Official recall notice
FDA DrugClass IINotable
FDA Recall: BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 5
- Recall date
- 2026-07-08
- Brand
- CareFusion 213, LLC
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product description
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Affected products
Lot: 4298581, expires: 09/30/2026.