FDA Recall D-0441-2025

CareFusion 213, LLC · El Paso, TX

Class II Ongoing 364 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.

Lot / code: Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026

Quantity: 385,200 applicators

Reason for recall

Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.

Recall record

Recall number: D-0441-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the U.S.
Recall initiated: 2025-05-15
Classified by FDA Center: 2025-05-20
FDA published: 2025-05-28
Recalling firm: CareFusion 213, LLC
Firm location: El Paso, TX

Drug identification

Brand name(s): CHLORAPREP ONE-STEP
Generic name(s): CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL
Manufacturer(s): CareFusion 213, LLC
NDC(s): 54365-400
Route(s): TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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