FDA-Drug2017-11-01Class II

ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11

Becton Dickinson & Company
Hazard

Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)

Sold states
IL, MO, PA, TN, & VA
Affected count
628,000 applicators
Manufactured in
1 Becton Dr, N/A, Franklin Lakes, NJ, United States
Products
ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0029-2018

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