FDA Drug recall D-004-2013
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators,…
- FDA Drug
- Class II
- terminated
- Published 2012-10-10
On 2012-10-10 the FDA classified a Class II recall of ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators,… by Carefusion 213, citing lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-004-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-04-23 |
| Published | 2012-10-10 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Carefusion 213 |
| Distribution | IL, MO, NJ |
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
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Identifiers
| code_info | Lot 52894, Product Code: 260400 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-004-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.