GovWire

MDR number

MDR 063-07/23

Company name

B. Braun Medical Limited

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

SNOMED Code

39394111000001103

Active Pharmaceutical Ingredient: Gentamicin Sulphate

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

SNOMED Code

39393811000001107

Active Pharmaceutical Ingredient: Gentamicin Sulphate

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

SNOMED Code

39369911000001101

Active Pharmaceutical Ingredient: Glucose Monohydrate

Ibuprofen 400mg Solution for Infusion, PL 03551/0152

SNOMED Code

41049911000001104

Active Pharmaceutical Ingredient: Ibuprofen

Ibuprofen 600mg Solution for Infusion, PL 03551/0153

SNOMED Code

41050211000001103

Active Pharmaceutical Ingredient: Ibuprofen

Ibuprofen 200mg Solution for Infusion, PL 03551/0155

SNOMED Code

41049611000001105

Active Pharmaceutical Ingredient: Ibuprofen

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

SNOMED Code

36088811000001109

Active Pharmaceutical Ingredient: Paracetamol

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

SNOMED Code

39456411000001100

Active Pharmaceutical Ingredient: Sodium Chloride

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

SNOMED Code

39504111000001103

Active Pharmaceutical Ingredient: Water for Injection

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

SNOMED Code

36076811000001100

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 suppliers 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

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