Polish pharmaceutical regulator recalls Olfen MAX gel

The Chief Pharmaceutical Inspectorate (GIF) has issued an urgent recall for 25 specific batches of the anti-inflammatory and analgesic gel Olfen MAX, produced by Teva B.V. The decision was made immediate to protect public health following stability tests.

Quality verification revealed that certain batches exceeded the permissible limit for N-nitroso-diethylamine (NDEA) contamination. NDEA is a compound belonging to the nitrosamine group, which is strictly monitored globally due to its potential mutagenic and carcinogenic properties. Testing indicated that NDEA levels in the product increase over time, specifically exceeding safety limits after 18 months of storage.