BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate — Class I drug recall D-0344-2021

Terminated recall by CareFusion 213, LLC, reported 2021-05-05, distributed nationwide. Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, g

Recall number	`D-0344-2021`
Product type	Drug
Classification	Class I
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	CareFusion 213, LLC, El Paso, TX, United States
Recall initiated	2021-03-19
Classified	2021-04-26
Reported by FDA	2021-05-05
Terminated	2022-09-29
Distributed	Nationwide (US)
Countries outside the US	AE, BH, BR, CL, HK, KW, OM, QA, SG, ZA
Quantity	1,434,000 cartons
Reason classes	microbial contamination, labeling, sterility, packaging
Pathogens	mold
NDC	`54365-0400`, `54365-0400-33`
Lot numbers	`0107872`, `0108556`, `0148278`, `0151978`, `0155534`, `0157085`, `0160618`, `0167907`
Model numbers	`930415`

Product

BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415

Reason for recall

Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0344-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.