ChloraPrep With Tint — Class II drug recall D-1442-2014
Terminated recall by CareFusion 213, LLC, reported 2014-07-23, distributed nationwide. Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
| Recall number | D-1442-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 2013-06-13 |
| Classified | 2014-07-17 |
| Reported by FDA | 2014-07-23 |
| Terminated | 2015-04-22 |
| Distributed | Nationwide (US) |
| Quantity | 23,000 applicators |
| Reason classes | sterility |
| Lot numbers | 71132 |
| Expiration dates | 2017-02 |
Product
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.
Reason for recall
Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
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-1442-2014. 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.