ChloraPrep with Tint — Class II drug recall D-1674-2012
Terminated recall by Carefusion 213, Llc, reported 2012-09-26, distributed nationwide. Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on
| Recall number | D-1674-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefusion 213, Llc, El Paso, TX, United States |
| Recall initiated | 2011-11-08 |
| Classified | 2012-09-17 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2013-05-23 |
| Distributed | Nationwide (US) |
| Quantity | 67,775 applicators |
| Reason classes | sterility |
| Lot numbers | 48225 |
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 for recall
Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
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-1674-2012. 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.