Why it was recalled
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Product description
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.
Lot numbers, UPCs & expiration codes
Lot #: 3200240, Exp 6/30/2026
Where it was sold
Nationwide and Canada
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-0259-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Feb 14, 2025
- FDA report date
- Mar 19, 2025
- Quantity
- 205,440 applicators
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CareFusion 213, LLC
Original FDA data
Every field from FDA enforcement report D-0259-2025, exactly as published.
Show all FDA fields
- City
- El Paso
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 96262
- Address
- 1550 Northwestern Dr
- Code information
- Lot #: 3200240, Exp 6/30/2026
- Postal code
- 79912-8000
- Report date
- Mar 19, 2025
- Product type
- Drugs
- Recall number
- D-0259-2025
- Classification
- Class I
- Recalling firm
- CareFusion 213, LLC
- Product quantity
- 205,440 applicators
- Reason for recall
- Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.
- Distribution pattern
- Nationwide and Canada
- Recall initiation date
- Feb 14, 2025
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 7, 2025