Palifren Long
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
Recall Date
23.12.2025
Category
Medicines & supplements