CareFusion 213, LLC: BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El

Is my product affected?

BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32

• Brand CHLORAPREP ONE-STEP

Check against the official notice below — it lists the full affected range.

What happened

BD ChloraPrep Clear 3 mL Applicators containing 2% chlorhexidine gluconate and 70% isopropyl alcohol are being recalled because the product is not sterile due to the presence of Aspergillus Penicilloides. The affected product consists of 12,500 applicators in two specific lots: Lot #0065386 (expiration 2/28/2023) and Lot #0091666 (expiration 3/31/2023). The product was distributed to Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, and Singapore.

The recall source does not specify a remedy or instructions for what affected consumers should do regarding this recalled product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides

Details from the source

Reason for recall: Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides Distribution: 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, Quantity: 12,500 applicators Lot/code info: Lot #: 0065386 Exp. 2/28/2023; 0091666 Exp. 3/31/2023

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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