RecallClass 4 · Caution in use
Class 4 Medicines Defect Notification: Viatris Products Ltd, Arixtra solution for injection, pre-filled syringes, EL(26)A/04
Read and act on the official notice on GOV.UK
Class 4 recall — Caution in use.
The MHRA uses Class 4 when:
Usually minor defects in packaging or other printed materials.
What all four recall classes mean
| Class | Action | The MHRA's definition |
|---|---|---|
| Class 1 | Immediate action | The defect presents a risk of death or disability. |
| Class 2 | Action within 48 hours | The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious. |
| Class 3 | Action within 5 days | The defect is unlikely to cause harm to the patient. |
| Class 4 this recall | Caution in use | Usually minor defects in packaging or other printed materials. |
A Class 1 recall usually comes with a National Patient Safety Alert. Source: MHRA, safety communications.
The MHRA's summary
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.
Affected batches
Use the GOV.UK notice for the batch numbers. Pharmshark could not list them safely from this notice (for example, they are in a PDF annex, or the table is laid out differently), so none are shown here.
What the notice says about its batches:
Arixtra 10 mg/0.8 ml solution for injection, pre-filled syringe: All batches of Arixtra solution for injection, pre-filled syringe within expiry date are affected.
MHRA's audience tags: Dispensing GP practices, Pharmacy