drugs Class II Updated 2013-04-03

CareFusion 213, LLC recalls FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueou

Recalled 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots with expiry between 07/11 to 08/14.
View official government recall

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