FDAFDA · Food and drugs·Recall number D-226-2013
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.
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 09/12 to 10/15 and b) All lots with expiry between 10/11 to 07/14.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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