SEPP 70% Isopropanol — Class II drug recall D-224-2013
Terminated recall by CareFusion 213, LLC, reported 2013-04-03, distributed nationwide. Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labe
| Recall number | D-224-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 2013-03-04 |
| Classified | 2013-03-28 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2014-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB, MY |
| Quantity | 698,000 applicators |
| Reason classes | labeling, sterility |
| NDC | 54365-0170-01 |
| Model numbers | 260201 |
Product
SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170-01, CareFusion, Leawood, KS 66211.
Reason for recall
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
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-224-2013. 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.