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