FDA DrugsClass II
ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopr...
Published: July 8, 2026Recall ID: D-0646-2026Category: drugsCountry: US
Reason for Recall / Hazard
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 & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | El Paso |
| State | TX |
| Openfda › Unii › 1 | MOR84MUD8E |
| Openfda › Unii › 2 | ND2M416302 |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui › 1 | 858726 |
| Openfda › Rxcui › 2 | 998282 |
| Openfda › Spl id | 42b9d7a7-e6ae-d2ec-e063-6394a90aed91 |
| Openfda › Brand name | CHLORAPREP ONE-STEP |
| Openfda › Spl set id | 8528a4f5-5ff4-45f3-e053-2991aa0a804c |
| Openfda › Package ndc | 54365-400-30 |
| Openfda › Product ndc | 54365-400 |
| Openfda › Generic name | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name › 1 | CHLORHEXIDINE GLUCONATE |
| Openfda › Substance name › 2 | ISOPROPYL ALCOHOL |
| Openfda › Manufacturer name | CareFusion 213, LLC |
| Openfda › Application number | NDA020832 |
| Openfda › Is original packager | true |
| Event id | 99217 |
| Address 1 | 1550 Northwestern Dr |
| Address 2 | N/A |
| Code info | 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 | 20260708 |
| Product type | Drugs |
| 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 |
| Recall initiation date | 20260611 |
| Initial firm notification | Letter |
| Center classification date | 20260629 |
Overview
- Recalling FirmCareFusion 213, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionDistributed Nationwide in the USA