September 2017 FDA Recall Drug by Becton Dickinson & Company (D-0029-2018 - 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))

This Class II drug recall was voluntarily initiated by Becton Dickinson & Company on September 15, 2017 for the product Drug. The FDA reported the reason for recall as 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). The product was distributed in IL, MO, PA, TN, & VA and the recall is currently terminated.

Recall Number: D-0029-2018

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)
Initiated
09-15-2017
Reported
11-01-2017
Quantity
628,000 applicators

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78124
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Becton Dickinson & Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
IL, MO, PA, TN, & VA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-27-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot 7096622, exp 3/21/2020