FDA (Drugs) recall action 99114
The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Non-Sterility: Due to presence of Aspergillus penicillioides.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) due to wrinkles in the paper lidding that may breach the seal, compromising sterility assurance.
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) topical applicators due to non-sterility caused by the presence of Aspergillus penicillioides fungal contamination.
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) due to wrinkles in the paper lidding that may breach the seal area, compromising sterility assurance.
CareFusion is recalling 178,000 ChloraPrep One-Step antiseptic applicators (Lot #4073005) nationwide due to potential non-sterility from fungal contamination and seal breaches from paper lidding wrinkles.