The Chief Pharmacist Inspectorate (GIF) has withdrawn selected batches of the Olfen MAX painkiller gel from sale across Poland. The reason is that the level of the impurity NDEA, a substance with potentially mutagenic and carcinogenic effects, exceeds the permitted limit.
The decision concerns Olfen MAX gel (diclofenac sodium, 20 mg/g), manufactured by Teva B.V. As RMF24 reports, citing PAP, the recall covers 50 g, 100 g and 150 g packs, and the decision has been given immediate enforceability. According to Naszemiasto.pl, GIF issued it on 12 October, and a total of 25 batches are being withdrawn.
What the defect is
NDEA (N-nitrosodiethylamine) belongs to the nitrosamines, impurities for which strict limits are set due to their possible mutagenic and carcinogenic effects. As GIF explained, this follows from stability studies: the limit was exceeded after 24 months from production. According to RMF FM, the product remains within the standards for 18 months of storage, while the withdrawn batches were placed on the market with a 24-month expiry date. GIF concluded that the safety of using these batches cannot be confirmed. The manufacturer tried to justify a higher permitted limit by pointing out that the gel is applied topically and the skin acts as a barrier.
Withdrawn batches
- 50 g tube (expiry 01.2027): C51789A, C51790A
- 100 g tube (until 11.2026): B72256A, B72257A, B72688A, B72475A, B72476A, B72563A, B72562A, B72687A, B72255A; (until 02.2027): C53995A, C53834B, C53835A; (until 03.2027): C54087A, C54088A, C53996A, C54216A, C54215A, C54217A
- 150 g tube (until 11.2026): B70993C, B70994A; (until 02.2027): C53137A, C53136B, C53039B
What it means for patients
The recall does not cover all packs with this name, only the batches named in the GIF decision. The batch number and expiry date are printed on the tube and box. If your batch is on the list, you should not use the gel. The product is used to relieve pain after injuries, and you can ask your pharmacy or doctor about alternatives and about returning a purchased medicine. According to reports, sale of the withdrawn batches is prohibited, so pharmacies are obliged to remove them from sale.
The available information does not indicate that any cases of harmful effects have been reported. As of publication, no statement from the manufacturer had been found.
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