FDA Recall D-0344-2021

CareFusion 213, LLC · El Paso, TX

Class I — life-threatening Terminated 559 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

BD ChloraPrep Hi-Lite Orange 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 El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415

Lot / code: Lot and Exp Date: 0107872, 4/30/2023; 0108556, 4/30/2023; 0148278, 4/30/2023; 0151978, 5/31/2023; 0155534, 5/31/2023; 0157085, 5/31/2023; 0160618, 5/31/2023; 0167907, 5/31/2023;

Quantity: 1,434,000 cartons

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.

Recall record

Recall number: D-0344-2021
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Press Release
Distribution: 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.
Recall initiated: 2021-03-19
Classified by FDA Center: 2021-04-26
FDA published: 2021-05-05
Terminated: 2022-09-29
Recalling firm: CareFusion 213, LLC
Firm location: El Paso, TX

Drug identification

Brand name(s): CHLORAPREP ONE-STEP
Generic name(s): CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL
Manufacturer(s): CareFusion 213, LLC
NDC(s): 54365-400
Route(s): TOPICAL

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