FDA recall D-0644-2026

CareFusion 213, LLC · Class II · drug

Product

BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.

Reason for recall

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

Distribution

Distributed Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2026-06-11
Report date
2026-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
El Paso, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0644-2026