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
High riskUsing this product could cause serious injury, illness or death — stop using it now.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
258 of 258 codes
000877712/31/2022001632512/31/202200210721/31/202300270411/31/202300309591/31/202300310901/31/202300447351/31/202300480622/28/202300521102/28/202300563652/28/202300861482/28/202301048643/31/202301928946/30/202380815713/31/202180868513/31/202180877843/31/202180956203/31/202181067374/30/202181078194/30/202181249174/30/202181305094/30/202181318164/30/202181356465/31/202181418085/31/202181499925/31/202181559915/31/202181629125/31/202181639005/31/202181657216/30/202181767436/30/2021
- Lot and Exp Date
- Amount recalled
- 11,115,774 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
Stop using this product now
Microbial Contamination of Non-Sterile Product.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.
Using this product could cause serious injury, illness or death — stop using it now.
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