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Medicines defect noticeMHRA

Meropenem 1000 mg powder and solvent for solution for infusion defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

B. Braun Melsungen AG has notified the MHRA that errors have been identified in the Patient Information Leaflet (PIL) included in some batches of Meropenem 1000 mg powder and solvent for solution for infusion.

Check your product

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

13 identifiers listed for this notice.

  • Meropenem 1000 mg powder and solvent for solution for infusion 24

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 25J00360
    • 25J01305
    • 25J02333
    • 25J02595
    • 25J02331
    • 25J02332
    • 25J02335
    ExpiryOn the carton, blister or label.
    • 31/10/2026
    • 31/01/2027
    • 31/03/2027
    First distributedOn the product, its label or its packaging.
    • 20/06/2025
    • Not yet distributed
    • 12/01/2026

What to do now

The issue with Meropenem 1000 mg powder and solvent for solution for infusion 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(26)A/39). Quoted as issued.

Summary

B. Braun Melsungen AG has notified the MHRA that errors have been identified in the Patient Information Leaflet (PIL) included in some batches of Meropenem 1000 mg powder and solvent for solution for infusion.

The risk

DMRC reference number DMRC- 40832810 Marketing Authorisation Holder

Advice for healthcare professionals

Healthcare professionals are advised to continue using B. Braun Meropenem 1000 mg powder and solvent for solution for infusion in accordance with the approved Summary of Product Characteristics (SmPC). Although section 6 of the Patient Information Leaflet (PIL) incorrectly refers to 500 mg, the correct strength (1000 mg) is stated on the product packaging and in the relevant PIL heading.

The identified issue is limited to incorrect information within sections 2 and 6 of the PIL, relating to the stated sodium content and product strength respectively. The issue does not affect the quality of the physical product formulation or efficacy of the medicinal product.

Healthcare professionals are advised to review the information contained within this notification and take this into account when dispensing or administering this product, especially for new patients.

Upon request, B Braun will provide hard copies of the updated PIL to wholesalers and pharmacies so that any packs can be supplemented with the correct PIL information. To request hard copies of the PIL, please contact medinfo.bbmuk@bbraun.com , or telephone 08002980299 with your details, i.e. address, product with batch details, required number of leaflets.

Patients should continue to take medicines from these batches as administered by your healthcare professional. This does not affect the quality of the solution for infusion.

If patients have concerns or questions, they should contact their Outpatient Parenteral Antimicrobial Therapy (OPAT) team in the first instance. Do not stop taking your medication without speaking to healthcare professionals involved in your treatment.

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 continue to take medicines from these batches as administered by your healthcare professional. This does not affect the quality of the solution for infusion.

If patients have concerns or questions, they should contact their Outpatient Parenteral Antimicrobial Therapy (OPAT) team in the first instance. Do not stop taking your medication without speaking to healthcare professionals involved in your treatment.

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 Meropenem 1000 mg powder and solvent for solution for infusion been recalled?

The issue with Meropenem 1000 mg powder and solvent for solution for infusion 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, 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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