FDA Drug recall D-1510-2020
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applic…
- FDA Drug
- Class I
- terminated
- Published 2020-08-26
On 2020-08-26 the FDA classified a Class I recall of ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applic… by Carefusion 213, citing non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1510-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-06-23 |
| Published | 2020-08-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Carefusion 213 |
| Distribution | PR |
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
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Identifiers
| code_info | Lot #: 7194739, Exp. 06/25/2020; 7214841, Exp. Date 07/17/2020; 7213558, Exp. Date 07/16/2020; 7227839, Exp. Date 07/30…Lot #: 7194739, Exp. 06/25/2020; 7214841, Exp. Date 07/17/2020; 7213558, Exp. Date 07/16/2020; 7227839, Exp. Date 07/30/2020; 7276589, Exp. Date 09/20/2020; 7198824, Exp. Date 06/29/2020; 7275718, Exp. Date 09/19/2020; 7289776, Exp. Date 09/30/2020; 7306916, Exp. Date 10/12/2020; 8011665, Exp. Date 12/14/2020; 8015801, Exp. Date 12/18/2020; 8031857, Exp. Date 01/31/2021; 8033645, Exp. Date 01/31/2021; 8127657, Exp. Date 04/30/2021; 8137527, 8157141, 8158638, Exp. Date 05/31/2021; 8164530, Exp. Date 06/30/2021; 8220737, Exp. Date 07/31/2021; 8235991, Exp. Date 08/31/2021; 8043978, Exp. Date 01/31/2021; 8306694, Exp. Date 10/31/2021; 8334983, Exp. Date 11/30/2021; 9031893, 9038599, 9042938, Exp. Date 01/31/2022; 9051563, 9053560, 9072856, Exp. Date 02/28/2022; 9086532, Exp. Date 03/31/2022; 9137904, Exp. Date 05/31/2022; 9087985, Exp. Date 03/31/2022; 9191256, 9168975, Exp. Date 06/30/2022; 9218464, 9218595, Exp. Date 07/31/2022; 9228305, 9241932, 9247742, 9249471, Exp. Date 08/31/2022; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Carefusion 213
- BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) e…
FDA Drug · Class II · 2026-07-22 · Carefusion 213 - BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/cas…
FDA Drug · Class II · 2026-07-08 · Carefusion 213 - BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUT…
FDA Drug · Class II · 2026-07-08 · Carefusion 213 - BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, Ca…
FDA Drug · Class II · 2026-07-08 · Carefusion 213 - BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION,…
FDA Drug · Class II · 2026-07-08 · Carefusion 213
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1510-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.