BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate — Class I drug recall D-0268-2021
Terminated recall by CareFusion 213, LLC, reported 2021-03-03, distributed in PR. Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage
| Recall number | D-0268-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 2020-07-07 |
| Classified | 2021-02-19 |
| Reported by FDA | 2021-03-03 |
| Terminated | 2022-09-29 |
| Distributed | PR |
| Countries outside the US | OM |
| Quantity | 400 cartons |
| Reason classes | microbial contamination, labeling, sterility, packaging |
| Pathogens | mold |
| NDC | 54365-0400, 54365-0400-33 |
| Lot numbers | 0107872, 0108556, 0148278, 0151978, 0155534, 0157085, 0160618, 0167907 |
| Model numbers | 930415 |
| Expiration dates | 2023-04-30, 2023-05-31 |
Product
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415
Reason for recall
Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0268-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.