FDA Drug recall D-0265-2021
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 2…
- FDA Drug
- Class I
- terminated
- Published 2021-03-03
On 2021-03-03 the FDA classified a Class I recall of BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 2… by Carefusion 213, citing non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, the….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0265-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-07-07 |
| Published | 2021-03-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Carefusion 213 |
| Distribution | PR |
Product
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400
Reason
Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Identifiers
| ndc | 54365-400-32 |
|---|---|
| code_info | All lots including but not limited to the following lots distributed in Zone IV: Lot # 0161217 Exp. 05/31/2023; 021106…All lots including but not limited to the following lots distributed in Zone IV: Lot # 0161217 Exp. 05/31/2023; 0211068 Exp. 07/31/2023; 0176660 Exp. 06/30/2023; 0188805 Exp. 06/30/2023; 0175874 Exp. 06/30/2023; 0151977 Exp. 05/31/2023; 0149328 Exp. 04/30/2023; 0085419 Exp. 03/31/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0265-2021%22
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