Medicines defect noticeMHRA
Arixtra solution for injection, pre-filled syringes defect notice over a packaging defect
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.
What to do now
A fault with the packaging or delivery device of Arixtra solution for injection, pre-filled syringes has been found.
- Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
- Compare the batch number printed on the box or label with the batches listed here.
- If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
- Any side effect you think is linked can be reported through the Yellow Card scheme.
Why it matters. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.
Symptoms and when to get help
Look out for
- a side effect you have not had before
- your condition not being controlled as well as usual
Get help urgently
- signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
- if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111
This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.
Replacements and prescriptions
If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself.
Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(26)A/04). Quoted as issued.
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.
The risk
DMRC reference number DMRC-38220370 Marketing Authorisation Holder
Advice for healthcare professionals
Follow the below handling precautions before dispensing or administering Arixtra:
Carefully inspect all Arixtra pre-filled syringes for discolouration at the needle base; if the needle base in the pre-filled syringe is discoloured (as illustrated in Figure 1), do not dispense or administer Arixtra and return it to your supplier using your supplier’s approved process.
Inform patients and caregivers of this quality defect and advise them on the handling precautions.
Carefully inspect all Arixtra pre-filled syringes for discolouration at the needle base. If the needle base in the pre-filled syringe is discoloured (as illustrated in Figure 1), do not administer Arixtra and return it to the pharmacy.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Advice for patients
Carefully inspect all Arixtra pre-filled syringes for discolouration at the needle base. If the needle base in the pre-filled syringe is discoloured (as illustrated in Figure 1), do not administer Arixtra and return it to the pharmacy.
Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Open the MHRA notice
Questions
Why has Arixtra solution for injection, pre-filled syringes been recalled?
A fault with the packaging or delivery device of Arixtra solution for injection, pre-filled syringes has been found. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.
How do I know if my medicine is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.
Do I need a new prescription?
If your pack is affected, your pharmacy can usually exchange it for an unaffected batch or another suitable product. Prescription medicines are replaced through your pharmacy or prescriber; you do not need to buy a new supply yourself. Many recalls are made at pharmacy or wholesaler level and do not require patients to act. The notice says which level applies.