April 2012 FDA Recall Drug by Carefusion 213, Llc
D-004-2013 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Carefusion 213, Llc on April 23, 2012 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in IL, MO, and NJ and the recall is currently terminated.

Recall Number: D-004-2013

Reason for Recall
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Initiated
04-23-2012
Reported
10-10-2012
Quantity
576 Cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62900
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.
Carefusion 213, Llc
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, and NJ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2013
Product Description About Product Description
Full technical description of the product.
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.

Batch or Lot Expiration Information

Lot# Lot 52894, Product Code: 260400