Pharmaceutical impurity recalls in Poland

Polish pharmaceutical regulators have initiated several actions involving the recall and withdrawal of medications due to the presence of nitrosamine impurities, which are potentially carcinogenic.

Initially, the Chief Pharmaceutical Inspector (GIF) ordered the recall of 25 batches of Olfen MAX, a diclofenac sodium topical gel. Stability testing revealed that levels of N-nitroso-diethylamine (NDEA) exceeded permissible limits in certain batches. Although the manufacturer, Teva B.V., proposed increasing allowable limits due to the topical nature of the product, regulatory authorities rejected the proposal.

Subsequently, the Chief Pharmaceutical Inspectorate withdrew all batches of the drug Dutilox (duloxetine) from the market and issued a temporary ban on new batches following reports of high nitrosamine levels. While the manufacturer, Farmak, has disputed the regulatory assessment, the withdrawal was implemented to mitigate contamination risks. Additionally, the Office for Registration of Medicinal Products (URPL) rejected a manufacturing change application from Polpharma for Disulfiram WZF, complicating the resolution of a long-standing shortage of that medication.