The drug security agency (ANSM) expanded, on Monday, May 12, the field of physiological serum brands to withdraw from the sale for quality defects after an inspection at the GSL manufacturer production sites.
On April 25, two physiological serum lots of the HappyLab brand of the sale had been eliminated due to a possible presence of alcohol cleaning traces in certain bottles.
After this report, the Portuguese Health Authority responsible for the safety of infarming medications carried out an inspection of the production sites of the physiological sera of the manufacturer GSL, said the ANSM.
This investigation revealed “the insufficient domain of good manufacturing practices, and in particular the fact that this manufacturer did not control and did not documented the process to clean the manufacturing tanks with 96%ethanol,” according to their press release.
Many brands withdrawn in pharmacies
Consequently, the ANSM recalls “all the lots produced in the GSL production site for all brands marketed in France, because it is likely that these products contain traces of alcohol cleaning.”
The brands produced by GSL and the Hydrodipro companies are worried: Ainsifont (44 lots), GSL (22 lots), HappyLab (41 lots in doses of 1l, 27 lots in doses 500 ml) Mediphysio (20 lots) and stentil (11 lots).
People who bought these products are invited to throw them or take them to their pharmacy or parapharmacy.
The Portuguese agency also remembers the physiological serum awards manufactured on this production site, underlines the ANSM.
Physiological serum is a salty solution that is often used to clean wounds, eyes, nose, including babies.
Source: BFM TV
