BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient P
Summary
The FDA issued a Class I for BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70 by CareFusion 213, LLC. Reason: Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding..
Details
Source
Drug Recall
External ID
D-0259-2025
Action Date
2025-03-19
Status
Ongoing
Category
drug
Product Description
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.
Lot/Code Info: Lot #: 3200240, Exp 6/30/2026
Quantity Affected: 205,440 applicators
Reason for Recall
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Distribution
Nationwide and Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-14
Company
El Paso, TX
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 61 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 I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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-0259-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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