A dangerous substance in a popular painkiller gel. GIF warns

The Chief Pharmaceutical Inspectorate (GIF) has withdrawn selected series of Olfen MAX gel (diclofenacum natricum; 20 mg/g), manufactured by Teva B.V., from the market throughout the country. The decision concerns a preparation used to relieve post-traumatic pain, which is a non-steroidal anti-inflammatory drug (NSAID).

The reason for withdrawing the product was a quality defect consisting in exceeding the limit for the NDEA parameter. As stated in the announcement, NDEA is a nitrosamine impurity for which limits are set due to its mutagenic and carcinogenic potential. Exceeding this limit means that the product does not meet the conditions for marketing authorization and does not allow confirming the safe use of the series covered by the decision.

The decision applies to the following series of Olfen MAX gel:

Two series in 50 g tubes: C51789A, C51790A (expiration date: 01/2027)

Eighteen series in 100 g tubes: B72256A, B72257A, B72688A, B72475A, B72476A, B72563A, B72562A, B72687A, B72255A (dates until November 2026); C53995A, C53834B, C53835A (dates until February 2027); C54087A, C54088A, C53996A, C54216A, C54215A, C54217A (dates until 03/2027)

Five series in 150 g tubes: B70993C, B70994A (due until November 2026); C53137A, C53136B, C53039B (due until 02/2027)

The decision was made immediately enforceable.