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Medicines defect noticeMHRA

Gemcitabine 2g/52.6ml concentrate for solution for infusion defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.

Check your product

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

3 identifiers listed for this notice.

  • Gemcitabine 2g/52.6ml concentrate for solution for infusion 1

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • CB0033
    ExpiryOn the carton, blister or label.
    • 01/05/2026
    First distributedOn the product, its label or its packaging.
    • 05 August 2025

What to do now

There is an error on the label, carton or patient leaflet for Gemcitabine 2g/52.6ml concentrate for solution for infusion.

  1. Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
  2. Compare the batch number printed on the box or label with the batches listed here.
  3. If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
  4. Any side effect you think is linked can be reported through the 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(25)A/43). Quoted as issued.

Summary

Hikma Farmacêutica (Portugal) S.A has informed the MHRA that the Patient Information Leaflet (PIL) contained within batch CB0033 of Gemcitabine 2g/52.6ml concentrate for solution for infusion does not contain the side effects of serious skin reactions.

The risk

DMRC reference number DMRC-35799492 Marketing Authorisation Holder

Advice for healthcare professionals

Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing and dispensing this product, where possible.

Please see copies of the correct Patient Information Leaflet: GEMCITABINE PIL.

To request hard copies of the PIL, please contact customerserviceuk@hikma.com with your details, i.e. contact point, address, required number of leaflets.

This medicine is administered under the supervision of a healthcare professional who will be aware of the missing information in the Patient Information Leaflet (PIL).

Please see copies of the correct Patient Information Leaflet: GEMCITABINE PIL.

Patients who experience adverse reaction or have any questions about their medicine should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card Scheme

Advice for patients

This medicine is administered under the supervision of a healthcare professional who will be aware of the missing information in the Patient Information Leaflet (PIL).

Please see copies of the correct Patient Information Leaflet: GEMCITABINE PIL.

Patients who experience adverse reaction or have any questions about their medicine 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 Gemcitabine 2g/52.6ml concentrate for solution for infusion been recalled?

There is an error on the label, carton or patient leaflet for Gemcitabine 2g/52.6ml concentrate for solution for infusion. 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, 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?

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.

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