CLASS I Drug recall · Reported 3 Mar 2021 · FDA Enforcement Report
ChloraPrep With Tint 2% w/v chlorhexidine gluconate recalled
CareFusion 213 is recalling ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol, distributed in Puerto Rico. The recall was initiated on 7 Jul 2020 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0266-2021
- FDA event ID
- 86998
- Recalling firm
- CareFusion 213, El Paso, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 7 Jul 2020
- FDA classified
- 19 Feb 2021
- Reported
- 3 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 7 Jul 2020 | Recall initiated by company | |
| 19 Feb 2021 | Classified by FDA | +227 days |
| 3 Mar 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415
Where it was distributed
Distributed in Puerto Rico and Oman
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: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.
Which lots are affected?
All lots including but not limited to the following lots distributed in Zone IV: Lot # 0038209, Exp. 01/31/2023; 0098528, Exp. 02/28/2023.
Where was it sold?
Distributed in Puerto Rico and Oman
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 86998| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | PR | |
| CLASS I | BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | PR | |
| CLASS I | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) recalled | CareFusion 213 | Sterility | PR |
More recalls from CareFusion 213
All 48| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step | CareFusion 213 | Sterility | Nationwide |