The Spanish Agency for Medicines and Health Products (AEMPS), which is part of the Ministry of Health, yesterday (Wednesday) ordered the withdrawal of a drug for eye symptoms. seasonal allergic conjunctivitis (Hay Fever), due to “unvalidated reuse of sterile filters in the manufacturing process”.
Affected drugs are Ketone Brill 0.25 mg/ml, eye drops, solution in unit dose containers, 20 unit dose containers, filled with 0.4 ml eye drops (NR: 77213, CN: 697080), manufactured by Pharma Stulln GMBH, Germany. Specifically, AEMPS has ordered the withdrawal of lot 21J004, which expires on Thursday, August 31; 22C049, which expires on February 28, 2024; and 22D022, which expires on March 31.
According to the package insert, Ketobrill “contains the active substance ketotifen hydrogen fumarate, an antiallergic substance indicated for the treatment of ocular symptoms of seasonal allergic conjunctivitis (hay fever).”
“It does not pose a risk to the patient’s health”
It should be remembered that Aemps classifies pharmaceutical quality defects into three categories (1, 2 and 3). In this case, the defect is classified as level 2 and therefore does not pose a risk to the patient’s health.
However, agencies under the Ministry of Health have ordered that all products of the affected batches be withdrawn from the market and subject to monitoring by the autonomous region, and returned to the laboratory through normal channels.