Reported May 5, 2021 · Terminated
ChloraPrep With Tint 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 With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415
- Lot codes and dates
- Lot and Exp Date
176 of 176 codes
00117371/31/202300207391/31/202300237901/31/202300372781/31/202300372791/31/202300382091/31/2023004473412/31/2022000762510/31/2022000763012/31/202280956323/31/202181167234/30/202181276574/30/202181356515/31/202181375275/31/202181517415/31/202181586385/31/202181645306/30/202181786586/30/202181937796/30/202181975176/30/202181987657/31/202182128817/31/202182207377/31/202182265617/31/202182359918/31/202182499408/31/2021829556910/31/2021830450110/31/2021830484910/31/2021830669410/31/2021
- Lot and Exp Date
- Amount recalled
- 6,869,400 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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