The Medicines and Healthcare products Regulatory Agency (MHRA) has issued “precautionary safety advice regarding possible contamination of certain eye gels” used to prevent the symptoms of dry eye.
It said last week (November 24) that eye gels containing carbomer branded by Aacarb, Aacomer and Puroptics “have a potential risk of microbial contamination, which can cause an infection if the gel is used”. See the lot or serial numbers of the recalled products below.
The MHRA said that the products are currently subject to “ongoing…investigations” to “determine if there is a link between the infections [that] have been identified and these products”.
The watchdog added that patients should “stop using” the gels “immediately” and that retailers should “withdraw affected products”. It said that the recall “is being taken as a precaution, and the risk to the general public is considered to be low”.
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And it stressed that patients who feel “unwell” and display eye infection symptoms like “reduced vision, red and painful eye” should “contact a healthcare professional” and tell them that they have been using a recalled eye gel.
It recommended that retailers should contact patients who have been dispensed any of the affected products to be returned.
Trion Pharma, which distributes Aacarb, asked for the product to be returned “back to the supplier where you have purchased” it. Distributor Essential-Healthcare, which manufactures Aacomer, declined to comment.
C+D also approached the Puroptics manufacturer Indiana Ophthalmic for comment.
“A small number of cases”
The regulator said that the “issue was identified” in an “ongoing investigation conducted by the UK Health Security Agency (UKHSA)” in which “a small number of cases of infection were identified”.
It said that the bacteria that “may have caused the microbial contamination” is Burkholderia cenocepacia, which it noted is more likely to cause adverse effects for “individuals with cystic fibrosis and patients with certain risk factors”.
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It said that UKHSA is recommending individuals in intensive care, who are waiting for lung transplants, have cystic fibrosis or are “severely immunocompromised” should avoid “all carbomer-containing lubricating eye gels”.
MHRA chief safety officer Alison Cave said that the regulator is “working very closely with our colleagues at UKHSA and will issue further advice to protect patients and the public, if needed”.
She added that “retailers should, where possible, contact patients who have been dispensed any of the affected batches and ask them to return the product".
The affected lot or serial numbers are:
- 3H02
- 3H03
- 3H04
- 3H05
- 3H06
- 3H07
- 3H08
- 3H09
- 3H10
- 3H11
- 3I02
- 3I03
- 3J07
- 3J08
- 3J09
- 3J23
- 3J24
- 3K01
- 3K02
