ChloraPrep OneStep — Class II drug recall D-0029-2018
Terminated recall by Becton Dickinson & Company, reported 2017-11-01, distributed in IL, MO, PA, TN, VA. Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, th
| Recall number | D-0029-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Company, Franklin Lakes, NJ, United States |
| Recall initiated | 2017-09-15 |
| Classified | 2017-10-23 |
| Reported by FDA | 2017-11-01 |
| Terminated | 2018-06-27 |
| Distributed | IL, MO, PA, TN, VA |
| Quantity | 628,000 applicators |
| Reason classes | labeling |
| Lot numbers | 7096622 |
| Expiration dates | 2020-03-21 |
Product
ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11
Reason for recall
Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear), however, the correct label should be Chloroprep with Tint (Hi Lite Orange)
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-0029-2018. 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.