Class 4 Medicines Defect Notification: Hikma Farmacêutica, Gemcitabine 2g/52.6ml concentrate for solution for infusion, EL(25)A/43

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.

DMRC Number: DMRC-38220370

Company name:Viatris Products Ltd

Product descriptions: 

Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe - PLGB: 46302/0230, SNOMED code: 13565111000001103, GTIN: 05016695926704

Arixtra 2.5 mg/0.5 ml solution for injection, pre-filled syringe - PLGB: 46302/0231, SNOMED code: 4332811000001106, GTIN: 05016695926759

Arixtra 5 mg/0.4 ml solution for injection, pre-filled syringe - PLGB: 46302/0232, SNOMED code: 9205511000001101, GTIN: 05016695926698

Arixtra 7.5 mg/0.6 ml solution for injection, pre-filled syringe - PLGB: 46302/0233, SNOMED code: 9205811000001103, GTIN: 05016695926674

Arixtra 10 mg/0.8 ml solution for injection, pre-filled syringe - PLGB: 46302/0229, SNOMED code: 9206111000001104, GTIN: 05016695926681

Details of the affected batches:

All batches of Arixtra solution for injection, pre-filled syringe within expiry date are affected.

Background information: 

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 (as illustrated in Figure 1 of recall document).

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.

Advice to 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.

Advice to 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 of recall document), 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.

Company contacts for further information: 

For medical information enquiries please telephone Viatris UK Healthcare Limited Medical Information on +44 (0)1707 853 000 (select option 1) or email info.uk@viatris.com.

For stock control enquiries please contact telephone Customer Services on +44 (0)1707 853 000 (select option 2).

To access the full recall/alert: Class 4 Medicines Defect Notification: Viatris Products Ltd, Arixtra solution for injection, pre-filled syringes, EL(26)A/04