ChloraPrep With Tint 2% w/v chlorhexidine gluconate — Class I drug recall D-0346-2021
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 condition
| Recall number | D-0346-2021 |
|---|---|
| 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 | 6,869,400 cartons |
| Reason classes | microbial contamination, labeling, sterility, packaging |
| Pathogens | mold |
| Lot numbers | 0007625, 0007630, 0011737, 0020739, 0023790, 0037278, 0037279, 0038209, 0044734, 0098528, 8095632, 8116723, 8127657, 8135651, 8137527, 8151741, 8158638, 8164530, 8178658, 8193779, 8197517, 8198765, 8212881, 8220737, 8226561, 8235991, 8249940, 8295569, 8304501, 8304849, 8306694, 8311791, 8334983, 8347719, 9008965, 9011841, 9031893, 9037824, 9038599, 9042938 and 48 more |
| Model numbers | 260415 |
Product
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415
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-0346-2021. 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.