D-0266-2021 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 3, 2021
- Initiation Date
- July 7, 2020
- Termination Date
- September 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36 cartons
Product Description
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415
Reason for Recall
Microbial Contamination of Non-Sterile Products: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 Pattern
Distributed in Puerto Rico and Oman
Code Information
All lots including but not limited to the following lots distributed in Zone IV: Lot # 0038209, Exp. 01/31/2023; 0098528, Exp. 02/28/2023.