HIGH

BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX...

Lack of assurance of Sterility: potential product contamination

Quick Facts at a Glance

Recall Date
April 22, 2026
Hazard Level
HIGH
Brands
PURPREP, CareFusion 213 LLC
Geographic Scope
1 states

Hazard Information

Lack of assurance of Sterility: potential product contamination

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact CareFusion 213, LLC or your healthcare provider for guidance. Notification method: Letter

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Full Description

BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41. Generic: POVIDONE IODINE AND ISOPROPYL ALCOHOL; Brand: PURPREP. Reason: Lack of assurance of Sterility: potential product contamination. Classification: Class II. Distribution: Nationwide in the USA

Safety Guide

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Product Classification

Product Details

Model Numbers
Lots# 4263873
Exp. Date 08-31-2026
4320590
Exp. Date 09-30-2026
4320591
+1 more
UPC Codes
54365-014
54365-014-42
54365-014-41
Affected States
ALL
Report Date
May 13, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE