German pharmaceutical company Bitop AG is recalling eight batches of Ectodol eye drops sold in Portugal after it found a decrease in the main component, the drug’s national regulator (Infarmed) said on Tuesday.
These are batches A841E, A841F, A841G, B841D, B841E, B841F, B841G and B841H, listed by the National Medicines and Health Products Administration (Infarmed) in an information circular from Monday posted on its website.
Infarmed recommends, in accordance with the measures provided by the manufacturer, “immediate discontinuation of the ophthalmic solution and its return to the institution of purchase”, although according to an assessment by the pharmaceutical company, the “efficacy and performance” of the drops are not affected, do not pose a health hazard.
Collection of target lots began “after detecting a decrease in the predicted concentration of ectoine, the main component of the solution, and the presence of degradation products of this substance.”
To date, according to Infarmed, “no incidents have been reported involving the use of these lots.”
However, Infarmed advises: “In the event of any unwanted side effect, such as eye irritation or conjunctivitis, seek medical attention.”
Ectodol eye drops reduce inflammation of the conjunctiva and regenerate irritated and sensitive conjunctiva.
Author: Portuguese
Source: CM Jornal
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