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Recall Observatory FDA recall evidence

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

July 07, 2020

Class I

Product summary

Firm
CareFusion 213, LLC
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

    reason.microbial_contamination · v1.0.0

    Microbial Contamination