Reported May 5, 2021 · Terminated

ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution…

CareFusion 213, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CareFusion 213, LLC · 1550 Northwestern Dr · El Paso, TX · 79912-8000

Is this the product you have?

  • ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400
Lot codes and dates
  • Lot and Exp Date

    842 of 842 codes

    • 0000192
    • 12/31/2022
    • 0007621
    • 12/31/2022
    • 0008775
    • 12/31/2022
    • 0009111
    • 12/31/2022
    • 0011738
    • 12/31/2022
    • 0011753
    • 12/31/2022
    • 0011754
    • 12/31/2022
    • 0011755
    • 12/31/2022
    • 0013604
    • 12/31/2022
    • 0015498
    • 12/31/2022
    • 0015500
    • 12/31/2022
    • 0016329
    • 1/31/2023
    • 0017929
    • 12/31/2022
    • 0021945
    • 1/31/2023
    • 0028887
    • 1/31/2023
    • 0031093
    • 1/31/2023
    • 0034660
    • 1/31/2023
    • 0035149
    • 1/31/2023
    • 0036460
    • 1/31/2023
    • 0037272
    • 1/31/2023
    • 0038213
    • 1/31/2023
    • 0038217
    • 1/31/2023
    • 0041893
    • 1/31/2023
    • 0042483
    • 1/31/2023
    • 0042501
    • 1/31/2023
    • 0043105
    • 1/31/2023
    • 0044739
    • 1/31/2023
    • 0094838
    • 2/28/2023
    • 0098051
    • 2/28/2023
    • 0104859
    • 3/31/2023
Amount recalled
40,720,900 cartons

This recall covers 8 products

The agency filed one notice per product. You are reading one of them; the other 7 are below.

Where it was sold

  • Nationwide

Why it was recalled

CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new CareFusion 213, LLC recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 29, 2022 · Data as of Sep 19, 6:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.