MHRA Class 2 Medicines Recall: Various Products (B.Braun Medical Ltd)

Drug alert number: EL (23)A/27

Date issued: 31 July 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for: various products manufactured by B.Braun Ltd.

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

Active Pharmaceutical Ingredient: Gentamicin Sulphate

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

Active Pharmaceutical Ingredient: Gentamicin Sulphate

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

Active Pharmaceutical Ingredient: Glucose Monohydrate

Ibuprofen 400mg Solution for Infusion, PL 03551/0152

Active Pharmaceutical Ingredient: Ibuprofen

Ibuprofen 600mg Solution for Infusion, PL 03551/0153

Active Pharmaceutical Ingredient: Ibuprofen

Ibuprofen 200mg Solution for Infusion, PL 03551/0155

Active Pharmaceutical Ingredient: Ibuprofen

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

Active Pharmaceutical Ingredient: Paracetamol

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

Active Pharmaceutical Ingredient: Sodium Chloride

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

Active Pharmaceutical Ingredient: Water for Injection

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

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.

Full drug alert can be viewed here.

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