31 FDA recalls mention Mannitol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Mannitol.
Reason Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Reason Super Potent and Failed Reconstitution Time
Reason Sub Potent
Reason Super Potent
Reason Sub Potent
Reason Product found to be Sub Potent or Exceeded reconstitution time
Reason Sub Potent
Reason CGMP deviations: Lack of potency testing.
Reason CGMP deviations: Lack of potency testing.
Reason CGMP deviations: Lack of potency testing.
Reason CGMP deviations: Lack of potency testing.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of sterility assurance.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility.
Reason Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
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