The Recall Desk
CriticalFDA (Drugs)·D-0344-2021·Announced 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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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 per the rubric.

Plain-English summary

CareFusion 213, LLC is recalling 1,434,000 cartons of ChloraPrep One-Step (Chlorhexidine Gluconate and Isopropyl Alcohol) sterile solution applicators. The recall is due to a non-sterility issue where growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity at labeled storage conditions of 30°C/75% Relative Humidity.

The affected product is BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), sterile solution, 0.10 fl. oz. (3 ml) each, 25 applicators per carton. The specific lots and expiration dates affected are: 0107872 (4/30/2023), 0108556 (4/30/2023), 0148278 (4/30/2023), 0151978 (5/31/2023), 0155534 (5/31/2023), 0157085 (5/31/2023), 0160618 (5/31/2023), and 0167907 (5/31/2023).

The product was distributed nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, and Brazil. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be stopped from use and returned to the supplier or disposed of according to local regulations, as the package integrity breach compromises the sterile status of the applicators.

The recalled product

Product
CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Brand
CHLORAPREP ONE-STEP
Manufacturer
CareFusion 213, LLC
Category
Drug — Topical Antiseptic
Hazard
Affected units
1,434,000

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 (10)

  • Lot and Exp Date: 0107872
  • 4/30/2023
  • 0108556
  • 0148278
  • 0151978
  • 5/31/2023
  • 0155534
  • 0157085
  • 0160618
  • 0167907

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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