Apixaban 5mg Tablets
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 4 defect notification · DMRC-38614094
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Apixaban 5mg Tablets | PL: 04416/1608 | apixaban | |
| Apixaban 2.5mg Tablets | PL: 04416/1607 | apixaban |
Batches (expiry): PS2891 (30/06/2028), PT0565 (30/06/2028), PT1417 (31/07/2028), PU0476 (31/07/2028), PU0481 (31/08/2028), PV5375 (31/07/2028), PW1623 (31/07/2028), PW1624 (30/04/2028), PU1963 (31/07/2028), PU3287 (31/01/2028), PT4596 (31/07/2028), PT2868 (31/07/2028), PU2604 (31/07/2028), PU2605 (31/07/2028), PU2606 (31/07/2028), PT1722 (30/11/2027)
Background: Sandoz Ltd. have informed the MHRA that the Patient Information Leaflet (PIL) included in the affected batches of Apixaban does not contain up‑to‑date information relating to: The newly authorised paediatric indication (children aged 28 days to <18 years), and Updated guidance regarding use following spinal/epidural catheter removal.