According to the national drug regulator (Infarmed), the
batches in question are A841E, A841F, A841G, B841D, B841E, B841F, B841G and
B841H.
Infarmed recommends, according to the measures provided by
the manufacturer, the "immediate interruption of the ophthalmic solution
and its return to the acquisition establishment" although, according to
the evaluation carried out by the pharmaceutical company, "the effectiveness
and performance" of the drops are not affected, not constituting a health
risk.
The collection of targeted batches began "after a
decrease in the predicted concentration of ectoine, the main component of the
solution, and the presence of degradation products of this substance were
identified".
To date, according to Infarmed, "no cases of incidents
associated with the use of these lots have been reported".
However, Infarmed advises, "in case of any unwanted
side effect, such as eye irritation or conjunctivitis, contact a health
professional".
Ectodol Eye Drops work by "reducing inflammation of the
conjunctiva and regenerating irritated and sensitive conjunctiva".