AEMPS orders withdrawal of eye drops in Spain

The Spanish Medicines and Healthcare Products Agency, which is part of the Ministry of Health, has issued an alert informing about the withdrawal Several groups of drugs treat ocular symptoms of seasonal allergic conjunctivitis.

Affected drugs are Ketobrill 0.25 mg/ml eye drops, solution in single-dose container20 single-dose containers, filled with 0.4 ml eye drops (NR: 77213, CN: 697080), manufactured by Brill Pharma.

The reason for the withdrawal is “Reuse of sterile filters in the manufacturing process, but the reuse has not been validated“.

The batches affected by this withdrawal and the expiration dates for each product are:

• Batch: 21J004, valid until August 31, 2023
• Batch: 22C049, expiry date: February 28, 2024
• Batch: 22D022, expiry date March 31, 2024

The information has been transferred to the distribution and dispensing chain, and as a precautionary measure, all distribution units of the affected batches have been withdrawn from the market and returned to the laboratory “through normal channels”, while the Autonomous Region has been asked to “supervise” said withdrawal .

Aemps classifies pharmaceutical quality defects into three categories (1, 2, and 3).In this example, the defects are classified into 2 categories, so There is no risk to the patient’s health.

According to the drug’s 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).”