Recall of batches of physiological serum: end of additional investigations, scope expanded

The drug agency announced on Monday, May 12, that it was expanding the scope of the physiological serum recall .

"Following our report, the competent Portuguese authority Infarmed carried out an inspection of the production sites of physiological serums from the manufacturer GSL," the ANSM said in a press release .

"This inspection highlighted in particular the insufficient mastery of good manufacturing practices , and in particular the fact that this manufacturer did not sufficiently control and document the cleaning process of the 96% ethanol manufacturing tanks."

Five brands concerned

Infarmad has assured that it will temporarily suspend the manufacture of serums for the brands Ainsifont , GSL , Happylab , Mediphysio and Stentil until the "correction of the detected irregularities" .

All batches produced at the GSL site are being recalled in France because they may "contain traces of cleaning alcohol ."

Please note that the manufacturer's name, GSL or Hidrodipro, appears on the label. Those who have purchased these products are encouraged to discard them or return them to their pharmacy or drugstore.