Drug 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
D-0348-2021
Product summary
- Event
- Event 87592
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,275,400 cartons
- Official record key
drug-enforcement:D-0348-2021
Official wording
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.
Code information: 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, 8/31/2023; 0255091, 8/31/2023; 0259156, 9/30/2023; 0263754, 9/30/2023; 0267575, 9/30/2023; 0272405, 9/30/2023; 0300187, 10/31/2023; 0304315, 10/31/2023; 0305488, 10/31/2023; 0306841, 10/31/2023; 0307140, 9/30/2023; 0312694, 10/31/2023; 0313824, 10/31/2023; 0319649, 11/30/2023; 0324409, 11/30/2023; 0325577, 11/30/2023; 0326746, 11/30/2023; 0330938, 11/30/2023; 0335971, 11/30/2023; 0340937, 11/30/2023; 0347570, 12/31/2023; 0347571, 12/31/2023; 0355671, 12/31/2023; 0356362, 12/31/2023; 1008758, 12/31/2023; 1009747, 12/31/2023; 1028187, 1/31/2024; 1033578, 1/31/2024; 1034948, 1/31/2024; 1035662, 1/31/2024; 1036544, 1/31/2024; 1055547, 2/29/2024; 1060432, 2/29/2024; 9324226, 10/31/2022; 9343836, 11/30/2022; 9344810, 10/31/2022;
Distribution pattern: Distributed Nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, Brazil.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility