ChloraPrep With Tint 2% w/v chlorhexidine gluconate — Class II drug recall D-0350-2021
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-0350-2021 |
|---|---|
| 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 | 7,990,100 cartons |
| Reason classes | microbial contamination, labeling, cgmp, packaging |
| Pathogens | mold |
| Lot numbers | 0009104, 0013602, 0016431, 0022273, 0023788, 0029135, 0032694, 0038211, 0044741, 0064598, 0104862, 0127010, 0196060, 0224915, 8024958, 8025595, 8025597, 8031857, 8033645, 8038971, 8043969, 8043978, 8046513, 8046721, 8053669, 8053699, 8053947, 8055949, 8059513, 8059562, 8061970, 8064854, 8066666, 8068686, 8069986, 8073868, 8087798, 8099735, 8101641, 8106743 and 70 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
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-0350-2021. 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.