ChlroraPrep One-Step — Class I drug recall D-1511-2020
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-1511-2020 |
|---|---|
| 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 | 4,272,300 applicators |
| Reason classes | sterility |
| Pathogens | mold |
| Lot numbers | 0008777, 0016325, 0021072, 0030959, 0104864, 7235540, 7240735, 7297579, 8003727, 8011688, 8012808, 8087784, 8095620, 8106737, 8130509, 8155991, 8165721, 8187644, 8205560, 8247508, 8289654, 8304783, 8332585, 8337646, 8338794, 9007921, 9015917, 9015920, 9030934, 9045819, 9046572, 9052554, 9059817, 9071761, 9087980, 9087982, 9092575, 9100768, 9101529, 9105675 and 29 more |
| Expiration dates | 2020-08-06, 2020-08-09, 2020-10-08, 2020-11-29, 2021-03-31, 2021-04-30, 2021-05-31, 2021-06-30, 2021-07-31, 2021-08-31, 2021-09-30, 2021-10-31, 2021-11-30, 2021-12-31, 2022-01-31, 2022-02-28, 2022-03-31, 2022-04-30, 2022-05-31, 2022-06-30, 2022-07-31, 2022-08-31, 2022-09-30, 2022-10-31, 2022-11-30 and 3 more |
Product
ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01
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-1511-2020. 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.