FDA recall D-004-2013

Carefusion 213, Llc · Class II · drug

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.

Reason for recall

Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.

Distribution

IL, MO, and NJ

Key facts

Status: Terminated
Initiation date: 2012-04-23
Report date: 2012-10-10
Termination date: 2013-09-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: El Paso, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-004-2013