Health pulls famous eye drops from market

AEMPS has ordered the withdrawal from the market of three lots of single-dose containers of Ketobrill 0.25 mg/ml eye drops, used to treat the ocular symptoms of seasonal allergic conjunctivitis. The reason for this action was the discovery of quality deficiencies in the manufacturing process of the product, including the reuse of sterile filters without validating this practice.

According to AEMPS, the defect does not pose a life-threatening risk to patients but could compromise the sterility of the product and lead to eye infections. Users of this eye drop are therefore advised to check the batch number and expiry date on the packaging and, if it is one of the affected batches, return it to the pharmacy or point of sale where it was purchased.

The batches are manufactured by Pharma Stulln, which is also the marketing authorization holder for the drug. AEMPS classifies the defect as a Grade 2, which means it may have an impact on the patient’s health, although it is not serious. The agency has urged the autonomous region to monitor the recall and require laboratories to take necessary corrective actions to prevent this problem from happening again.

AEMPS reminds health professionals and citizens that they can report any suspected adverse reactions or problems related to drug use through the Spanish Pharmacovigilance System or through the spreadsheet available on its website.