Skinsept Mucosa

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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.

Stability studies of batch 2434LH0503 showed an out-of-specification result for a single unidentified impurity and a borderline result for impurity K; the application to widen specification limits was rejected. Potential effects: possible quality non-compliance and uncertain treatment efficacy.

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