Class 4 Medicines Defect Notification: B. Braun Melsungen AG, Meropenem 1000 mg powder and solvent for solution for infusion, EL(26)A/39
Read and act on the official notice on GOV.UK
Usually minor defects in packaging or other printed materials.
What all four recall classes mean
| Class | Action | The MHRA's definition |
|---|---|---|
| Class 1 | Immediate action | The defect presents a risk of death or disability. |
| Class 2 | Action within 48 hours | The defect may cause mistreatment or harm to the patient, but it is not life-threatening or serious. |
| Class 3 | Action within 5 days | The defect is unlikely to cause harm to the patient. |
| Class 4 this notice | Caution in use | Usually minor defects in packaging or other printed materials. |
A Class 1 recall usually comes with a National Patient Safety Alert. Source: MHRA, safety communications.
In plain English, for the pharmacy team
Why is this relevant to community pharmacy
Meropenem 1000 mg powder and solvent for solution for infusion is a hospital antibiotic. The issue is not with the medicine itself, but with some patient leaflets saying the wrong sodium content and the wrong strength. This affects pharmacists and dispensers because packs may have the affected leaflet included, and staff may need to be aware when supplying or administering it.
What to tell patients
Use your professional judgement for each patient.
- Keep taking this medicine as your healthcare professional tells you.
- This problem does not affect the quality of the solution for infusion.
- If you have questions or concerns, contact your Outpatient Parenteral Antimicrobial Team (OPAT) team first.
- Do not stop taking your medicine without speaking to the healthcare professionals involved in your treatment.
- If you have an adverse reaction or any questions about your medicine, seek medical attention.
- Report any suspected side effects through the Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card scheme.
What needs to be done
- Check stock for the batches listed in the notice and be aware that all available stock contains the affected version of the patient leaflet.
- Pharmacists: continue to supply and use the product in line with the approved Summary of Product Characteristics (SmPC), as the notice says the problem is only in the leaflet and does not affect the medicine itself.
- When dispensing or administering, take the incorrect leaflet information into account, especially for new patients.
- If packs are supplied from the affected batches, B. Braun can provide hard copies of the updated Patient Information Leafleat (PIL) so packs can be supplied with the correct leaflet.
- Make sure staff know the notice says the correct strength is shown on the pack and in the relevant PIL heading, even though section 6 of the leaflet is wrong.
- Report any suspected adverse reactions via the MHRA Yellow Card scheme, if relevant.
- Read and act on the official GOV.UK notice.
Pharmshark summary, checked and approved by Chris Dotchin on 2 Nov 2026. It is not the official notice: always read and act on the GOV.UK notice.
How this summary was written
An AI tool drafted it from the MHRA's own notice and nothing else. A second check compared every line with the notice. Pharmshark's clinical lead then read it against the notice, edited it where needed and approved it. If the MHRA changes the notice, this summary is taken down until it has been checked again.
The MHRA's 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.
Affected batches
As listed by the MHRA, exactly as published. Always check against the GOV.UK notice before acting.
| Batch number | Expiry | Pack size | First distributed |
|---|---|---|---|
| Meropenem 1000 mg powder and solvent for solution for infusion | |||
| 25J00360 | 31/10/2026 | 24 | 20/06/2025 |
| 25J01305 | 31/01/2027 | 24 | Not yet distributed |
| 25J02333 | 31/03/2027 | 24 | 12/01/2026 |
| 25J02595 | 31/03/2027 | 24 | Not yet distributed |
| 25J02331 | 31/03/2027 | 24 | Not yet distributed |
| 25J02332 | 31/03/2027 | 24 | Not yet distributed |
| 25J02335 | 31/03/2027 | 24 | Not yet distributed |
MHRA's audience tags: Dispensing GP practices, Pharmacy