The Spanish Agency for Medicines and Health Products (Aemps), which reports to the Ministry of Health, has issued a new alert after receiving a notification of the possible contamination of a well-known oral health product. Specifically, it is Colutorio Clorhexidina + Xilitol Imark-Formato Monodosis, single dose format, lot 0100320123, which would be contaminated with the Burkholderia cepacia bacterium.
“This bacterium can present risks for people with health problems or with a weakened immune system,” says Aemps in a statement. Thus, to avoid further problems, the Medicines Agency has ordered the manufacturer of the product, Imark-Hospital SL, to cease marketing and use of the product in a precautionary manner.
The Imark-Hospital mouthwash is distributed mainly through hospitals, however, the health alerts centres cannot rule out that it has been sold outside of it.
The AEMPS has asked the manufacturing company to immediately initiate an investigation with the aim of clarifying the causes of the possible contamination, and “to send samples of the affected batch, of the two previous ones and of the two subsequent ones for analysis”.
Given the seriousness of the matter, the company has decided to cease marketing the product and has notified the authorities of the immobilisation and cessation of its use in all the centres where it has been distributed.
Thus, as usual in these cases, the Medicines Agency has informed the health authorities of the 17 Spanish autonomous communities about the measures adopted to prevent its distribution.
If you do happen to have any of the products watching the batch number listed, you should not use it and should return it to the point of origin.
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