ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-...

FDA Drug Recall #D-0267-2021 — Class I — July 7, 2020

Recall Summary

Recall Number D-0267-2021
Classification Class I — Serious risk
Date Initiated July 7, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm CareFusion 213, LLC
Location El Paso, TX
Product Type Drugs
Quantity 280 cartons

Product Description

ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400

Reason for Recall

Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.

Distribution Pattern

Distributed in Puerto Rico and Oman

Lot / Code Information

All lots including but not limited to the following lot distributed in Zone IV: Lot # 0192894, Exp. 06/30/2023; 9080812 Exp 03/31/2022

Other Recalls from CareFusion 213, LLC

Recall # Classification Product Date
D-0243-2026 Class II BD ChloraPrep" Triple Swabsticks (Chlorhexidine... Dec 17, 2025
D-0441-2025 Class II BD ChloraPrep Clear, 2% x/v chlorhexidine gluco... May 15, 2025
D-0259-2025 Class I BD ChloraPrep Clear 1mL Applicators, 2% w/v chl... Feb 14, 2025
D-1168-2023 Class II BD ChloraPrep Clear, 2% w/v chlorhexidine gluco... Aug 25, 2023
D-0373-2021 Class I BD ChloraPrep Hi-Lite Orange 26 mL Applicator (... Apr 20, 2021

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.