The Recall Desk

FDA (Drugs) recall action 87592

CareFusion 213, LLC recalled 8 products on 2021-05-05

The FDA (Drugs) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products
8
Announced
2021-05-05
Critical
2
Units
108,327,374

Why these products were recalled

CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

Microbial Contamination of Non-Sterile Product:.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.

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

  • HighFDA (Drugs)··2021-05-05

    CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Growth Risk

    CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators because fungal growth may breach package integrity. The product was distributed in the US and 12 other countries.

    Product
    ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 26040
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2021-05-05

    CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Growth Risk

    CareFusion 213, LLC is recalling ChloraPrep With Tint antiseptic applicators because fungal growth may breach package integrity at labeled storage conditions.

    Product
    ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-05-05

    CareFusion Recalls ChloraPrep Antiseptic Due to Fungal Contamination

    CareFusion is recalling ChloraPrep antiseptic applicators because fungal growth breached package integrity. The product is non-sterile, but the breach compromises the sterility of the applicators.

    Product
    ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2021-05-05

    FDA Recalls Chloraprep One-Step Antiseptic Due to Fungal Contamination

    CareFusion 213, LLC is recalling Chloraprep One-Step antiseptic applicators because fungal growth breached package integrity. The product is distributed nationwide and internationally.

    Product
    CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2021-05-05

    ChloraPrep One-Step Recalled for Fungal Contamination and Package Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators because fungal growth breached package integrity. The product is a sterile skin antiseptic.

    Product
    CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-05-05

    CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Contamination

    CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators because fungal growth breached package integrity under labeled storage conditions.

    Product
    ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 26040
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2021-05-05

    ChloraPrep One-Step Recalled for Potential Fungal Growth and Package Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators due to a lack of assurance of sterility. The product may allow fungal growth at labeled storage conditions, potentially breaching package integrity.

    Product
    CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Distribution
    0 states