Drug product
Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged in 20-count kits per carton, Cat. No 260311, NDC 54365-201-99, CareFusion, Leawood, KS 66211.
D-228-2013
Product summary
- Event
- Event 64583
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46,500 kits
- Official record key
drug-enforcement:D-228-2013
Official wording
Reason: Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Code information: All lots with expiry between 09/11 to 09/13.
Distribution pattern: Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
Derived failure modes
-
Labeling or packaging
misbranded