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, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400
Check against the official notice below — it lists the full affected range.
BD ChloraPrep Clear is a sterile antiseptic solution containing chlorhexidine gluconate and isopropyl alcohol used for skin preparation before medical procedures. CareFusion 213, LLC is recalling the product distributed to Puerto Rico and Oman because when stored at the labeled conditions of 30°C (86°F) and 75% relative humidity for more than six months, there is potential for growth of Aspergillus penicillioides fungus, which can compromise the sterility and package integrity of the product. A total of 988 cartons are affected, representing multiple lot numbers with expiration dates ranging from March 2023 through July 2023.
The recall notice does not specify a remedy or recommended action for consumers who may have affected product.
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: 988 cartons Lot/code info: All lots including but not limited to the following lots distributed in Zone IV: Lot # 0161217 Exp. 05/31/2023; 0211068 Exp. 07/31/2023; 0176660 Exp. 06/30/2023; 0188805 Exp. 06/30/2023; 0175874 Exp. 06/30/2023; 0151977 Exp. 05/31/2023; 0149328 Exp. 04/30/2023; 0085419 Exp. 03/31/2023
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.