FDA Recall D-0268-2021

CareFusion 213, LLC · El Paso, TX

Class I — life-threatening Terminated 814 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, 0.01 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415

Lot / code: All lots including but not limited to the following lots distributed in Zone IV: Lot # 0107872, Exp. 04/30/2023; 0108556, Exp. 04/30/2023; 0148278, Exp. 04/30/2023; 0151978, Exp. 05/31/2023; 0155534, Exp. 05/31/2023; 0157085, Exp. 05/31/2023; 0160618, Exp. 05/31/2023; 0167907, Exp. 05/31/2023.

Quantity: 400 cartons

Reason for recall

Non-sterility: 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.

Recall record

Recall number: D-0268-2021
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed in Puerto Rico and Oman
Recall initiated: 2020-07-07
Classified by FDA Center: 2021-02-19
FDA published: 2021-03-03
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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