Poland recalls Olfen MAX pain relief gel due to impurities

The Chief Pharmaceutical Inspector (GIF) in Poland has ordered the immediate recall of 25 specific batches of Olfen MAX, a topical pain relief and anti-inflammatory gel containing diclofenac sodium. The decision follows stability testing that revealed levels of N-nitroso-diethylamine (NDEA) exceeding permissible limits.

NDEA belongs to a group of nitrosamines that are subject to strict regulations due to their potential mutagenic and carcinogenic properties. Research indicated that NDEA levels in the product may increase over time; while the gel meets quality requirements for up to 18 months of storage, the recalled batches were originally distributed with a 24-month shelf life.

The recall affects various packaging sizes, including 50g, 100g, and 150g tubes, with expiration dates spanning late 2026 and early 2027. The responsible entity, Teva B.V., based in the Netherlands, had proposed increasing the allowable NDEA limit, arguing that the topical application limits systemic absorption, but this proposal was rejected by regulatory authorities.