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Medicines defect noticeMHRA

Clarithromycin 250mg and 500mg film-coated tablets defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Strandhaven Limited t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Clarithromycin 250mg and 500mg film-coated tablets.

Check your product

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

88 identifiers listed for this notice.

  • Clarithromycin 250mg and 500mg film-coated tablets 14

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • ET207E2001
    • ET207E3001
    • ET207E3002
    • ET207E3003
    • ET208E1001
    • ET208E1002
    • ET208E1003
    • ET208E1004
    • ET208E1005
    • ET208E2001
    • ET208E2002
    • ET208E2003
    • ET208E2005
    • ET208E2004
    • ET208E2006
    • ET208E2007
    • ET208E2008
    • ET208E2009
    • ET208E2010
    • ET208E2011
    • ET208E2012
    • ET208E2013
    • ET208E2014
    • ET208E2015
    • ET208E2016
    • ET208E2017
    • ET208E2018
    • ET208E2019
    • ET208E2020
    • ET208E2021
    • ET208E2022
    • ET208E3001
    • ET208E3002
    • ET208E3003
    • ET208E3004
    • ET208E3005
    • ET208E3006
    • ET208E3007
    • ET208E3008
    • ET208E3009
    • ET208E3010
    • ET208E3011
    • ET208E3012
    • ET208E3013
    • ET208E3014
    • ET208E3015
    • ET208E3016
    • ET208E3017
    • ET208E3018
    • ET208E3019
    • ET208E3020
    Product licenceThe PL number on the carton.
    • PL 15764/0039
    • PL 15764/0040
    ExpiryOn the carton, blister or label.
    • Nov-25
    • Jun-26
    • Aug-26
    • Dec-26
    • Dec-24
    • Dec-25
    • Jan-26
    • Apr-26
    • Jul-26
    • Sep-26
    • Oct-26
    • Nov-26
    • Jan-27
    • Feb-27
    • Mar-27
    • Apr-27
    • May-27
    First distributedOn the product, its label or its packaging.
    • 14/09/2022
    • 08/02/2023
    • 08/05/2023
    • 15/09/2023
    • 05/06/2021
    • 01/04/2021
    • 13/05/2022
    • 24/05/2022
    • 08/07/2022
    • 11/08/2022
    • 18/11/2022
    • 14/12/2022
    • 09/01/2023
    • 17/03/2023
    • 12/04/2023
    • 28/04/2023
    • 08/07/2023
    • 15/07/2023

What to do now

The issue with Clarithromycin 250mg and 500mg film-coated tablets is information: something on the packaging or leaflet is wrong or missing.

  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

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(23)A/42). Quoted as issued.

Summary

Strandhaven Limited t/a Somex Pharma has informed the MHRA regarding an error with the Patient Information Leaflets (PILs) that have been packed in the listed batches of Clarithromycin 250mg and 500mg film-coated tablets.

The risk

MDR number MDR 055-11/23 Company name

Advice for healthcare professionals

There is no risk to product quality because of this issue, therefore the affected batches are not being recalled. Healthcare professionals are advised to exercise caution when dispensing the products and where possible, provide an updated PIL. The current PIL is being updated, therefore Strandhaven Limited t/a Somex Pharma do not immediately have any copies they can provide. If it is not possible to provide an updated PIL please advise patients of the missing information and discuss with them whether the medicine is suitable for them. Strandhaven Limited t/a Somex Pharma has confirmed that all future batches will contain the correct PIL.

No action is needed from patients. This issue is about missing information on the Patient Information leaflets (PILs) in specific batches of Clarithromycin 250mg and 500mg film-coated tablets, an antibiotic used to stop the growth of bacteria that cause infections. The medication itself is not affected.

These products will have been prescribed and dispensed by the qualified healthcare professional(s) responsible for your care.

If you have concerns about a medicine you may be using, please contact your healthcare professional. 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

No action is needed from patients. This issue is about missing information on the Patient Information leaflets (PILs) in specific batches of Clarithromycin 250mg and 500mg film-coated tablets, an antibiotic used to stop the growth of bacteria that cause infections. The medication itself is not affected.

These products will have been prescribed and dispensed by the qualified healthcare professional(s) responsible for your care.

If you have concerns about a medicine you may be using, please contact your healthcare professional. 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 Clarithromycin 250mg and 500mg film-coated tablets been recalled?

The issue with Clarithromycin 250mg and 500mg film-coated tablets is information: something on the packaging or leaflet is wrong or missing. 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?

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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