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Medicines defect noticeMHRA

Sugammadex 100 mg/ml solution for injection (2 ml vial) defect notice over a packaging defect

Packaging or device defectLow riskClass 4

USV UK Limited has informed the MHRA that Sugammadex 100 mg/ml solution for injection (2 ml vial), batch number 35000347, may contain some vials that contain a low volume of solution; less than the label claim of 2 ml.

Check your product

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

4 identifiers listed for this notice.

  • Sugammadex 100 mg/ml solution for injection (2 ml vial) 1 x 10

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 35000347
    Product licenceThe PL number on the carton.
    • PL 32870/0059
    ExpiryOn the carton, blister or label.
    • 05-2025
    First distributedOn the product, its label or its packaging.
    • 22 August 2023

What to do now

A fault with the packaging or delivery device of Sugammadex 100 mg/ml solution for injection (2 ml vial) has been found.

  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. 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(24)A/02). Quoted as issued.

Summary

USV UK Limited has informed the MHRA that Sugammadex 100 mg/ml solution for injection (2 ml vial), batch number 35000347, may contain some vials that contain a low volume of solution; less than the label claim of 2 ml.

The risk

MDR number MDR 271-10/23 Company name

Advice for healthcare professionals

Healthcare professionals are advised to check stock levels of Sugammadex 100 mg/ml solution for injection (2 ml vials) with batch number 35000347 and consider that additional vials may need to be used to supplement the required dosage in line with the requirement of individual patient treatment.

Healthcare professionals are reminded of the information in Section 4.2 Posology and method of administration in the Summary of Product Characteristics (SmPC) .

Patients do not need to take any action. This product is given to patients by trained healthcare professionals. This notification is to provide healthcare providers with information that some vials may contain less than the labelled volume. There is no impact to patient safety, efficacy or product quality. Healthcare professionals will ensure that the appropriate dose is provided.

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 do not need to take any action. This product is given to patients by trained healthcare professionals. This notification is to provide healthcare providers with information that some vials may contain less than the labelled volume. There is no impact to patient safety, efficacy or product quality. Healthcare professionals will ensure that the appropriate dose is provided.

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 Sugammadex 100 mg/ml solution for injection (2 ml vial) been recalled?

A fault with the packaging or delivery device of Sugammadex 100 mg/ml solution for injection (2 ml vial) 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?

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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