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, applicator is sterile if package is intact. CareFusion 213, LLC, 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.
CareFusion 213, LLC is recalling BD ChloraPrep Clear, a sterile skin preparation solution containing 2% chlorhexidine gluconate and 70% isopropyl alcohol in 3 ml applicators (25 applicators per carton). The recall affects 952,100 cartons 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 product is being recalled due to non-sterility concerns, specifically because fungal growth (Aspergillus penicillioides) was found to breach package integrity when stored at the labeled storage conditions of 30°C and 75% relative humidity.
The affected lots are identified by their lot numbers and expiration dates: 0065386 (2/28/2023), 0085419 (3/31/2023), 0091666 (3/31/2023), 0149328 (4/30/2023), 0151977 (5/31/2023), 0161217 (5/31/2023), 0175874 (6/30/2023), 0176660 (6/30/2023), 0188805 (6/30/2023), and 0211068 (7/31/2023). The recall record does not specify a remedy or instructions for what affected consumers should do.
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: 952,100 cartons Lot/code info: Lot and Exp Date: 0065386, 2/28/2023; 0085419, 3/31/2023; 0091666, 3/31/2023; 0149328, 4/30/2023; 0151977, 5/31/2023; 0161217, 5/31/2023; 0175874, 6/30/2023; 0176660, 6/30/2023; 0188805, 6/30/2023; 0211068, 7/31/2023;
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.