Recalls / Class I
Class ID-0265-2021
Product
BD ChloraPrep Clear, 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, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400
- 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
- All lots including but not limited to the following lots distributed in Zone IV: Lot # 0161217 Exp. 05/31/2023; 0211068 Exp. 07/31/2023; 0176660 Exp. 06/30/2023; 0188805 Exp. 06/30/2023; 0175874 Exp. 06/30/2023; 0151977 Exp. 05/31/2023; 0149328 Exp. 04/30/2023; 0085419 Exp. 03/31/2023
Why it was recalled
Non-sterility: 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.
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
- 988 cartons
- Distribution pattern
- Distributed in Puerto Rico and Oman
Timeline
- Recall initiated
- 2020-07-07
- FDA classified
- 2021-02-19
- Posted by FDA
- 2021-03-03
- Terminated
- 2022-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0265-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.