The Recall Desk
Agency classClass IOur severity:CriticalFDA (Drugs)·D-0343-2021·Announced 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.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source metadata explicitly identifies this as an FDA Class I recall, which mandates a severity score of 5 (Critical) according to the rubric.

Plain-English summary

CareFusion 213, LLC is recalling specific lots of Chloraprep One-Step (Chlorhexidine Gluconate and Isopropyl Alcohol) sterile solution applicators. The recall involves 952,100 cartons of the product, which is distributed nationwide in the USA and to several international locations including Singapore, Chile, Oman, Colombia, the United Arab Emirates, South Africa, Kuwait, the Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, and Brazil.

The recall was initiated because the product was found to be non-sterile. At labeled storage conditions of 30°C and 75% relative humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity. The affected lots have expiration dates ranging from February 2023 to July 2023.

Consumers and healthcare providers should stop using the recalled product and contact CareFusion 213, LLC or their supplier for instructions on return or replacement. The FDA classifies this as a Class I recall, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The recalled product

Product
CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Brand
CHLORAPREP ONE-STEP
Manufacturer
CareFusion 213, LLC
Category
Drug — Antiseptic
Hazard
Affected units
952,100

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • Lot and Exp Date: 0065386
  • 2/28/2023
  • 0085419
  • 3/31/2023
  • 0091666
  • 0149328
  • 4/30/2023
  • 0151977
  • 5/31/2023
  • 0161217
  • 0175874
  • 6/30/2023
  • 0176660
  • 0188805
  • 0211068
  • 7/31/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by CareFusion 213, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same brand · CHLORAPREP ONE-STEP

Same manufacturer · CareFusion 213, LLC

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Same hazard · fungal contamination

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