CareFusion 213, LLC: BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with is

CareFusion 213, LLC: BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per car

DrugsSource: FDA (drug) · Date: 2026-05-13

The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand: CareFusion 213, LLC
Product: BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.
Reason / hazard: Lack of assurance of Sterility: potential product contamination
Classification: Class II
Status: Ongoing
Distribution / sold at: Nationwide in the USA
Recall initiated: 2026-04-22
Code info: Lot# 4258309, 4260329, 4256875, Exp. Date, 08-31-2026; 4296453, 4317319, 4290654, Exp. Date 09-30-2026; 4322449, 4323861, 4318679, Exp Date 10-31- Exp.
Voluntary mandated: Voluntary: Firm initiated
City: El Paso
State: TX
Country: United States
Event id: 98790