85 FDA recalls mention Chlorhexidine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Chlorhexidine.
Reason Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
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 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 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 Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may…
Reason Non-Sterility: Due to presence of Aspergillus penicillioides.
Reason Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Reason Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Reason Lack of Assurance of Sterlity
Reason Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Reason Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Reason Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond…
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 Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
Reason Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing…
Reason CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of…
Reason CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of…
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