Palifren Long
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- • Wycofanie z obrotu — Some of the products covered by the decision were withdrawn from the market — please return them to the pharmacy/distributor.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.
An FDA inspection at the manufacturer revealed non-compliances in sterile/aseptic processing and procedures, posing a risk to the quality and sterility of Palifren Long prolonged-release injectable suspension products. Potential effects: infection after injection, severe systemic complications, lack of treatment safety.
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Risk Level
Critical
Manufacturer
Adamed Pharma S.A. z siedzibą w Pieńkowie
Batch Number
4500575, 4401275, 4400803, 4500970, 4500771, 4500442, 4401435, 4400975, 4501001, 4500827, 4500281, 4500097, 4400432, 4401151, 4401261, 4401098, 4401101, 4501375, 4501247, 4500835, 4500207, 4401407, 4400148, 4400147, 4301762, 4301763, 4401259, 4401260, 4400980, 4400804
Notice Date
23.12.2025
Category
Medicines & supplements
