. 265, Industrial Triangle Kahuta Road, Islamabad) has informed the Drug Regulatory Authority of Pakistan (DRAP) regarding voluntary recall of the following drug product due to quality defect observed during ongoing stability studies.

Therapeutic Goods (s) Affected: –

S#	Product Name	Batch	Manufacturers	Mfg. & exp. date
1.	Osilex D Manufacturing Date: August 2025 Expiry Date: July 2027.	T22125	M/s Glitz Pharma Plot No 265 Industrial Triangle Kahuta Road Islamabad. (DML # 000571)	The firm has initiated recall of the above-mentioned batch after observing changes in physical appearance during stability studies which do not comply with approved quality specifications.

Risk Statement:	The affected batch of Osilex D Tablet exhibited changes in physical appearance during stability studies. Although no adverse event has been reported, deviation from approved quality specifications may potentially compromise product quality, safety, and efficacy. The recall is being conducted as a precautionary measure to safeguard public health and ensure regulatory compliance.
Action Initiated	The field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batches from the market.
Advice for Healthcare Professionals	DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by batches of mentioned products. Adverse reactions or quality problems experienced with the use of above mentioned product are to be reported to the National Pharmacovigilance Centre (NPC), DRAP using Adverse Event Reporting Form or online through this link.  Further information of reporting problems to DRAP is available on this link.
Advice for Pharmacies/Medical stores: –	All pharmacists and chemist working at distributions and pharmacies should immediately check their stocks and stop supplying mentioned products. The remaining stocks should be quarantined and returned to the supplier/company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s).
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.