FDAFDA · Food and drugs·Recall number D-229-2013
FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per kit, packaged in 20 kits per carton, Cat. No 260288, NDC 54365-202-99, 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
- All lots with expiry between 07/11 to 08/14.
- 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.