D-1510-2020 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 26, 2020
- Initiation Date
- June 23, 2020
- Termination Date
- September 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,800,800 applicators
Product Description
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11
Reason for Recall
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Distribution Pattern
Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,
Code Information
Lot #: 7194739, Exp. 06/25/2020; 7214841, Exp. Date 07/17/2020; 7213558, Exp. Date 07/16/2020; 7227839, Exp. Date 07/30/2020; 7276589, Exp. Date 09/20/2020; 7198824, Exp. Date 06/29/2020; 7275718, Exp. Date 09/19/2020; 7289776, Exp. Date 09/30/2020; 7306916, Exp. Date 10/12/2020; 8011665, Exp. Date 12/14/2020; 8015801, Exp. Date 12/18/2020; 8031857, Exp. Date 01/31/2021; 8033645, Exp. Date 01/31/2021; 8127657, Exp. Date 04/30/2021; 8137527, 8157141, 8158638, Exp. Date 05/31/2021; 8164530, Exp. Date 06/30/2021; 8220737, Exp. Date 07/31/2021; 8235991, Exp. Date 08/31/2021; 8043978, Exp. Date 01/31/2021; 8306694, Exp. Date 10/31/2021; 8334983, Exp. Date 11/30/2021; 9031893, 9038599, 9042938, Exp. Date 01/31/2022; 9051563, 9053560, 9072856, Exp. Date 02/28/2022; 9086532, Exp. Date 03/31/2022; 9137904, Exp. Date 05/31/2022; 9087985, Exp. Date 03/31/2022; 9191256, 9168975, Exp. Date 06/30/2022; 9218464, 9218595, Exp. Date 07/31/2022; 9228305, 9241932, 9247742, 9249471, Exp. Date 08/31/2022; 9269603, Exp. Date 09/30/2022; 9296395, 9295914, 9311076, Exp. Date 10/31/2022; 9316348, 9324565, 9345911, Exp. Date 11/30/2022; 9305775, Exp. Date 10/31/2022; 0011737, Exp. Date 12/31/2022; 0023790, 0037279, Exp. Date 01/31/2023.