FDAFDA · Food and drugs·Recall number D-224-2013
SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170-01, 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 distributed between 01/10 to 02/13
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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