FDAFDA · Food and drugs·Recall number D-225-2013
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.
Published April 3, 2013 · Recall initiated: March 4, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CareFusion 213, LLC
- Distributor
- Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
- Lot
- a) All lots with expiry between 02/12 to 10/15; b) All lots with expiry between 09/11 to 12/13; and c) All lots with expiry between 12/11 to 12/11.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.