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.

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

Code information: a) All lots with expiry between 09/12 to 10/15 and b) All lots with expiry between 10/11 to 07/14.

Distribution pattern: Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom