Recall Alert
| DRAP Alert No | No I/S/05-25-43 |
| Action Date | 20th May, 2025. |
| Target Audience | – National Regulatory Field Force. – Healthcare Professionals – Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
| Problem / Issue | The firm M/s Bayer Pakistan (Pvt.) Ltd., Karachi has requested for correction of a typographical error identified on the secondary packaging of Xarelto 15 mg Tablets, Batch Number BXK4E11. The error pertains to the incorrect indication of product strength on the outer label, which may lead to potential dosing errors. The details of the product are as under: |
Therapeutic Goods (s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Xarelto 15mg Tablet Reg. No. 072549 | Each film coated tablet contains: Rivaroxaban…15mg | BXK4E11 | M/s Bayer Pakistan Private Limited., Plot No. 23, Sector No.22, Korangi Industrial Area, Karachi. |
| Risk Statement: | Incorrect labeling can cause a patient to receive the wrong dosage of a medication. This may result in underdosing, where the medication is not effective, or overdosing, which can lead to harmful side effects or toxicity. |
| 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 the mentioned batch of product from the market. – All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying the mentioned batch. 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. |
| 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 the 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. |