FDA-Drug2014-07-23Class II

ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.

CareFusion 213, LLC
Hazard

Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.

Sold states
Nationwide in U.S.
Affected count
23,000 Applicators
Manufactured in
1550 Northwestern Drive, N/A, El Paso, TX, United States
Products
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1442-2014

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