The Recall Desk
SevereFDA (Drugs)·D-0268-2021·Announced 2021-03-03

FDA Recalls Chloraprep One-Step Antiseptic Due to Non-Sterility Risk

CareFusion 213, LLC is recalling 400 cartons of Chloraprep One-Step antiseptic applicators distributed in Puerto Rico and Oman due to potential fungal growth and package integrity breaches.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which mandates a severity score of at least 4 according to the rubric, due to the reasonable probability that use of the product will cause serious adverse health consequences.

Plain-English summary

CareFusion 213, LLC is recalling 400 cartons of CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL) sterile solution applicators. The product is identified by NDC 54365-400-33 and REF 930415. The recall affects units distributed in Puerto Rico and Oman.

The recall is due to a non-sterility issue. In climatic Zone IV regions, where labeled storage conditions of 30°C/75% Relative Humidity may persist for more than 6 months, there is a potential for the growth of Aspergillus penicillioides, a type of fungus. This growth can result in a breach of the package integrity. Specific lots affected include, but are not limited to, Lot # 0107872, 0108556, 0148278, 0151978, 0155534, 0157085, 0160618, and 0167907, with expiration dates ranging from 04/30/2023 to 05/31/2023.

Healthcare providers and consumers in Puerto Rico and Oman should stop using the affected product and contact CareFusion 213, LLC for further instructions or returns.

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
400

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)

  • Exp. 04/30/2023
  • 0108556
  • 0148278
  • 0151978
  • Exp. 05/31/2023
  • 0155534
  • 0157085
  • 0160618
  • 0167907
  • Exp. 05/31/2023.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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