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

Product descriptions:

Gentamicin 3mg/ml solution for infusion, PL 03551/0117

 

Gentamicin 3mg/ml solution for infusion, PL 03551/0117

 

Glucose Intravenous Infusion BP 5% w/v, PL 03551/0059

 

Ibuprofen 400mg Solution for Infusion, PL 03551/0152

 

Ibuprofen 600mg Solution for Infusion, PL 03551/0153

 

Ibuprofen 200mg Solution for Infusion, PL 03551/0155

 

Paracetamol 10mg/ml Solution for Infusion, PL 03551/0128

 

Sodium Chloride 0.9% w/v Intravenous Infusion BP, PL 03551/0088

 

Water for Injections BP, solvent for parenteral use, PL 03551/0077

 

Fluconazole 2mg/ml solution for infusion, PL 03551/0115

Brief description of 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 to 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 to 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.

Company contacts for 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

To access the full recall: Class 2 Medicines Recall: B. Braun Medical Ltd, Various Products, EL(23)A/27