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Medicines defect noticeMHRA

Mycophenolate Mofetil 1g/5ml Oral Suspension defect notice over a strength or dose problem

Wrong strength or doseLow riskClass 4

Rosemont Pharmaceuticals Limited has informed the MHRA that the Press-In-Bottle-Adaptor (PIBA) supplied with the batches listed above may cause the medicine to leak when attempting to withdraw a dose.

Check your product

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

19 identifiers listed for this notice.

  • Mycophenolate Mofetil 1g/5ml Oral Suspension 175ml

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • MYC23001
    • MYC24001
    • MYC24002
    • MYC24003
    • MYC24004
    • MYC24005
    • MYC24006
    • MYC24007
    • MYC24008
    Product licenceThe PL number on the carton.
    • PLGB 00427/0272
    ExpiryOn the carton, blister or label.
    • May 2025
    • Jun 2025
    • Jul 2025
    • Aug 2025
    • Dec 2025
    First distributedOn the product, its label or its packaging.
    • May 2024
    • Jun 2024
    • Sep 2024
    • Not yet distributed

What to do now

The problem with Mycophenolate Mofetil 1g/5ml Oral Suspension is strength: the dose in the affected batches may be higher or lower than the label says.

  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. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.

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

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.

If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/59). Quoted as issued.

Summary

Rosemont Pharmaceuticals Limited has informed the MHRA that the Press-In-Bottle-Adaptor (PIBA) supplied with the batches listed above may cause the medicine to leak when attempting to withdraw a dose.

The risk

DMRC reference number DMRC-33616486 Company name

Advice for healthcare professionals

Healthcare professionals should continue to prescribe the product, the batches listed are not being recalled. The PIBA is an aid to dispensing and the product can be administered accurately using the syringe without the PIBA.

Specific ‘Advice for patients’ is included in this alert for the safe and accurate administering the product. Please provide these instructions to patients when dispensing the product.

The specific instructions in the Patient Information Leaflet (PIL) for cleaning the syringe between administration of doses should continue unchanged.

If you have received one of the affected batches in the table, it is important to continue to take your medicine as prescribed by your healthcare professional. Stopping this medication suddenly can make you ill. This product is not being recalled and the following instructions below allow for the continued safe use of the product

The PIBA is the small plastic part included in the package with your medication. It is designed to fit tightly in the neck of the bottle to reduce mess when drawing up doses.

Bottles already in use

If you have already opened a bottle of the product, leave the PIBA in the bottle and continue to use as directed in the Patient Information Leaflet (PIL) that comes with your medicine. Removing the PIBA will increase the risk of damaging the plastic.

New bottles not yet opened

The PIBA helps with drawing up the correct dose of medicine but it not necessary to get an accurate dose. The product can be drawn up accurately using the syringe without the PIBA. Please follow the instructions below to get the right amount directly from the medicine bottle:

Discard the PIBA provided.

Shake the bottle well, immediately prior to use.

Remove the cap by pressing it down and turning anticlockwise.

Advice for patients

If you have received one of the affected batches in the table, it is important to continue to take your medicine as prescribed by your healthcare professional. Stopping this medication suddenly can make you ill. This product is not being recalled and the following instructions below allow for the continued safe use of the product

The PIBA is the small plastic part included in the package with your medication. It is designed to fit tightly in the neck of the bottle to reduce mess when drawing up doses.

Bottles already in use

If you have already opened a bottle of the product, leave the PIBA in the bottle and continue to use as directed in the Patient Information Leaflet (PIL) that comes with your medicine. Removing the PIBA will increase the risk of damaging the plastic.

New bottles not yet opened

The PIBA helps with drawing up the correct dose of medicine but it not necessary to get an accurate dose. The product can be drawn up accurately using the syringe without the PIBA. Please follow the instructions below to get the right amount directly from the medicine bottle:

Discard the PIBA provided.

Shake the bottle well, immediately prior to use.

Remove the cap by pressing it down and turning anticlockwise.

Keeping the bottle standing upright, insert the syringe supplied into the bottle ensuring the tip of the syringe goes below the level of the liquid.

Fill the syringe with a small amount of medicine by pulling the piston up whilst maintaining the tip of the syringe below the level of the liquid, then push the piston down to remove any possible bubbles whilst keeping some medicine in the syringe.

Pull the piston upward to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor.

Open the MHRA notice

Questions

Why has Mycophenolate Mofetil 1g/5ml Oral Suspension been recalled?

The problem with Mycophenolate Mofetil 1g/5ml Oral Suspension is strength: the dose in the affected batches may be higher or lower than the label says. A medicine that is weaker than stated may not control the condition it treats; one that is stronger may cause side effects.

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?

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?

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

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