← FDA ENFORCEMENT
D-0517-2026Class II

CareFusion 213, LLC

Recalling firm
CareFusion 213, LLC
Product type
Drug
Status
Ongoing
Report date
2026-05-13
Distribution
Nationwide in the USA
Firm state
TX
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of assurance of Sterility: potential product contamination

Product description

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.

Code / lot 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.

Other recalls SPEQ maps to Environmental Monitoring
2026-07-22Class IFrutas y Hortalizas del Sur S.A.2026-07-22Class IIGELLERT GLOBAL GROUP2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC
See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.