EMA Recalls Drug Batches for a Type of Eye Cancer

The National Medicines Organization (EOF) announced today (June 18, 2025) that it is recalling specific batches of the drug KIMMTRAK C/S.SOL.IN 100MCG/0.5ML (code 3321901), which do not meet the required specifications for treating a certain type of eye cancer. The recall was initiated due to out-of-specification results during stability testing of the product. According to the European Medicines Agency (EMA), this pharmaceutical product is used to treat adults with a form of eye cancer known as ‘uveal melanoma.’ It is utilized when the uveal melanoma cannot be surgically removed or has spread to other parts of the body. The decision by the organization is a precautionary measure aimed at supporting the voluntary recall already undertaken by the company. The recalled batches are: 3D009AA04, 3D009AA16, 3D009AA31, and 3D009AA39. MEDISON PHARMA MON. AE is required to immediately contact recipients and withdraw these specific batches from the market. Withdrawal documentation must be retained for at least five years and made available to EOF if requested.