Drug product
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400
D-0267-2021
Product summary
- Event
- Event 86998
- Status
- Terminated
- Classification
- Class I
- Quantity
- 280 cartons
- Official record key
drug-enforcement:D-0267-2021
Official wording
Reason: Microbial Contamination of Non-Sterile Product: 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 lot distributed in Zone IV: Lot # 0192894, Exp. 06/30/2023; 9080812 Exp 03/31/2022
Distribution pattern: Distributed in Puerto Rico and Oman
Derived failure modes
-
Microbial contamination
Microbial Contamination