59 FDA recalls mention Orange. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Orange.
Reason Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
Reason Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
Reason Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead…
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
Reason cGMP deviations
Reason Labeling: Incorrect or Missing Package Insert
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Reason cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Reason cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Reason Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.
Reason SubPotent: Out of Specification
Reason SubPotent: Out of Specification
Reason SubPotent: Out of Specification
Reason SubPotent: Out of Specification
Reason SubPotent: Out of Specification
Reason SubPotent: Out of Specification
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