Medicines recallMHRA
Products recalled over a quality concern
B. Braun Medical Limited is recalling various product batches as a precautionary measure after traces of midazolam were detected in the batches listed in this notification.
Check your product
Only products that match these details are covered. Have your pack in front of you.
69 identifiers listed for this notice.
Product 1 120ml Ecoflac Plus
- Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
- 21025402
- 21056410
- Product licenceThe PL number on the carton.
- PL 03551/0117
- PL 03551/0059
- PL 03551/0152
- PL 03551/0153
- PL 03551/0155
- PL 03551/0128
- PL 03551/0088
- PL 03551/0077
- PL 03551/0115
- ExpiryOn the carton, blister or label.
- 31/12/2023
- 31/01/2024
- First distributedOn the product, its label or its packaging.
- 01/03/2021
- 16/03/2021
Product 2 80ml Ecoflac Plus
- Batch code
- 21056409
- 21427416
- Expiry
- 31/01/2024
- 30/09/2024
- First distributed
- 04/10/2021
- 10/06/2022
Product 3 50ml Ecoflac Plus
- Batch code
- 22041405
- 22133402
- 21357402
- 21357403
- 21423402
- 21424401
- 21261404
- 21384403
- 21433401
- 22123413
- 22165411
- 23104401
- Expiry
- 31/12/2024
- 28/02/2025
- 31/08/2023
- 30/09/2023
- 31/05/2024
- 31/08/2024
- 30/09/2024
- 31/03/2025
- 28/02/2026
- First distributed
- 04/05/2022
- 07/07/2022
- 24/11/2021
- 02/11/2021
- 25/11/2021
- 02/12/2021
- 16/09/2021
- 29/10/2021
- 21/12/2021
- 11/05/2022
- 27/05/2022
- 24/05/2023
Product 4 100ml Ecoflac Plus
- Batch code
- 21095409
- 21096410
- 21231404
- 21387412
- 21473402
- 22125401
- Expiry
- 29/02/2024
- 31/05/2024
- 31/08/2024
- 31/10/2023
- First distributed
- 06/07/2021
- 05/10/2021
- 23/12/2021
- 21/01/2022
- 16/06/2022
What to do now
The MHRA has issued a notice about Products.
- 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.
- If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
- 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(23)A/27). Quoted as issued.
Summary
B. Braun Medical Limited is recalling various product batches as a precautionary measure after traces of midazolam were detected in the batches listed in this notification.
The risk
MDR number MDR 063-07/23 Company name
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.
Based on the distribution dates, most of the affected stock will have been used already. B. Braun has confirmed that other stock which is not impacted remains available.
No action is required by patients as this is a Pharmacy and Wholesaler level recall. This product is administered by healthcare professionals directly. 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 required by patients as this is a Pharmacy and Wholesaler level recall. This product is administered by healthcare professionals directly. 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 Products been recalled?
The MHRA has issued a notice about Products. 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, 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?
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.