Poland recalls batches of Olfen MAX gel over NDEA impurity — RMF24

In Poland, the Chief Pharmaceutical Inspector has recalled specific batches of the pain-relieving and anti-inflammatory gel Olfen MAX from circulation nationwide. According to RMF24, the decision concerns a medicine containing diclofenac sodium at a concentration of 20 mg/g, manufactured by Teva B.V.

The medicine is used to relieve pain after injuries. It belongs to non-steroidal anti-inflammatory drugs.

Reason for the recall

The reason was a quality non-compliance: the established limit for the NDEA impurity was exceeded. This is a nitrosamine impurity with potentially mutagenic and carcinogenic effects.

Due to the exceeded limit, the medicine does not meet the conditions for being placed on the market, and the safety of using the batches covered by the decision cannot be confirmed.

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Which batches are being recalled

The recall covers two batches of 50 g tubes: C51789A and C51790A. Both batches have an expiry date of 01.2027.

Also being recalled are 18 batches of 100 g packs: B72256A, B72257A, B72688A, B72475A, B72476A, B72563A, B72562A, B72687A and B72255A with an expiry date of 11.2026; C53995A, C53834B and C53835A with an expiry date of 02.2027; C54087A, C54088A, C53996A, C54216A, C54215A and C54217A with an expiry date of 03.2027.

The decision also includes five batches of 150 g tubes: B70993C and B70994A with an expiry date of 11.2026, as well as C53137A, C53136B and C53039B with an expiry date of 02.2027. The decision is subject to immediate enforcement.