FDA Drug recall D-1674-2012
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 2604…
- FDA Drug
- Class II
- terminated
- Published 2012-09-26
On 2012-09-26 the FDA classified a Class II recall of ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 2604… by Carefusion 213, citing lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1674-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-11-08 |
| Published | 2012-09-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Carefusion 213 |
| Distribution | US |
Product
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
Reason
Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Identifiers
| code_info | Product code 260415, Lot#: 48225 |
|---|
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-1674-2012%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.