FDA Drug recall D-0348-2021

BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml…

FDA Drug
Class II
terminated
Published 2021-05-05

On 2021-05-05 the FDA classified a Class II recall of BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml… by Carefusion 213, citing lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus pen….

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0348-2021
Classification	Class II
Status	terminated
Initiated	2021-03-19
Published	2021-05-05
Last updated	2026-09-13 11:52 UTC
Company	Carefusion 213
Distribution	US

Product

BD ChloraPrep Hi-Lite Orange 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, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415

Reason

Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

Identifiers

ndc	54365-400-33
code_info	Lot and Exp Date: 0018578, 11/30/2022; 0058277, 2/28/2023; 0059141, 2/28/2023; 0066365, 2/28/2023; 0067289, 3/31/2… Lot and Exp Date: 0018578, 11/30/2022; 0058277, 2/28/2023; 0059141, 2/28/2023; 0066365, 2/28/2023; 0067289, 3/31/2023; 0070866, 3/31/2023; 0074038, 3/31/2023; 0076034, 3/31/2023; 0084619, 3/31/2023; 0086158, 3/31/2023; 0090894, 3/31/2023; 0093903, 3/31/2023; 0095838, 3/31/2023; 0097561, 3/31/2023; 0098470, 3/31/2023; 0100383, 2/28/2023; 0109632, 4/30/2023; 0111185, 4/30/2023; 0113339, 4/30/2023; 0115853, 4/30/2023; 0121982, 4/30/2023; 0122192, 4/30/2023; 0122193, 4/30/2023; 0122194, 4/30/2023; 0128821, 4/30/2023; 0129409, 4/30/2023; 0135287, 4/30/2023; 0157083, 5/31/2023; 0161219, 5/31/2023; 0164032, 6/30/2023; 0164595, 5/31/2023; 0168228, 6/30/2023; 0177338, 6/30/2023; 0177384, 6/30/2023; 0178587, 6/30/2023; 0198836, 7/31/2023; 0199909, 6/30/2023; 0204887, 7/31/2023; 0205674, 6/30/2023; 0206366, 7/31/2023; 0207651, 7/31/2023; 0210578, 7/31/2023; 0227493, 7/31/2023; 0241043, 8/31/2023; 0249695, 8/31/2023; 0252883, 8/31/2023; 0254864, 8/31/

ndc

54365-400-33

code_info

Lot and Exp Date: 0018578, 11/30/2022; 0058277, 2/28/2023; 0059141, 2/28/2023; 0066365, 2/28/2023; 0067289, 3/31/2…

Lot and Exp Date: 0018578, 11/30/2022; 0058277, 2/28/2023; 0059141, 2/28/2023; 0066365, 2/28/2023; 0067289, 3/31/2023; 0070866, 3/31/2023; 0074038, 3/31/2023; 0076034, 3/31/2023; 0084619, 3/31/2023; 0086158, 3/31/2023; 0090894, 3/31/2023; 0093903, 3/31/2023; 0095838, 3/31/2023; 0097561, 3/31/2023; 0098470, 3/31/2023; 0100383, 2/28/2023; 0109632, 4/30/2023; 0111185, 4/30/2023; 0113339, 4/30/2023; 0115853, 4/30/2023; 0121982, 4/30/2023; 0122192, 4/30/2023; 0122193, 4/30/2023; 0122194, 4/30/2023; 0128821, 4/30/2023; 0129409, 4/30/2023; 0135287, 4/30/2023; 0157083, 5/31/2023; 0161219, 5/31/2023; 0164032, 6/30/2023; 0164595, 5/31/2023; 0168228, 6/30/2023; 0177338, 6/30/2023; 0177384, 6/30/2023; 0178587, 6/30/2023; 0198836, 7/31/2023; 0199909, 6/30/2023; 0204887, 7/31/2023; 0205674, 6/30/2023; 0206366, 7/31/2023; 0207651, 7/31/2023; 0210578, 7/31/2023; 0227493, 7/31/2023; 0241043, 8/31/2023; 0249695, 8/31/2023; 0252883, 8/31/2023; 0254864, 8/31/

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-0348-2021%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.