Why it was recalled
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Product description
BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.
Lot numbers, UPCs & expiration codes
Lot: 4298581, expires: 09/30/2026.
Where it was sold
Distributed Nationwide in the USA
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-0644-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 11, 2026
- FDA report date
- Jul 8, 2026
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CareFusion 213, LLC
Original FDA data
Every field from FDA enforcement report D-0644-2026, exactly as published.
Show all FDA fields
- City
- El Paso
- State
- TX
- Status
- Ongoing
- Country
- United States
- Event ID
- 99217
- Address
- 1550 Northwestern Dr
- Code information
- Lot: 4298581, expires: 09/30/2026.
- Postal code
- 79912-8000
- Report date
- Jul 8, 2026
- Product type
- Drugs
- Recall number
- D-0644-2026
- Classification
- Class II
- Recalling firm
- CareFusion 213, LLC
- Reason for recall
- Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jun 11, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 29, 2026