Recalls / Class I
Class ID-1509-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32
- Brand name
- Chloraprep One-step
- Generic name
- Chlorhexidine Gluconate And Isopropyl Alcohol
- Active ingredients
- Chlorhexidine Gluconate, Isopropyl Alcohol
- Route
- Topical
- NDC
- 54365-400
- FDA application
- NDA020832
- Affected lot / code info
- Lot #: 0065386 Exp. 2/28/2023; 0091666 Exp. 3/31/2023
Why it was recalled
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Recalling firm
- Firm
- CareFusion 213, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1550 Northwestern Dr, N/A, El Paso, Texas 79912-8000
Distribution
- Quantity
- 12,500 applicators
- Distribution pattern
- Puerto Rico, Guam, United Arab Emirates, Bahrain, Brazil, Democratic Republic of the Congo, Chile, Colombia, United Kingdom of Great Britain and Northern Ireland, Hong Kong, Israel, Kuwait, Oman, Qatar, Saudi Arabia, Singapore,
Timeline
- Recall initiated
- 2020-06-23
- FDA classified
- 2020-08-19
- Posted by FDA
- 2020-08-26
- Terminated
- 2022-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1509-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.