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Recall Observatory FDA recall evidence

Drug product

Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC 57613-007-25

D-0298-2015

October 24, 2014

Class III

Product summary

Firm
CareFusion 213, LLC
Event
Event 69605
Status
Terminated
Classification
Class III
Quantity
20,556,000 scrubs
Official record key
drug-enforcement:D-0298-2015

Official wording

Reason: Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.

Code information: All Lots

Distribution pattern: Nationwide; Mexico, Philippines

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.