RecallRadar

FDA Drug recall D-0029-2018

ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso…

On 2017-11-01 the FDA classified a Class II recall of ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso… by Becton Dickinson And, citing 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).

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0029-2018
ClassificationClass II
Statusterminated
Initiated2017-09-15
Published2017-11-01
Last updated2026-09-13 11:51 UTC
CompanyBecton Dickinson And
DistributionIL, MO, PA, TN, VA

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

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)

Identifiers

code_infoLot 7096622, exp 3/21/2020

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0029-2018%22

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