Grofibrat 200

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• Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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

In long-term stability testing of Grofibrat 200, an out-of-specification (OOS) result was found for the active substance release parameter, meaning that quality requirements were not met during the shelf-life of batch H36032A. Potential effects: reduced treatment efficacy, possible disease progression, lack of expected therapeutic effect.

Download the app and stay informed

Get instant notifications about recalled products and protect your family.

App Store Google Play