Class 2 Medicines Recall: B. Braun Medical Ltd, Various Products, EL(23)A/27
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.
MDR number
MDR 063-07/23
Company name
B. Braun Medical Limited
Gentamicin 3mg/ml solution for infusion, PL 03551/0117
SNOMED Code
39394111000001103
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 21025402 | 31/12/2023 | 120ml Ecoflac Plus | 01/03/2021 |
| 21056410 | 31/01/2024 | 120ml Ecoflac Plus | 16/03/2021 |
Active Pharmaceutical Ingredient: Gentamicin Sulphate
Gentamicin 3mg/ml solution for infusion, PL 03551/0117
SNOMED Code
39393811000001107
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 21056409 | 31/01/2024 | 80ml Ecoflac Plus | 04/10/2021 |
| 21427416 | 30/09/2024 | 80ml Ecoflac Plus | 10/06/2022 |
Active Pharmaceutical Ingredient: Gentamicin Sulphate
Glucose Intravenous Infusion BP 5% w/v, PL 03551/0059
SNOMED Code
39369911000001101
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 22041405 | 31/12/2024 | 50ml Ecoflac Plus | 04/05/2022 |
Active Pharmaceutical Ingredient: Glucose Monohydrate
Ibuprofen 400mg Solution for Infusion, PL 03551/0152
SNOMED Code
41049911000001104
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 21095409 | 29/02/2024 | 100ml Ecoflac Plus | 06/07/2021 |
Active Pharmaceutical Ingredient: Ibuprofen
Ibuprofen 600mg Solution for Infusion, PL 03551/0153
SNOMED Code
41050211000001103
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 21096410 | 29/02/2024 | 100ml Ecoflac Plus | 06/07/2021 |
Active Pharmaceutical Ingredient: Ibuprofen
Ibuprofen 200mg Solution for Infusion, PL 03551/0155
SNOMED Code
41049611000001105
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 22133402 | 28/02/2025 | 50ml Ecoflac Plus | 07/07/2022 |
Active Pharmaceutical Ingredient: Ibuprofen
Paracetamol 10mg/ml Solution for Infusion, PL 03551/0128
SNOMED Code
36088811000001109
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 21357402 | 31/08/2023 | 50ml Ecoflac Plus | 24/11/2021 |
| 21357403 | 31/08/2023 | 50ml Ecoflac Plus | 02/11/2021 |
| 21423402 | 30/09/2023 | 50ml Ecoflac Plus | 25/11/2021 |
| 21424401 | 30/09/2023 | 50ml Ecoflac Plus | 02/12/2021 |
Active Pharmaceutical Ingredient: Paracetamol
Sodium Chloride 0.9% w/v Intravenous Infusion BP, PL 03551/0088
SNOMED Code
39456411000001100
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 21261404 | 31/05/2024 | 50ml Ecoflac Plus | 16/09/2021 |
| 21384403 | 31/08/2024 | 50ml Ecoflac Plus | 29/10/2021 |
| 21433401 | 30/09/2024 | 50ml Ecoflac Plus | 21/12/2021 |
| 22123413 | 28/02/2025 | 50ml Ecoflac Plus | 11/05/2022 |
| 22165411 | 31/03/2025 | 50ml Ecoflac Plus | 27/05/2022 |
| 23104401 | 28/02/2026 | 50ml Ecoflac Plus | 24/05/2023 |
Active Pharmaceutical Ingredient: Sodium Chloride
Water for Injections BP, solvent for parenteral use, PL 03551/0077
SNOMED Code
39504111000001103
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 21231404 | 31/05/2024 | 100ml Ecoflac Plus | 05/10/2021 |
| 21387412 | 31/08/2024 | 100ml Ecoflac Plus | 23/12/2021 |
Active Pharmaceutical Ingredient: Water for Injection
Fluconazole 2mg/ml solution for infusion, PL 03551/0115
SNOMED Code
36076811000001100
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 21473402 | 31/10/2023 | 100ml Ecoflac Plus | 21/01/2022 |
| 22125401 | 29/02/2024 | 100ml Ecoflac Plus | 16/06/2022 |
Active Pharmaceutical Ingredient: Fluconazole
Brief description of the problem
B. Braun Medical Limited is recalling the specific product batches as a precautionary measure after traces of midazolam were detected in the batches listed in this notification. The listed product batches were manufactured following the manufacture of midazolam solution for infusion at the manufacturing facility and therefore some batches were detected to be contaminated with traces of midazolam above the Permitted Daily Exposure (PDE). Based on the analysis, all batches with a confirmed contamination above the safety threshold are included in this notification. Additionally, for solutions that could not be analysed, due to the lack of a reliable method, the batches are also being recalled as a precautionary measure, based on the theoretical risk of midazolam exceeding the safety threshold.
A toxicological assessment has been completed to evaluate the potential risk for patients. The assessment concluded that the highest detected levels of midazolam are deemed to display no clinical effects. Nevertheless, although at low risk, allergic reactions to Midazolam cannot be excluded. B. Braun Medical Limited has not received any reports of suspected adverse drug reactions for the affected batches.
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.
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.
Further Information
For stock control enquiries please contact via email or telephone: Josh Watts: Product Manager, email: josh.watts@bbraun.com or telephone: 07973 976257
For information about the recall please contact via email or telephone: Catherine Clulow: Local Vigilance and Project Coordinator, email: recalls.uk@bbraun.com or telephone: 0114 2259155
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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