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

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 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: Lots and Exp dates
220 of 220 codes
0009104
12/31/2022
0013602
12/31/2022
0016431
1/31/2023
0022273
1/31/2023
0023788
1/31/2023
0029135
1/31/2023
0032694
1/31/2023
0038211
1/31/2023
0044741
1/31/2023
0064598
2/28/2023
0104862
3/31/2023
0127010
4/30/2023
0196060
6/30/2023
0224915
7/31/2023
8024958
1/9/2021
8025595
1/31/2021
8025597
1/31/2021
8031857
1/31/2021
8033645
1/31/2021
8038971
1/28/2021
8043969
1/22/2021
8043978
1/31/2021
8046513
2/1/2021
8046721
1/29/2021
8053669
2/28/2021
8053699
2/28/2021
8053947
2/28/2021
8055949
2/28/2021
8059513
2/28/2021
8059562
2/28/2021
Amount recalled: 7,990,100 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.

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By hazard

Other recalls from CareFusion 213, LLC

16 in total.

All recall categories · Browse the whole archive