Flunisolide Nasal Solution
Out of specification for related substances (impurities).
360 recalls · Class II, newest first
Out of specification for related substances (impurities).
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.