Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: Regent Medical Limited / Mölnlycke Health Care, Hibiwash 500ml |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Mölnlycke Health Care are recalling 3 batches of Hibiwash 500ml (chlorhexidine gluconate 4%) (batch number: 5156042, 5156043, 5156093) due to microbial contamination at the manufacturing facility, following routine weekly microbiological monitoring. The microbial contamination has been identified as Burkholderia cepacia. The investigation is ongoing, and to date no Hibiwash products have been found to be contaminated, however the batches at risk of contamination are being recalled as a precaution to mitigate any risks to public health.
Burkolderia cepacia is a gram-negative bacteria that is widely found in the environment, including soil and water, and has intrinsic resistance to many antibiotics. The risk to the general public from Burkholderia cepacia is considered very low, but some patient groups (such as individuals with cystic fibrosis or awaiting lung transplant) are at potentially increased risk of developing infections.
The use of the batches specified in this notification should be avoided. There have currently been no confirmed cases of Burkholderia cepacia infection in patients from the affected batches.
This product is also typically provided to patients pre-surgery for decolonisation and prevention of Staphylococcus aureus skin and soft tissue infections, and can be used for pre-operative surgical hand disinfection.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-regent-medical-limited-slash-molnlycke-health-care-hibiwash-500ml-el-26-a-slash-15
In Hong Kong, the above product in the MHRA announcement is not a registered pharmaceutical product.
Ends/Tuesday, Mar 24, 2026
Issued at HKT 17:30
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