CHLORAPREP ONE-STEP BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v recall — FDA D-0441-2025
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
CGMP Deviations
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm…
cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm…
Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
Lack of Assurance of Sterility
cGMP deviations and lack of assurance of sterility.
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Presence of Particulate Matter
Presence of Particulate Matter: Glass particles were found in pellet vials.
cGMP deviations and lack of assurance of sterility.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Lack of Assurance of Sterility
Presence of Particulate Matter: Glass particles were found in pellet vials.
cGMP deviations and lack of assurance of sterility.
Presence of Particulate Matter: Glass particles were found in pellet vials.
cGMP deviations and lack of assurance of sterility.
Presence of Particulate Matter: Glass particles were found in pellet vials.
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health distribution…
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Lack of sterility assurance: Product leakage around the vial neck, which could potentially result in a lack of sterility assurance.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Labeling: Incorrect or Missing Lot and/or Expiration date: Individual vials of Dexonto 0.4%, are labeled correctly with the BUD of 12/25/2024, however, the outer box on some of the Dexonto…
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and…
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