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
000019212/31/2022000762112/31/2022000877512/31/2022000911112/31/2022001173812/31/2022001175312/31/2022001175412/31/2022001175512/31/2022001360412/31/2022001549812/31/2022001550012/31/202200163291/31/2023001792912/31/202200219451/31/202300288871/31/202300310931/31/202300346601/31/202300351491/31/202300364601/31/202300372721/31/202300382131/31/202300382171/31/202300418931/31/202300424831/31/202300425011/31/202300431051/31/202300447391/31/202300948382/28/202300980512/28/202301048593/31/2023
- Lot and Exp Date
- 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.
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