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Class III: unlikely to cause harmTerminated

CareFusion 213 Scrub Care Chlorhexidine Gluconate Solution Recall

Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, V…

CareFusion 213, LLC · El Paso, TX

Risk level
Class III
Reported by FDA
Dec 17, 2014
Recall ID
D-0298-2015
Check your lot numberHow we source this data

Summary

CareFusion 213 recalled Scrub Care Chlorhexidine Gluconate Solution starting Oct 24, 2014. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0298-2015 on Dec 17, 2014. Reason: Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate. Status: Terminated.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

All Lots

Where it was sold

Nationwide; Mexico, Philippines

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0298-2015
Classification
Class III
Status
Terminated
Recall initiated
Oct 24, 2014
FDA report date
Dec 17, 2014
Quantity
20,556,000 scrubs
Recall type
Voluntary: Firm initiated
Recalling firm
CareFusion 213, LLC

Original FDA data

Every field from FDA enforcement report D-0298-2015, exactly as published.

Show all FDA fields
City
El Paso
State
TX
Status
Terminated
Country
United States
Event ID
69605
Address
1550 Northwestern Dr
Code information
All Lots
Postal code
79912-8000
Report date
Dec 17, 2014
Product type
Drugs
Recall number
D-0298-2015
Classification
Class III
Recalling firm
CareFusion 213, LLC
Product quantity
20,556,000 scrubs
Termination date
Oct 8, 2015
Reason for recall
Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Scrub Care Chlorhexidine Gluconate Solution, 4% Surgical Hand Scrub, OTC, CareFusion, Vernon Hills, IL 60061 NDC 57613-007-25
Distribution pattern
Nationwide; Mexico, Philippines
Recall initiation date
Oct 24, 2014
Initial firm notification
Letter
Center classification date
Dec 10, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0298-2015, published Dec 17, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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