FDA Recall D-0265-2021

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 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, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400

Lot / code: All lots including but not limited to the following lots distributed in Zone IV: Lot # 0161217 Exp. 05/31/2023; 0211068 Exp. 07/31/2023; 0176660 Exp. 06/30/2023; 0188805 Exp. 06/30/2023; 0175874 Exp. 06/30/2023; 0151977 Exp. 05/31/2023; 0149328 Exp. 04/30/2023; 0085419 Exp. 03/31/2023

Quantity: 988 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-0265-2021
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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