ChloraPrep With Tint — Class I drug recall D-1510-2020
Terminated recall by CareFusion 213, LLC, reported 2020-08-26, distributed in GU, PR. Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
| Recall number | D-1510-2020 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 213, LLC, El Paso, TX, United States |
| Recall initiated | 2020-06-23 |
| Classified | 2020-08-19 |
| Reported by FDA | 2020-08-26 |
| Terminated | 2022-09-28 |
| Distributed | GU, PR |
| Countries outside the US | AE, BH, BR, CL, CO, GB, HK, IE, IL, KW, OM, QA, SA, SG |
| Quantity | 2,800,800 applicators |
| Reason classes | sterility |
| Pathogens | mold |
| Lot numbers | 0011737, 0023790, 0037279, 7194739, 7198824, 7213558, 7214841, 7227839, 7275718, 7276589, 7289776, 7306916, 8011665, 8015801, 8031857, 8033645, 8043978, 8127657, 8137527, 8157141, 8158638, 8164530, 8220737, 8235991, 8306694, 8334983, 9031893, 9038599, 9042938, 9051563, 9053560, 9072856, 9086532, 9087985, 9137904, 9168975, 9191256, 9218464, 9218595, 9228305 and 11 more |
| Expiration dates | 2020-06-25, 2020-06-29, 2020-07-16, 2020-07-17, 2020-07-30, 2020-09-19, 2020-09-20, 2020-09-30, 2020-10-12, 2020-12-14, 2020-12-18, 2021-01-31, 2021-04-30, 2021-05-31, 2021-06-30, 2021-07-31, 2021-08-31, 2021-10-31, 2021-11-30, 2022-01-31, 2022-02-28, 2022-03-31, 2022-05-31, 2022-06-30, 2022-07-31 and 6 more |
Product
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11
Reason for recall
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
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-1510-2020. 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.