Drug product
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
D-0266-2021
Product summary
- Event
- Event 86998
- Status
- Terminated
- Classification
- Class I
- Quantity
- 36 cartons
- Official record key
drug-enforcement:D-0266-2021
Official wording
Reason: 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.
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.
Distribution pattern: Distributed in Puerto Rico and Oman
Derived failure modes
-
Microbial contamination
Microbial Contamination