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U.S. Department of Health and Human Services

Enforcement Report - Week of October 10, 2012

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Product Detail

Product Description 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.
Recall Number D-004-2013
Classification Class II
Code Info Lot 52894, Product Code: 260400
Product Distributed Qty 576 Cartons
Reason For Recall Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.

Event Detail

Event Id 62900
Product Type Drugs
Status Completed
Recalling Firm Carefusion 213, Llc
City El Paso
State TX
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-23
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern IL, MO, and NJ