FDA Drug recall D-0259-2025
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Pr…
- FDA Drug
- Class I
- ongoing
- Published 2025-03-19
On 2025-03-19 the FDA classified a Class I recall of BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Pr… by Carefusion 213, citing non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0259-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-02-14 |
| Published | 2025-03-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Carefusion 213 |
| Distribution | US |
Product
BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, 0.03 fl. oz (1 mL) each, 60 Applicators per Carton, CareFusion 213, LLC, El Paso, TX 79912, Subsidiary of Becton, Dickinson and Co., REF 930480, NDC 54365-400-31.
Reason
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Identifiers
| ndc | 54365-400-31 |
|---|---|
| code_info | Lot #: 3200240, Exp 6/30/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0259-2025%22
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