FDA recall D-0029-2018

Product

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

Reason for recall

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)

Distribution

IL, MO, PA, TN, & VA

Key facts

Status

Terminated

Initiation date

2017-09-15

Report date

2017-11-01

Termination date

2018-06-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Franklin Lakes, NJ, United States

Primary source

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