FDA DrugClass INotable

FDA Recall: BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA))

Date: 2026-07-01
Brand: CareFusion 213, LLC
Category: Drug
FDA Class: Class I

Description

Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Hazard

Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Remedy

178,000 applicators

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