drugs Class II Updated 2013-04-03

CareFusion 213, LLC recalls SEPP 10% Povidone Iodine Solution USP (1% available Iodine,

Recalled Product

SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, CareFusion, Leawood, KS 66211, Cat. No 260286, NDC 54365-145-01; and b) 3000-count applicators per case, Cat. No 260681, 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: a) All lots with expiry between 09/12 to 10/15 and b) All lots with expiry between 10/11 to 07/14.
View official government recall

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