The Recall Desk
ModerateFDA (Drugs)·D-1168-2023·Announced 2023-09-27

ChloraPrep One-Step Topical Applicators Recalled for Unsupported Shelf-Life Claims

BD ChloraPrep One-Step topical applicators are recalled because the 36-month shelf life is not supported by stability data; the product may develop fungal contamination beyond 12 months.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II precautionary recall based on stability data showing potential fungal growth only under specific improper storage conditions, with no reported illnesses or confirmed contamination. The labeling error (36-month expiry unsupported) constitutes a minor compliance issue.

Plain-English summary

BD ChloraPrep One-Step (2% chlorhexidine gluconate and 70% isopropyl alcohol) sterile topical applicators are being recalled. The product is supplied in 0.03 mL/1 mL single-use pouches, with 60 applicators per carton. This recall affects 398,160 cartons that were distributed nationwide to 100 consignees.

The manufacturer, CareFusion 213, LLC, initiated this precautionary recall because stability testing shows that the labeled 36-month shelf life is not substantiated. Stability studies indicate that if the affected lots are stored at 30°C and 75% relative humidity continuously beyond 12 months, they may develop growth of Aspergillus penicillioides, a fungal contaminant.

The affected lots are #2272350 and #2301939, both with expiration dates of 09/30/2025. Healthcare facilities and distributors with these lots should remove the affected products from use. Customers should refer to the full recall notice for handling instructions and to verify whether their inventory includes the affected lot numbers.

The recalled product

Product
CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
Brand
CHLORAPREP ONE-STEP
Manufacturer
CareFusion 213, LLC
Category
Drug — Surgical Preparation
Hazard
  • aspergillus-growth
  • labeling-error

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 (3)

  • Lot # 2272350
  • Exp. Date 09/30/2025 and Lot # 2301939
  • Exp. Date 09/30/2025

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · CHLORAPREP ONE-STEP

Same category