FDA-Drug2013-04-03Class II
SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, Cat. No 260261, NDC 54365-161-01, CareFusion, Leawood, KS 66211; b) 3000-count applicators (Net 0.67 mL each) per case, Cat. No 260431, NDC 54365-151-01, CareFusion, Leawood, KS 66211; and c) 3000-count applicators (Net 0.67 mL each) per case, Reorder TA6200, Manufactured for: Tri-State Hospital Supply Corporation, H
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.
Sold states
Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
Affected count
3,032,000 applicators
Manufactured in
1550 Northwestern Drive, El Paso, TX, United States
Products
SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-count applicators (Net 0.67 mL each) per carton, Cat. No 260261, NDC 54365-161-01, CareFusion, Leawood, KS 66211; b) 3000-count applicators (Net 0.67 mL each) per case, Cat. No 260431, NDC 54365-151-01, CareFusion, Leawood, KS 66211; and c) 3000-count applicators (Net 0.67 mL each) per case, Reorder TA6200, Manufactured for: Tri-State Hospital Supply Corporation, Howell, MI 48843.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-225-2013More CareFusion 213, LLC recalls
- FDA-Drug2026-07-22BD ChloraPrep Clear skin antiseptic recalled for potential sterility packaging defect
- FDA-Drug2026-07-08BD ChloraPrep Hi-Lite Orange recalled for lack of sterility assurance
- FDA-Drug2026-07-08CareFusion ChloraPrep FREPP applicators recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep CLear skin antiseptic recalled for lack of sterility assurance
- FDA-Drug2026-07-08BD ChloraPrep CLear skin antiseptic recalled for lack of sterility assurance
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief