Recalls / Class III
Class IIID-0298-2015
Product
Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC 57613-007-25
- Affected lot / code info
- All Lots
Why it was recalled
Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.
Recalling firm
- Firm
- CareFusion 213, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1550 Northwestern Dr, N/A, El Paso, Texas 79912-8000
Distribution
- Quantity
- 20,556,000 scrubs
- Distribution pattern
- Nationwide; Mexico, Philippines
Timeline
- Recall initiated
- 2014-10-24
- FDA classified
- 2014-12-10
- Posted by FDA
- 2014-12-17
- Terminated
- 2015-10-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0298-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.