ChloraPrep One-Step 2% w/v chlorhexidine gluconate — Class I drug recall D-0345-2021
Terminated recall by CareFusion 213, LLC, reported 2021-05-05, distributed nationwide. Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions
| Recall number | D-0345-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 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 | 11,115,774 cartons |
| Reason classes | microbial contamination, labeling, sterility, packaging |
| Pathogens | mold |
| Lot numbers | 0008777, 0016325, 0021072, 0027041, 0030959, 0031090, 0044735, 0048062, 0052110, 0056365, 0086148, 0104864, 0192894, 8081571, 8086851, 8087784, 8095620, 8106737, 8107819, 8124917, 8130509, 8131816, 8135646, 8141808, 8149992, 8155991, 8162912, 8163900, 8165721, 8176743, 8187644, 8194993, 8199884, 8201565, 8205560, 8206895, 8207995, 8221939, 8228634, 8235981 and 89 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
Microbial Contamination of Non-Sterile Product.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted 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-0345-2021. 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.