Medications & Supplements/Topical Products

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

Agency Publication Date: February 19, 2021

Summary

CareFusion 213, LLC is recalling 1,704 cartons of various BD ChloraPrep 2% chlorhexidine gluconate and 70% isopropyl alcohol skin preparation applicators. These products, used for skin preparation before medical procedures, were distributed in Puerto Rico and Oman and are being recalled because the packaging may fail under high humidity conditions. This failure can allow the growth of Aspergillus penicillioides fungus, which could contaminate the solution or the applicator itself. Consumers who have these specific lots should contact their healthcare provider and return the product for a refund.

Risk

If the packaging seal is breached due to fungal growth, the solution may no longer be sterile or safe for use. Applying a contaminated product to a patient's skin before a medical procedure could lead to serious infections, particularly in vulnerable patients or those with weakened immune systems.

What You Should Do

Identify if you have the affected BD ChloraPrep products by checking for these specific lot numbers and expiration dates: 0107872 (Exp 04/30/2023), 0108556 (Exp 04/30/2023), 0148278 (Exp 04/30/2023), 0151978 (Exp 05/31/2023), 0155534 (Exp 05/31/2023), 0157085 (Exp 05/31/2023), 0160618 (Exp 05/31/2023), 0167907 (Exp 05/31/2023), 0161217 (Exp 05/31/2023), 0211068 (Exp 07/31/2023), 0176660 (Exp 06/30/2023), 0188805 (Exp 06/30/2023), 0175874 (Exp 06/30/2023), 0151977 (Exp 05/31/2023), 0149328 (Exp 04/30/2023), 0085419 (Exp 03/31/2023), 0038209 (Exp 01/31/2023), 0098528 (Exp 02/28/2023), 0192894 (Exp 06/30/2023), or 9080812 (Exp 03/31/2022).
Check the National Drug Code (NDC) and Reference/Catalog numbers on the packaging: NDC 54365-400-33 (REF 930415), NDC 54365-400-32 (REF 930400), NDC 054365-400-11 (Cat. No. 260415), or NDC 054365-400-01 (Cat. No. 260400).
Contact your healthcare provider or pharmacist immediately for guidance if you have been using these products and are concerned about your health.
Return any unused product to the pharmacy or place of purchase for a full refund and to ensure the items are properly removed from the supply chain.
Contact the manufacturer, CareFusion 213, LLC, for further instructions regarding this recall.
For additional questions, you can contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: BD ChloraPrep Hi-Lite Orange 2% w/v CHG and 70% v/v IPA, Sterile Solution (0.01 fl. oz. / 3 ml)

Model:

REF 930415

NDC 54365-400-33

Lot Numbers:

0107872 (Exp 04/30/2023)

0108556 (Exp 04/30/2023)

0148278 (Exp 04/30/2023)

0151978 (Exp 05/31/2023)

0155534 (Exp 05/31/2023)

0157085 (Exp 05/31/2023)

0160618 (Exp 05/31/2023)

0167907 (Exp 05/31/2023)

Date Ranges: 04/30/2023, 05/31/2023

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

Model:

REF 930400

NDC 54365-400-32

Lot Numbers:

0161217 (Exp 05/31/2023)

0211068 (Exp 07/31/2023)

0176660 (Exp 06/30/2023)

0188805 (Exp 06/30/2023)

0175874 (Exp 06/30/2023)

0151977 (Exp 05/31/2023)

0149328 (Exp 04/30/2023)

0085419 (Exp 03/31/2023)

Date Ranges: 03/31/2023, 04/30/2023, 05/31/2023, 06/30/2023, 07/31/2023

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

Model:

Cat. No. 260415

NDC 054365-400-11

Lot Numbers:

0038209 (Exp 01/31/2023)

0098528 (Exp 02/28/2023)

Date Ranges: 01/31/2023, 02/28/2023

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

Model:

Cat. No. 260400

NDC 054365-400-01

Lot Numbers:

0192894 (Exp 06/30/2023)

9080812 (Exp 03/31/2022)

Date Ranges: 03/31/2022, 06/30/2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86998

Status: Resolved

Manufacturer: CareFusion 213, LLC

Sold By: Hospitals; Pharmacies; Medical Supply Distributors

Manufactured In: United States

Units Affected: 4 products (988 cartons; 36 cartons; 280 cartons; 400 cartons)

Distributed To: Puerto Rico

Agency Last Updated: September 29, 2022

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.

Summary

What You Should Do

Identify if you have the affected BD ChloraPrep products by checking for these specific lot numbers and expiration dates: 0107872 (Exp 04/30/2023), 0108556 (Exp 04/30/2023), 0148278 (Exp 04/30/2023), 0151978 (Exp 05/31/2023), 0155534 (Exp 05/31/2023), 0157085 (Exp 05/31/2023), 0160618 (Exp 05/31/2023), 0167907 (Exp 05/31/2023), 0161217 (Exp 05/31/2023), 0211068 (Exp 07/31/2023), 0176660 (Exp 06/30/2023), 0188805 (Exp 06/30/2023), 0175874 (Exp 06/30/2023), 0151977 (Exp 05/31/2023), 0149328 (Exp 04/30/2023), 0085419 (Exp 03/31/2023), 0038209 (Exp 01/31/2023), 0098528 (Exp 02/28/2023), 0192894 (Exp 06/30/2023), or 9080812 (Exp 03/31/2022).

Check the National Drug Code (NDC) and Reference/Catalog numbers on the packaging: NDC 54365-400-33 (REF 930415), NDC 54365-400-32 (REF 930400), NDC 054365-400-11 (Cat. No. 260415), or NDC 054365-400-01 (Cat. No. 260400).

Contact your healthcare provider or pharmacist immediately for guidance if you have been using these products and are concerned about your health.

Return any unused product to the pharmacy or place of purchase for a full refund and to ensure the items are properly removed from the supply chain.

Contact the manufacturer, CareFusion 213, LLC, for further instructions regarding this recall.

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

Affected Products

Product: BD ChloraPrep Hi-Lite Orange 2% w/v CHG and 70% v/v IPA, Sterile Solution (0.01 fl. oz. / 3 ml)

Model:

REF 930415

NDC 54365-400-33

Lot Numbers:

0107872 (Exp 04/30/2023)

0108556 (Exp 04/30/2023)

0148278 (Exp 04/30/2023)

0151978 (Exp 05/31/2023)

0155534 (Exp 05/31/2023)

0157085 (Exp 05/31/2023)

0160618 (Exp 05/31/2023)

0167907 (Exp 05/31/2023)

Date Ranges: 04/30/2023, 05/31/2023

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

Model:

REF 930400

NDC 54365-400-32

Lot Numbers:

0161217 (Exp 05/31/2023)

0211068 (Exp 07/31/2023)

0176660 (Exp 06/30/2023)

0188805 (Exp 06/30/2023)

0175874 (Exp 06/30/2023)

0151977 (Exp 05/31/2023)

0149328 (Exp 04/30/2023)

0085419 (Exp 03/31/2023)

Date Ranges: 03/31/2023, 04/30/2023, 05/31/2023, 06/30/2023, 07/31/2023

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

Model:

Cat. No. 260415

NDC 054365-400-11

Lot Numbers:

0038209 (Exp 01/31/2023)

0098528 (Exp 02/28/2023)

Date Ranges: 01/31/2023, 02/28/2023

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

Model:

Cat. No. 260400

NDC 054365-400-01

Lot Numbers:

0192894 (Exp 06/30/2023)

9080812 (Exp 03/31/2022)

Date Ranges: 03/31/2022, 06/30/2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86998

Status: Resolved

Manufacturer: CareFusion 213, LLC

Sold By: Hospitals; Pharmacies; Medical Supply Distributors

Manufactured In: United States

Units Affected: 4 products (988 cartons; 36 cartons; 280 cartons; 400 cartons)

Distributed To: Puerto Rico

Agency Last Updated: September 29, 2022