February 2025 FDA Recall Chloraprep One-step by Carefusion 213, Llc
D-0259-2025 - Non-Sterility
This Class I drug recall was voluntarily initiated by Carefusion 213, Llc on February 14, 2025 for the product Chloraprep One-step. The FDA reported the reason for recall as non-sterility. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0259-2025
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
02-14-2025
03-19-2025
205,440 applicators
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
CareFusion 213, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Canada
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
Batch or Lot Expiration Information
Lot# : 3200240, Exp 6/30/2026
