Medicine recalls
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| The United Kingdom: Specific brands of carbomer eye gel: recall of AACARB eye gel, AACOMER eye gel and PUROPTICS eye gel |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that specific batches of carbomer eye gels (manufactured by Indiana Ophthalmics LLP) are being recalled as a precaution due to possible microbiological contamination. The affected products are:
- AACARB eye gel (batch number: 3H07, 3H08, 3I02, 3I03)
- AACOMER eye gel (batch number: 3J23, 3J24, 3K01, 3K02, 3H02, 3H03, 3H04, 3H05, 3H06)
- PUROPTICS eye gel (batch number: 3H09, 3H10, 3H11, 3J07, 3J08, 3J09)
There is a potential risk of contamination of specific brands of carbomer eye gels with a type of bacteria called Burkholderia cenocepacia. An investigation has identified a potential association with these specific eye gels. Investigation and testing are still ongoing and these eye gels are being recalled as a precaution.
The risk to the general public from Burkholderia cenocepacia to be very low, but some patient groups (such as individuals with cystic fibrosis) are at higher risk of adverse effects. As a precautionary measure until further information is available, it is recommended that all carbomer containing eye gels are avoided where possible in individuals with cystic fibrosis; patients being cared for in critical care settings (e.g. intensive care), or who are severely immunocompromised and in hospital, and for patients awaiting lung transplantation. Non-carbomer containing lubricating products are available.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/specific-brands-of-carbomer-eye-gel-recall-of-aacarb-eye-gel-aacomer-eye-gel-and-puroptics-eye-gel-potential-risk-of-infection-dsi-slash-2023-slash-11
In Hong Kong, the above products are not registered pharmaceutical products. There is also no registered pharmaceutical product manufactured by Indiana Ophthalmics LLP.
Ends/Monday, Nov 27, 2023
Issued at HKT 15:00
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