FDA recall D-229-2013

Product

FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per kit, packaged in 20 kits per carton, Cat. No 260288, NDC 54365-202-99, CareFusion, Leawood, KS 66211.

Reason for recall

Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.

Distribution

Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom

Key facts

Status

Terminated

Initiation date

2013-03-04

Report date

2013-04-03

Termination date

2014-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

El Paso, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-229-2013