ChloraPrep One-Step Topical Antiseptic Recalled for Non-Sterility
CareFusion 213, LLC is recalling ChloraPrep One-Step (chlorhexidine gluconate and isopropyl alcohol) topical applicators due to non-sterility caused by the presence of Aspergillus penicillioides fungal contamination.
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 FDA has classified this recall as Class I. Per the rubric, FDA Class I recalls with no reported hospitalizations or illnesses are scored as Severe (4), because the agency's own classification establishes the minimum threshold and non-sterility of a topical antiseptic poses meaningful risk of harm.
Plain-English summary
ChloraPrep One-Step topical antiseptic solution, manufactured by CareFusion 213, LLC, is being recalled because it does not meet sterility standards. Testing identified the presence of Aspergillus penicillioides fungal contamination in the affected product.
The recalled product is BD ChloraPrep Clear containing 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol in 1 mL applicators. Lot #4032183 with expiration date 01/31/2027 (NDC 54365-400-31) has been distributed nationwide in the USA and to other foreign countries, totaling 193,440 applicators.
Consumers and healthcare facilities currently using this product should stop use immediately. Contact CareFusion 213, LLC or consult with a healthcare provider for guidance on replacement or appropriate next steps.
The recalled product
- Product
- CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- CHLORAPREP ONE-STEP
- Manufacturer
- CareFusion 213, LLC
- Hazard
- non-sterility
- fungal-contamination
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 (2)
- Lot # 4032183
- Exp 01/31/2027
Distribution
Distributed nationwide across the United States.
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