22 FDA recalls mention Budesonide. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Budesonide.
Reason Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles…
Reason Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Reason Defective delivery system
Reason CGMP Deviations and Presence of Particulate Matter: Glass
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
Reason Lack of Assurance of Sterility
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Lack of Processing Controls
Reason Lack of Processing Controls
Reason Lack of Processing Controls
Reason Lack of Processing Controls
Reason Lack of Processing Controls
Reason Lack of Processing Controls
Reason Lack of Processing Controls
Reason Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution…
Reason Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Reason Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because…
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA…
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