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FDAFDA · Food and drugs·Recall number D-0625-2026

BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.

Published July 1, 2026 · Recall initiated: May 28, 2026

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
CHLORAPREP ONE-STEP
Manufacturer
CareFusion 213, LLC
Distributor
Nationwide inthe USA, as well as other foreign distribution.
Lot
Lot # 4073005, Exp 03/31/2027
Risk classification
Class I
Area (FDA)
drug
Country
United States

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