Madrid (EFE).- The Spanish Agency for Medicines and Health Products (AEMPS) has reported on Wednesday the cessation of marketing and use of a batch of a chlorhexidine mouthwash for possible contamination with a bacterium, which may present risks for people with health problems or with a weakened immune system.
On its website and on the Twitter network, the AEMPS has specified that it is the mouthwash product chlorhexidine + XIlitol Imark in single-dose format for mouthwash (lot 0100320123), which is mainly distributed in the hospital channel, but its presence cannot be ruled out. out of it.
The AEMPS has ordered the manufacturer Imark-Hospita, SL to take precautionary measures to cease the marketing and use of the product, as well as the immobilization of all the units of the batch mentioned until confirming the absence of contamination by the Burkholderia cepacia bacterium.
It has also requested the manufacturer to initiate an investigation to clarify 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 this requirement, the company has ceased marketing the product and has communicated its immobilization in all the centers where it had been distributed.
