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
ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB
Lot numbers, UPCs & expiration codes
Lot: 3279063, Exp. 9/30/2026, 3319524, 3324094, 3343541, Exp. 11/30/2026, 3357638, 4010202,Exp. 12/31/2026, 4206771, Exp. 7/31/2027, 4267824, 4270191, 4282285, Exp.9/30/2027, 4338352, Exp. 11/30/2027, 5053657, Exp. 2/29/2028, 5121340, Exp. 4/30/2028.
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-0646-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 11, 2026
- FDA report date
- Jul 8, 2026
- Quantity
- 10,500 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- CareFusion 213, LLC
Original FDA data
Every field from FDA enforcement report D-0646-2026, 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: 3279063, Exp. 9/30/2026, 3319524, 3324094, 3343541, Exp. 11/30/2026, 3357638, 4010202,Exp. 12/31/2026, 4206771, Exp. 7/31/2027, 4267824, 4270191, 4282285, Exp.9/30/2027, 4338352, Exp. 11/30/2027, 5053657, Exp. 2/29/2028, 5121340, Exp. 4/30/2028.
- Postal code
- 79912-8000
- Report date
- Jul 8, 2026
- Product type
- Drugs
- Recall number
- D-0646-2026
- Classification
- Class II
- Recalling firm
- CareFusion 213, LLC
- Product quantity
- 10,500 units
- 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
- ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365-400-30, Catalog number 930599NSB
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jun 11, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 29, 2026