Why it was recalled
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Product description
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.
Lot numbers, UPCs & expiration codes
Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
Where it was sold
Nationwide in the U.S.
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-0441-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 15, 2025
- FDA report date
- May 28, 2025
- Quantity
- 385,200 applicators
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CareFusion 213, LLC
Original FDA data
Every field from FDA enforcement report D-0441-2025, exactly as published.
Show all FDA fields
- City
- El Paso
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 96879
- Address
- 1550 Northwestern Dr
- Code information
- Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
- Postal code
- 79912-8000
- Report date
- May 28, 2025
- Product type
- Drugs
- Recall number
- D-0441-2025
- Classification
- Class II
- Recalling firm
- CareFusion 213, LLC
- Product quantity
- 385,200 applicators
- Reason for recall
- Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- May 15, 2025
- Initial firm notification
- Letter
- Center classification date
- May 20, 2025