Drug product
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-003-18
D-1359-2014
Product summary
- Event
- Event 68176
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,443,500 scrub brushes
- Official record key
drug-enforcement:D-1359-2014
Official wording
Reason: Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.
Code information: 4451B; 4451GL
Distribution pattern: Nationwide and Puerto Rico; Bahrain, Germany, Mexico, Philippines
Derived failure modes
-
Potency or specification failure
Subpotent