Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe
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-38220370
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe | PLGB: 46302/0230 | fondaparinux sodium | 05016695926704 |
| Arixtra 2.5 mg/0.5 ml solution for injection, pre-filled syringe | PLGB: 46302/0231 | fondaparinux sodium | 05016695926759 |
| Arixtra 5 mg/0.4 ml solution for injection, pre-filled syringe | PLGB: 46302/0232 | fondaparinux sodium | 05016695926698 |
| Arixtra 7.5 mg/0.6 ml solution for injection, pre-filled syringe | PLGB: 46302/0233 | fondaparinux sodium | 05016695926674 |
| Arixtra 10 mg/0.8 ml solution for injection, pre-filled syringe | PLGB: 46302/0229 | fondaparinux sodium | 05016695926681 |
Background: Viatris has received reports of brown discolouration and blockage in the needle of pre-filled syringes of Arixtra. This quality defect is related to oxidation of the syringe needle. The defect occurrence is estimated to be very rare. As Arixtra is considered critical to the continued supply of this medication, it will remain available for prescribing and is not being recalled from the market. Figure 1: Example of syringe with discolouration at the base of the needle