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Medicines recallMHRA

Class 4 Medicines Notification recalled over a labelling error

Labelling or leaflet error

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.

Check your product

Only products that match these details are covered. Have your pack in front of you.

11 identifiers listed for this notice.

  • Class 4 Medicines Notification 1 vial

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • P99834CE
    • P99834CJ
    • P99834CK
    • P99842CH
    Product licenceThe PL number on the carton.
    • PLGB 47104/0005
    ExpiryOn the carton, blister or label.
    • Mar 2025
    • Feb 2025
    • Sep 2025
    First distributedOn the product, its label or its packaging.
    • 7 March 2024
    • 17 Jun 2024
    • Not yet distributed

What to do now

There is an error on the label, carton or patient leaflet for Class 4 Medicines Notification.

  1. Keep taking your medicine unless a healthcare professional tells you otherwise.
  2. Check the batch number and expiry date on your pack against the list on this page.
  3. If it matches, your pharmacist can swap it or arrange an alternative.
  4. Report suspected side effects to the MHRA Yellow Card scheme.

Why it matters. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.

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(24)A/63). Quoted as issued.

Summary

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.

The risk

DMRC reference number DMRC-34131563 Company name

Advice for healthcare professionals

Healthcare professionals should only administer the product via the abdomen. This is described in the approved PIL and can be accessed electronically at VYVGART 1000 mg solution for injection - Patient Information Leaflet (PIL) - (emc) .

Any healthcare professionals providing the affected batches to patients for self-administration should advise patients to administer via the abdomen.

Patients should continue to take medicines from these batches as prescribed by your healthcare professional. This does not affect the quality of the product. Any patient who has received self-administration training should administer the product via the abdomen. This is described in the approved (correct) PIL and can be accessed electronically at VYVGART 1000 mg solution for injection - Patient Information Leaflet (PIL) - (emc) .

Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Advice for patients

Patients should continue to take medicines from these batches as prescribed by your healthcare professional. This does not affect the quality of the product. Any patient who has received self-administration training should administer the product via the abdomen. This is described in the approved (correct) PIL and can be accessed electronically at VYVGART 1000 mg solution for injection - Patient Information Leaflet (PIL) - (emc) .

Patients who experience adverse reactions or have any questions about the 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 Class 4 Medicines Notification been recalled?

There is an error on the label, carton or patient leaflet for Class 4 Medicines Notification. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.

How do I know if my medicine is affected?

Compare the batch code, product licence, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.

What should I do now?

Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.

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.

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