BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415
Check against the official notice below — it lists the full affected range.
CareFusion 213, LLC is recalling BD ChloraPrep Hi-Lite Orange 2% chlorhexidine gluconate and 70% isopropyl alcohol sterile solution applicators distributed in Puerto Rico and Oman. The recall affects 400 cartons due to a non-sterility issue: when stored at the labeled conditions of 30°C and 75% relative humidity for more than 6 months, the product may allow growth of Aspergillus penicillioides, a fungus that can compromise package integrity.
The recall includes all lots distributed in Zone IV climatic regions, with specific lots identified including lot numbers 0107872, 0108556, 0148278, 0151978, 0155534, 0157085, 0160618, and 0167907, with expiration dates ranging from April 2023 to May 2023. The recall notice does not specify what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Distributed in Puerto Rico and Oman Quantity: 400 cartons Lot/code info: All lots including but not limited to the following lots distributed in Zone IV: Lot # 0107872, Exp. 04/30/2023; 0108556, Exp. 04/30/2023; 0148278, Exp. 04/30/2023; 0151978, Exp. 05/31/2023; 0155534, Exp. 05/31/2023; 0157085, Exp. 05/31/2023; 0160618, Exp. 05/31/2023; 0167907, Exp. 05/31/2023.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.