ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non...
FDA Drug Recall #D-0266-2021 — Class I — July 7, 2020
Recall Summary
| Recall Number | D-0266-2021 |
| 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 | 36 cartons |
Product Description
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415
Reason for Recall
Microbial Contamination of Non-Sterile Products: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 lots distributed in Zone IV: Lot # 0038209, Exp. 01/31/2023; 0098528, Exp. 02/28/2023.
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.