FDA Drugs recall ·
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v… recall
- Recall number
- D-0441-2025
- Date
- (initiated May 15, 2025)
- Company / brand
- CareFusion 213, LLC
1550 Northwestern Dr, El Paso, TX, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 385,200 applicators
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BD ChloraPrep Clear, 2% x/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin Preparation, Sterile Solution, Applicator is sterile if package is intact, Flammable, External Use Only, 1 mL Applicator per pouch, 60 Applicators per inner carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., Made in the USA, Catalog Number 930480, NDC 54365-400-31.
Why was it recalled?
Lack of Assurance of Sterility: The affected product may exhibit an open seal on the packaging of the applicator.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #s: 3354127 and 3350974, Exp Date: 12/31/2026
Distribution
Nationwide in the U.S.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0441-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.