Medications & Supplements/Topical Products

BD ChloraPrep Clear 1 mL Applicator Recalled for Potential Mold Growth

Agency Publication Date: September 15, 2023

Summary

CareFusion 213, LLC is recalling 398,160 cartons of BD ChloraPrep Clear 1 mL Applicators (chlorhexidine gluconate and isopropyl alcohol) because the product may develop mold growth before its labeled expiration date. Stability tests showed that a specific mold, Aspergillus penicillioides, could grow if the product is stored in high heat and humidity for more than 12 months, even though it is labeled with a 36-month shelf life. No injuries or incidents related to this issue have been reported at this time.

Risk

The use of a contaminated skin preparation applicator can introduce mold directly into a patient's system or onto a surgical site, which could cause serious or life-threatening infections, particularly in patients with compromised immune systems.

What You Should Do

This recall affects BD ChloraPrep Clear 1 mL Applicators (NDC 54365-400-31, REF 930480) with lot numbers 2272350 and 2301939, both of which are labeled with an expiration date of 09/30/2025.
If you have health concerns, contact your healthcare provider or pharmacist.
Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution (1 ml)

Variants: 1 ml applicator, 60 applicators per carton

Model:

930480

Lot Numbers:

2272350 (Exp 09/30/2025)

2301939 (Exp 09/30/2025)

NDC:

54365-400-31

Product is packaged with one sterile applicator per pouch, 60 pouches per inner carton, and four inner cartons per shipping case.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92917

Status: Resolved

Manufacturer: CareFusion 213, LLC

Sold By: 100 consignees nationwide

Manufactured In: United States

Units Affected: 398,160 cartons

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.