D-0343-2021 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 5, 2021
- Initiation Date
- March 19, 2021
- Termination Date
- September 29, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 952,100 cartons
Product Description
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400
Reason for Recall
Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Distribution Pattern
Distributed Nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, Brazil.
Code Information
Lot and Exp Date: 0065386, 2/28/2023; 0085419, 3/31/2023; 0091666, 3/31/2023; 0149328, 4/30/2023; 0151977, 5/31/2023; 0161217, 5/31/2023; 0175874, 6/30/2023; 0176660, 6/30/2023; 0188805, 6/30/2023; 0211068, 7/31/2023;