Class 4 Medicines Notification: Argenx Bv, Vyvgart 1000 Mg Solution For Injection, El (24)a/63
Argenx BV is recalling Vyvgart 1000 mg solution for injection in the UK because the patient instruction leaflet incorrectly lists two possible injection sites when only the abdomen should be used. This affects patients who received packs with the incorrect leaflet.
- Recalling firm
- Argenx BV
- Reason
- Argenx BV have informed MHRA that the Patient Information Leaflet (PIL) in the affected packs incorrectly contains reference to two subcutaneous injection sites. Only subcutaneous injection to the abdomen is permitted.
- Classification
- Class III
- Category
- drug recall
- Country
- United Kingdom
- Agency
- UK Medicines and Healthcare products Regulatory Agency
- Recall date
- 2024-12-19
- Status
- Ongoing
- Distribution
- United Kingdom
Official recall notice from UK Medicines and Healthcare products Regulatory Agency
Recall details on Nibble Recalls: https://trynibble.app/recalls/46b118d8-5255-4b51-9d43-c219daf25783