BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin
Summary
The FDA issued a Class II for BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl by CareFusion 213, LLC. Reason: Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator..
Details
Source
Drug Recall
External ID
D-0441-2025
Action Date
2025-05-28
Status
Ongoing
Category
drug
Product Description
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 Info: Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
Quantity Affected: 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.
Distribution
Nationwide in the U.S.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-15
Company
El Paso, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
CareFusion 213, LLC has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CareFusion 213, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CareFusion 213, LLC have FDA actions?
CareFusion 213, LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0441-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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