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Recall Observatory FDA recall evidence

Drug product

CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-013-15.

D-1360-2014

December 20, 2013

Class II

Product summary

Firm
Carefusion 2200 Inc
Event
Event 68176
Status
Terminated
Classification
Class II
Quantity
1,662,000 Surgical Scrub Brushes
Official record key
drug-enforcement:D-1360-2014

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: 4452B

Distribution pattern: Nationwide and Puerto Rico; Bahrain, Germany, Mexico, Philippines

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent