FDA DrugsClass II
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isop...
Published: January 7, 2026Recall ID: D-0243-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterlity
Product Description & Identification
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29
Additional Source Details
| Field | Value |
|---|---|
| City | El Paso |
| State | TX |
| Openfda › Unii › 1 | MOR84MUD8E |
| Openfda › Unii › 2 | ND2M416302 |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui | 1918214 |
| Openfda › Spl id | 41609458-1100-f069-e063-6294a90a6573 |
| Openfda › Brand name | CHLORAPREP SWABSTICK |
| Openfda › Spl set id | 1666069b-38f6-bfde-e063-6394a90ad1b8 |
| Openfda › Package ndc › 1 | 54365-401-28 |
| Openfda › Package ndc › 2 | 54365-401-29 |
| Openfda › Product ndc | 54365-401 |
| 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 | NDA021555 |
| Openfda › Is original packager | true |
| Event id | 98142 |
| Address 1 | 1550 Northwestern Dr |
| Address 2 | N/A |
| Code info | Lot #: 5086623, Exp. Date 03/31/2028 |
| Postal code | 79912-8000 |
| Report date | 20260107 |
| Product type | Drugs |
| Product quantity | 106,400 units |
| Reason for recall | Lack of Assurance of Sterlity |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251217 |
| Initial firm notification | Letter |
| Center classification date | 20251230 |
Overview
- Recalling FirmCareFusion 213, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States