Recalls / Class II
Class IID-0243-2026
Product
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG), 2% w/v and Isopropyl alcohol (IPA), 70% v/v), 5.25 mL Applicator, CareFusion 213, LLC, El Paso, TX 79912, NDC 54365-401-29
- Brand name
- Chloraprep Swabstick
- Generic name
- Chlorhexidine Gluconate And Isopropyl Alcohol
- Active ingredients
- Chlorhexidine Gluconate, Isopropyl Alcohol
- Route
- Topical
- NDC
- 54365-401
- FDA application
- NDA021555
- Affected lot / code info
- Lot #: 5086623, Exp. Date 03/31/2028
Why it was recalled
Lack of Assurance of Sterlity
Recalling firm
- Firm
- CareFusion 213, LLC
- Manufacturer
- CareFusion 213 LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1550 Northwestern Dr, N/A, El Paso, Texas 79912-8000
Distribution
- Quantity
- 106,400 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2025-12-17
- FDA classified
- 2025-12-30
- Posted by FDA
- 2026-01-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0243-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.