ChloraPrep One-Step 2% w/v chlorhexidine gluconate — Class II drug recall D-0349-2021
Terminated recall by CareFusion 213, LLC, reported 2021-05-05, distributed nationwide. CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity
| Recall number | D-0349-2021 |
|---|---|
| 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 | 40,720,900 cartons |
| Reason classes | microbial contamination, labeling, cgmp, packaging |
| Pathogens | mold |
| Lot numbers | 0000192, 0007621, 0008775, 0009111, 0011738, 0011753, 0011754, 0011755, 0013604, 0015498, 0015500, 0016329, 0017929, 0021945, 0028887, 0031093, 0034660, 0035149, 0036460, 0037272, 0038213, 0038217, 0041893, 0042483, 0042501, 0043105, 0044739, 0094838, 0098051, 0104859, 0129330, 0133069, 0220728, 0223036, 8078998, 8079620, 8079621, 8082921, 8082923, 8085804 and 381 more |
| Model numbers | 260400 |
Product
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400
Reason for recall
CGMP Deviations: 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-0349-2021. 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.