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Medicines defect noticeMHRA

Erythromycin Stearate BP 250mg Tablets, Amdipharm defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Amdipharm UK Ltd has informed MHRA that the Patient information leaflet (PIL) in the cartons for the batch listed in this notification includes a superseded PIL.

Check your product

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

3 identifiers listed for this notice.

  • Erythromycin Stearate BP 250mg Tablets, Amdipharm 100 Tablets/pack

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 6104532
    ExpiryOn the carton, blister or label.
    • 08/2028
    First distributedOn the product, its label or its packaging.
    • 04/09/2024

What to do now

There is an error on the label, carton or patient leaflet for Erythromycin Stearate BP 250mg Tablets, Amdipharm.

  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/32). Quoted as issued.

Summary

Amdipharm UK Ltd has informed MHRA that the Patient information leaflet (PIL) in the cartons for the batch listed in this notification includes a superseded PIL.

The risk

DMRC reference number DMRC-35918663 Marketing Authorisation Holder

Advice for healthcare professionals

There is no risk to product quality or impact to safety of the medicines listed in this notification because of this missing information. Healthcare professionals are advised to review the information contained within this notification and take this into account when dispensing this product.

If the medicines listed in this notification are dispensed, ensure that patients are aware of the missing information. Hard copies of the correct PIL will be provided by the Marketing Authorisation Holder upon request, so that any of the affected packs remaining in the dispensary can be supplemented with the correct PIL.

Amdipharm UK Ltd can provide printed copy of an updated PIL to HCP’s via medicalinformation@advanzpharma.com or telephone +44 (0) 208 588 9131.

Patients should be aware that some packs of Erythromycin Stearate BP 250mg Tablets (Erythrocin 250 Tablets) Batch 6104532 contain the incorrect Patient Information Leaflet (PIL). The missing safety information is listed in this notification and if you have any additional concerns relating to this information, please contact your pharmacist or prescriber.

The missing information, summarised in this notification, does not change or affect the quality of the product. Patients can continue to safely take this medicine unless they have concerns related to the missing information.

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

Advice for patients

Patients should be aware that some packs of Erythromycin Stearate BP 250mg Tablets (Erythrocin 250 Tablets) Batch 6104532 contain the incorrect Patient Information Leaflet (PIL). The missing safety information is listed in this notification and if you have any additional concerns relating to this information, please contact your pharmacist or prescriber.

The missing information, summarised in this notification, does not change or affect the quality of the product. Patients can continue to safely take this medicine unless they have concerns related to the missing information.

Patients who experience adverse reactions or have any questions about their 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 Erythromycin Stearate BP 250mg Tablets, Amdipharm been recalled?

There is an error on the label, carton or patient leaflet for Erythromycin Stearate BP 250mg Tablets, Amdipharm. 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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