PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: November 1, 2017 Initiated: September 15, 2017 #D-0029-2018

Product Description

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)

Details

Units Affected
628,000 applicators
Distribution
IL, MO, PA, TN, & VA
Location
Franklin Lakes, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Becton Dickinson & Company. Units affected: 628,000 applicators.
Why was this product recalled?
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)
Which agency issued this recall?
This recall was issued by the FDA Drug on November 1, 2017. Severity: Moderate. Recall number: D-0029-2018.