FDA recall D-1442-2014

Product

ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.

Reason for recall

Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.

Distribution

Nationwide in U.S.

Key facts

Status

Terminated

Initiation date

2013-06-13

Report date

2014-07-23

Termination date

2015-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

El Paso, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1442-2014