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Medicines recallMHRA

Clarithromycin 500 mg powder for concentrate for solution for infusion recalled over a quality concern

Medicine quality concernHigh riskClass 2

Hameln Pharma Ltd is recalling certain batches of Clarithromycin 500 mg powder for concentrate for solution for infusion.

Check your product

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

78 identifiers listed for this notice.

  • Clarithromycin 500 mg powder for concentrate for solution for infusion 10

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 23J097
    • 23J098
    • 23J099
    • 23J100
    • 24A227
    • 24A230
    • 24E038
    • 24E039
    • 24E040
    • 24G130
    • 24G330
    • 24G331
    • 24G333
    • 24I243
    • 24I245
    • 24I400
    • 24I402
    • 24I403
    • 24I404
    • 24I418
    • 24K161
    • 24K162
    • 24K163
    • 24K164
    • 24K165
    • 24K166
    • 24K167
    • 24K168
    • 25D674
    • 25D675
    • 25F174
    • 25F175
    • 25F263
    ExpiryOn the carton, blister or label.
    • 30/09/2027
    • 30/11/2027
    • 31/12/2027
    • 31/01/2028
    • 29/02/2028
    • 30/04/2028
    • 30/06/2028
    • 31/07/2028
    • 30/09/2028
    • 31/10/2028
    • 30/11/2028
    • 31/03/2029
    • 31/05/2030
    First distributedOn the product, its label or its packaging.
    • 07/11/2023
    • 11/12/2023
    • 08/01/2024
    • 09/02/2024
    • 10/05/2024
    • 12/08/2024
    • 22/08/2024
    • 17/09/2024
    • 03/10/2024
    • 11/11/2024
    • 28/11/2024
    • 03/12/2024
    • 30/12/2024
    • 07/01/2025
    • 20/01/2025
    • 03/02/2025
    • 12/02/2025
    • 04/03/2025
    • 25/03/2025
    • 14/04/2025
    • 28/04/2025
    • 16/05/2025
    • 27/05/2025
    • 16/06/2025
    • 08/07/2025
    • 04/08/2025
    • 24/04/2025
    • 26/08/2025
    • 19/09/2025
    • 09/10/2025
    • 31/10/2025
    • 19/11/2025

What to do now

The MHRA has issued a notice about Clarithromycin 500 mg powder for 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. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.

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/53). Quoted as issued.

Summary

Hameln Pharma Ltd is recalling certain batches of Clarithromycin 500 mg powder for concentrate for solution for infusion.

The risk

DMRC reference number DMRC-37790612 Marketing Authorisation Holder

Advice for healthcare professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Hameln Pharma Ltd has not received an increase in reports of adverse events or product quality complaints in connection with these batches. The recall is being undertaken as a precautionary measure.

The recall only applies to the batch numbers listed in the table, which were manufactured with the affected raw material. Other batches of Clarithromycin 500 mg powder for concentrate for solution for infusion are not impacted.

Replacement batches of Clarithromycin 500 mg powder for concentrate for solution for infusion are available from Hameln Pharma Ltd and ongoing supplies will be maintained.

Patients are not required to take any action. This product is administered by healthcare professionals in a hospital or healthcare setting.

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 are not required to take any action. This product is administered by healthcare professionals in a hospital or healthcare setting.

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 500 mg powder for concentrate for solution for infusion been recalled?

The MHRA has issued a notice about Clarithromycin 500 mg powder for concentrate for solution for infusion. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.

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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