FDA DrugsClass I
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isop...
Published: July 1, 2026Recall ID: D-0625-2026Category: drugsCountry: US
Reason for Recall / Hazard
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Product Description & Identification
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.
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 | 99114 |
| Address 1 | 1550 Northwestern Dr |
| Address 2 | N/A |
| Code info | Lot # 4073005, Exp 03/31/2027 |
| Postal code | 79912-8000 |
| Report date | 20260701 |
| Product type | Drugs |
| Product quantity | 178,000 applicators |
| Reason for recall | Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. |
| 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.