FDAClass IINovember 1, 2017

ChloraPrep OneStep recall: Labeling Error

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

Why was ChloraPrep OneStep 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)

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 7096622, exp 3/21/2020

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…
Recalling firm
Becton Dickinson & Company
Quantity
628,000 applicators
Distribution
IL, MO, PA, TN, & VA
Recall date
November 1, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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