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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- CareFusion 213, LLC
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0266-2021
Related Recalls
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.
Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.