Drug product
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.
D-224-2013
Product summary
- Event
- Event 64583
- Status
- Terminated
- Classification
- Class II
- Quantity
- 698,000 applicators
- Official record key
drug-enforcement:D-224-2013
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 distributed between 01/10 to 02/13
Distribution pattern: Nationwide, Puerto Rico, Virgin Islands, Malaysia, and United Kingdom
Derived failure modes
-
Labeling or packaging
misbranded