Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: B. Braun Medical Limited, various products |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that B. Braun Medical Limited is recalling various product batches as a precautionary measure after traces of midazolam were detected in the batches. The affected products are:
- Glucose Intravenous Infusion BP 5% w/v (batch number: 22041405)
- Paracetamol 10mg/ml Solution for Infusion (batch number: 21357402, 21357403, 21423402, 21424401)
- Sodium Chloride 0.9% w/v Intravenous Infusion BP (batch number: 21261404, 21384403, 21433401, 22123413, 22165411, 23104401)
- Water for Injections BP, Solvent for Parenteral Use (batch number: 21231404, 21387412)
- Fluconazole 2mg/ml Solution for Infusion (batch number: 21473402, 22125401)
- Gentamicin 3mg/ml Solution for Infusion (120ml Ecoflac Plus) (batch number: 21025402, 21056410)
- Gentamicin 3mg/ml Solution for Infusion (80ml Ecoflac Plus) (batch number: 21056409, 21427416)
- Ibuprofen 400mg Solution for Infusion (batch number: 21095409)
- Ibuprofen 600mg Solution for Infusion (batch number: 21096410)
- Ibuprofen 200mg Solution for Infusion (batch number: 22133402)
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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-b-braun-medical-ltd-various-products-el-23-a-slash-27
In Hong Kong, the following pharmaceutical products are registered by B. Braun Medical (HK) Ltd:
- Glucose Inj 5% (B. Braun) (HK-28238)
- Glucose Intravenous Infusion 5% (HK-55893)
- Paracetamol B. Braun Solution For Infusion 1000mg/100ml (HK-64407)
- Paracetamol B. Braun Solution For Infusion 500mg/50ml (HK-64408)
- Sodium Chloride Inj 0.9% (B. Braun) (HK-28240)
- Sodium Chloride Inj 0.9% (B. Braun) (HK-44881)
- Sodium Chloride Solution for Infusion 0.9% w/v (HK-66001)
- Water For Injection in Plastic Ampoule (HK-28212)
- Water For Injection in Glass Container (HK-28213)
- Water For Injections (HK-42631)
- Water For Inj (HK-57175)
- Water For Injections (HK-67283)
All products are prescription-only medicines. As confirmed with B. Braun Medical (HK) Ltd, the affected batches have not been imported into Hong Kong.
Fluconazol Farmoz Solution For Infusion 2mg/ml (HK-59031) is a pharmaceutical product containing fluconazole which is registered by Trenton-boma Ltd and manufactured by B. Braun. The product is a prescription-only medicine. As confirmed with Trenton-boma Ltd, the affected batches have not been imported into Hong Kong.
The gentamicin- and ibuprofen-containing products in the above MHRA’s announcement are not registered pharmaceutical products in Hong Kong.
Related news was previously issued by the Singapore Health Sciences Authority, and was posted on the Drug Office website on 29 Jul 2023.
Ends/Tuesday, Aug 1, 2023
Issued at HKT 15:00
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