FDAFDA · Food and drugs·Recall number D-0268-2021
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
Published March 3, 2021 · Recall initiated: July 7, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CHLORAPREP ONE-STEP
- Manufacturer
- CareFusion 213, LLC
- Distributor
- Distributed in Puerto Rico and Oman
- Lot
- 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.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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