Medications & Supplements/Topical Products

CareFusion 213, LLC: BD ChloraPrep Recalled Due to Potential Fungal Contamination

Agency Publication Date: April 26, 2021

Summary

CareFusion 213, LLC is recalling over 108 million units of BD ChloraPrep clear and orange sterile and non-sterile solutions used for skin preparation before medical procedures. The recall was initiated because the packaging can develop a breach during storage in high humidity, allowing the fungus Aspergillus penicillioides to grow. This fungal growth compromises the sterility of the applicators and the solution, which may lead to serious infections in patients, particularly those with weakened immune systems.

Risk

A type of fungus called Aspergillus penicillioides can grow on the packaging under specific temperature and humidity conditions, causing a hole or breach in the sterile barrier. If a contaminated applicator is used during a medical procedure, the fungus could be introduced into a patient's body, potentially causing life-threatening infections.

What You Should Do

Check your medical supplies for BD ChloraPrep Clear or Hi-Lite Orange applicators (0.10 fl. oz. / 3 ml) in 25-count cartons.
Identify affected products by matching NDC numbers 54365-400-32, 54365-400-33, 054365-400-01, or 054365-400-11 on the carton or applicator.
Verify if your lot numbers and expiration dates match the extensive list provided in the recall notice, including lots such as 0065386 (Exp 2/28/2023), 0107872 (Exp 4/30/2023), and 8081571 (Exp 3/31/2021).
Immediately stop using any affected products and sequester them to prevent use in clinical settings.
Contact your healthcare provider or pharmacist for guidance regarding any procedures where these products may have been used.
Return any unused, affected product to the place of purchase or pharmacy for a refund and contact the manufacturer, CareFusion 213, LLC, for further return instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer for further instructions.

Affected Products

Product: BD ChloraPrep Clear, 2% CHG and 70% IPA Sterile Solution (0.10 fl. oz. / 3 ml)

Model:

REF 930400

UPC Codes:

NDC 54365-400-32

Lot Numbers:

0065386 (Exp 2/28/2023)

0085419 (Exp 3/31/2023)

0091666 (Exp 3/31/2023)

0149328 (Exp 4/30/2023)

0151977 (Exp 5/31/2023)

0161217 (Exp 5/31/2023)

0175874 (Exp 6/30/2023)

0176660 (Exp 6/30/2023)

0188805 (Exp 6/30/2023)

0211068 (Exp 7/31/2023)

Date Ranges: February 2023 - July 2023

Product: BD ChloraPrep Hi-Lite Orange 2% CHG and 70% IPA Sterile Solution (0.10 fl. oz. / 3 ml)

Model:

REF 930415

UPC Codes:

NDC 54365-400-33

Lot Numbers:

0107872 (Exp 4/30/2023)

0108556 (Exp 4/30/2023)

0148278 (Exp 4/30/2023)

0151978 (Exp 5/31/2023)

0155534 (Exp 5/31/2023)

0157085 (Exp 5/31/2023)

0160618 (Exp 5/31/2023)

0167907 (Exp 5/31/2023)

Date Ranges: April 2023 - May 2023

Product: ChloraPrep One-Step 2% CHG and 70% IPA Non-Sterile Solution - Clear (0.10 fl. oz. / 3 ml)

Model:

Cat. No. 260400

UPC Codes:

NDC 054365-400-01

Lot Numbers:

0008777 (Exp 12/31/2022)

0016325 (Exp 12/31/2022)

0021072 (Exp 1/31/2023)

0027041 (Exp 1/31/2023)

8081571 (Exp 3/31/2021)

9352330 (Exp 12/31/2022)

Date Ranges: March 2021 - June 2023

Product: ChloraPrep With Tint 2% CHG and 70% IPA Non-Sterile Solution - Hi-Lite Orange (0.10 fl. oz. / 3 ml)

Model:

Cat. No. 260415

UPC Codes:

NDC 054365-400-11

Lot Numbers:

0011737 (Exp 1/31/2023)

0020739 (Exp 1/31/2023)

0044734 (Exp 12/31/2022)

8116723 (Exp 4/30/2021)

9345911 (Exp 11/30/2022)

Date Ranges: March 2021 - February 2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87592

Status: Resolved

Manufacturer: CareFusion 213, LLC

Sold By: Hospitals; Pharmacies; Medical Supply Distributors

Manufactured In: United States

Units Affected: 8 products (952,100 cartons; 1,434,000 cartons; 11,115,774 cartons; 6,869,400 cartons; 24,969,700 cartons; 14,275,400 cartons; 40,720,900 cartons; 7,990,100 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 · FDA Press Release · 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.

Summary

Risk

What You Should Do

Check your medical supplies for BD ChloraPrep Clear or Hi-Lite Orange applicators (0.10 fl. oz. / 3 ml) in 25-count cartons.

Identify affected products by matching NDC numbers 54365-400-32, 54365-400-33, 054365-400-01, or 054365-400-11 on the carton or applicator.

Verify if your lot numbers and expiration dates match the extensive list provided in the recall notice, including lots such as 0065386 (Exp 2/28/2023), 0107872 (Exp 4/30/2023), and 8081571 (Exp 3/31/2021).

Immediately stop using any affected products and sequester them to prevent use in clinical settings.

Contact your healthcare provider or pharmacist for guidance regarding any procedures where these products may have been used.

Return any unused, affected product to the place of purchase or pharmacy for a refund and contact the manufacturer, CareFusion 213, LLC, for further return instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: BD ChloraPrep Clear, 2% CHG and 70% IPA Sterile Solution (0.10 fl. oz. / 3 ml)

Model:

REF 930400

UPC Codes:

NDC 54365-400-32

Lot Numbers:

0065386 (Exp 2/28/2023)

0085419 (Exp 3/31/2023)

0091666 (Exp 3/31/2023)

0149328 (Exp 4/30/2023)

0151977 (Exp 5/31/2023)

0161217 (Exp 5/31/2023)

0175874 (Exp 6/30/2023)

0176660 (Exp 6/30/2023)

0188805 (Exp 6/30/2023)

0211068 (Exp 7/31/2023)

Date Ranges: February 2023 - July 2023

Product: BD ChloraPrep Hi-Lite Orange 2% CHG and 70% IPA Sterile Solution (0.10 fl. oz. / 3 ml)

Model:

REF 930415

UPC Codes:

NDC 54365-400-33

Lot Numbers:

0107872 (Exp 4/30/2023)

0108556 (Exp 4/30/2023)

0148278 (Exp 4/30/2023)

0151978 (Exp 5/31/2023)

0155534 (Exp 5/31/2023)

0157085 (Exp 5/31/2023)

0160618 (Exp 5/31/2023)

0167907 (Exp 5/31/2023)

Date Ranges: April 2023 - May 2023

Product: ChloraPrep One-Step 2% CHG and 70% IPA Non-Sterile Solution - Clear (0.10 fl. oz. / 3 ml)

Model:

Cat. No. 260400

UPC Codes:

NDC 054365-400-01

Lot Numbers:

0008777 (Exp 12/31/2022)

0016325 (Exp 12/31/2022)

0021072 (Exp 1/31/2023)

0027041 (Exp 1/31/2023)

8081571 (Exp 3/31/2021)

9352330 (Exp 12/31/2022)

Date Ranges: March 2021 - June 2023

Product: ChloraPrep With Tint 2% CHG and 70% IPA Non-Sterile Solution - Hi-Lite Orange (0.10 fl. oz. / 3 ml)

Model:

Cat. No. 260415

UPC Codes:

NDC 054365-400-11

Lot Numbers:

0011737 (Exp 1/31/2023)

0020739 (Exp 1/31/2023)

0044734 (Exp 12/31/2022)

8116723 (Exp 4/30/2021)

9345911 (Exp 11/30/2022)

Date Ranges: March 2021 - February 2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87592

Status: Resolved

Manufacturer: CareFusion 213, LLC

Sold By: Hospitals; Pharmacies; Medical Supply Distributors

Manufactured In: United States

Units Affected: 8 products (952,100 cartons; 1,434,000 cartons; 11,115,774 cartons; 6,869,400 cartons; 24,969,700 cartons; 14,275,400 cartons; 40,720,900 cartons; 7,990,100 cartons)

Distributed To: Nationwide