Itami

GIF decision: Withdrawal from market, Marketing prohibition

What does this decision mean?

  • Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.
  • Zakaz wprowadzania — Selected batches are subject to a marketing prohibition — the product cannot be distributed to pharmacies.

The identified quality defect is insufficient adhesion of the patch to the skin; the patch does not remain firmly attached, preventing the product from fulfilling its intended therapeutic function. Potencjalne skutki: lack of treatment efficacy, possible recurrence or worsening of symptoms.

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Itami
Risk Level
Medium
Manufacturer
Fidia Farmaceutici S.p.A. z siedzibą w Padwie, Włochy
Batch Number
E03652,E03659,E03660,E03661,E04878,E04879,E04880,E04887,E04888,E04889,E04900,E05235,E05236,E05237,E05238,E05954,E05956,E05958
Notice Date
12.12.2025
View official statement

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