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 54365-40
Check against the official notice below — it lists the full affected range.
BD ChloraPrep Hi-Lite Orange 2% chlorhexidine gluconate and 70% isopropyl alcohol sterile solution in 3 ml applicators (25 applicators per carton) is being recalled due to non-sterility. When stored at the labeled conditions of 30°C and 75% relative humidity, fungal growth of Aspergillus penicillioides caused the package integrity to fail. Approximately 1.4 million cartons were distributed nationwide in the USA and internationally to Singapore, Chile, Oman, Colombia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, and Brazil.
The affected products include eight specific lot numbers with expiration dates ranging from April 30, 2023 to May 31, 2023. The source does not specify a remedy or instructions for what consumers should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Reason for recall: Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity. Distribution: 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. Quantity: 1,434,000 cartons Lot/code info: Lot and Exp Date: 0107872, 4/30/2023; 0108556, 4/30/2023; 0148278, 4/30/2023; 0151978, 5/31/2023; 0155534, 5/31/2023; 0157085, 5/31/2023; 0160618, 5/31/2023; 0167907, 5/31/2023;
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.