CareFusion 213, LLC recalls SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count a
Recalled April 3, 2013 · FDA recall D-226-2013 · CareFusion 213
Hazard
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims. · FDA Class II
Units
8,960,000 applicators
Sold at
Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
Description
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
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.
Manufacturer(s)
CareFusion 213, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →