drugs Class II Updated 2013-04-03

CareFusion 213, LLC recalls Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), N

Recalled Product

Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260311, NDC 54365-201-99, 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 09/11 to 09/13.
View official government recall

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