BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate — Class II drug recall D-0348-2021
Terminated recall by CareFusion 213, LLC, reported 2021-05-05, distributed nationwide. Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Re
| Recall number | D-0348-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 2021-03-19 |
| Classified | 2021-04-26 |
| Reported by FDA | 2021-05-05 |
| Terminated | 2022-09-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BH, BR, CL, HK, KW, OM, QA, SG, ZA |
| Quantity | 14,275,400 cartons |
| Reason classes | microbial contamination, labeling, sterility, packaging |
| Pathogens | mold |
| NDC | 54365-0400, 54365-0400-33 |
| Lot numbers | 0018578, 0058277, 0059141, 0066365, 0067289, 0070866, 0074038, 0076034, 0084619, 0086158, 0090894, 0093903, 0095838, 0097561, 0098470, 0100383, 0109632, 0111185, 0113339, 0115853, 0121982, 0122192, 0122193, 0122194, 0128821, 0129409, 0135287, 0157083, 0161219, 0164032, 0164595, 0168228, 0177338, 0177384, 0178587, 0198836, 0199909, 0204887, 0205674, 0206366 and 42 more |
| Model numbers | 930415 |
Product
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415
Reason for recall
Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, 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-0348-2021. 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.