ChloraPrep One-Step — Class II drug recall D-004-2013
Terminated recall by Carefusion 213, Llc, reported 2012-10-10, distributed in IL, MO, NJ. Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed ster
| Recall number | D-004-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefusion 213, Llc, El Paso, TX, United States |
| Recall initiated | 2012-04-23 |
| Classified | 2012-10-03 |
| Reported by FDA | 2012-10-10 |
| Terminated | 2013-09-11 |
| Distributed | IL, MO, NJ |
| Quantity | 576 cartons |
| Reason classes | sterility |
| NDC | 54365-0400-01 |
| Lot numbers | 52894 |
Product
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.
Reason for recall
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
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-004-2013. 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.