FDA DrugsClass I
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl ...
Published: July 1, 2026Recall ID: D-0624-2026Category: drugsCountry: US
Reason for Recall / Hazard
Non-Sterility: Due to presence of Aspergillus penicillioides.
Product Description & Identification
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.
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 | 42c769de-f1e0-b3a1-e063-6394a90ab2a1 |
| Openfda › Brand name | CHLORAPREP ONE-STEP |
| Openfda › Spl set id | 85291b2b-40b9-07fa-e053-2a91aa0a84e4 |
| Openfda › Package ndc | 54365-400-31 |
| 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 | 99114 |
| Address 1 | 1550 Northwestern Dr |
| Address 2 | N/A |
| Code info | Lot # 4032183, Exp 01/31/2027 |
| Postal code | 79912-8000 |
| Report date | 20260701 |
| Product type | Drugs |
| Product quantity | 193,440 applicators |
| Reason for recall | Non-Sterility: Due to presence of Aspergillus penicillioides. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260528 |
| Initial firm notification | Letter |
| Center classification date | 20260625 |
Overview
- Recalling FirmCareFusion 213, LLC
- StatusOngoing
- Risk LevelClass I
- DistributionNationwide inthe USA, as well as other foreign distribution.