Recall Alert: Recall of Nabaxo 10mg Film Coated Tablet Manufactured By M/s. Wenovo Pharmaceuticals, Taxila

Asad Ullah Recall Alerts November 15, 2024November 15, 2024

Recall Alert

DRAP Alert No	N^oI/S/11-24-48
Action Date	15^th November, 2024.
Target Audience	– National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public
Problem / Issue	Senior Drug Inspector Islamabad has informed DRAP that batch number 263 of product namely Nabaxo 10mg film coated tablet has been declared as out of specifications by Drug Testing Laboratory Rawalpindi. Details of test reports are as under:

Therapeutic Good(s) Affected: –

Product Names	Composition	Batch Details	Manufactured by
Nabaxo 10mg film coated tablet (Reg. No. 087751)	Rivaroxaban	Batch No.263	M/s. Wenovo Pharmaceuticals, Plot No. 31, 32, Punjab Small Industrial Estate, Taxila.

Risk Statement:	Nabaxo tablet contains Rivaroxaban is an anticoagulant medication used to treat and prevent blood clots. Rivaroxaban is used to treat deep vein thrombosis (blood clot, usually in the leg) and pulmonary embolism (blood clot in the lung) in adults. Substandard Rivaroxaban may lead to therapy failure in patients..
Action Initiated	-The regulatory field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product. –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.