Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol Recalled by CareFusion 213, LLC Due to Labeling: Not Elsewhere Classified: This product is misbranded...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CareFusion 213, LLC directly.
Affected 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.
Quantity: 3,032,000 applicators
Why Was This Recalled?
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CareFusion 213, LLC
CareFusion 213, LLC has 29 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report