Recalls / Class I
Class ID-0344-2021
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 Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415
- 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 and Exp Date: 0107872, 4/30/2023; 0108556, 4/30/2023; 0148278, 4/30/2023; 0151978, 5/31/2023; 0155534, 5/31/2023; 0157085, 5/31/2023; 0160618, 5/31/2023; 0167907, 5/31/2023;
Why it was recalled
Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, growth of Aspergillus penicillioides, a type of fungus, resulted in a breach of the package integrity.
Recalling firm
- Firm
- CareFusion 213, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1550 Northwestern Dr, N/A, El Paso, Texas 79912-8000
Distribution
- Quantity
- 1,434,000 cartons
- Distribution pattern
- Distributed Nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, Brazil.
Timeline
- Recall initiated
- 2021-03-19
- FDA classified
- 2021-04-26
- Posted by FDA
- 2021-05-05
- Terminated
- 2022-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0344-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.