Carefusion 213, Llc: Bd Chloraprep Clear (2% W/v Chlorhexidine Gluconate (chg) And 70% V/v Isopropyl Alcohol (ipa))
BD ChloraPrep Clear Recall Summary BD ChloraPrep Clear, a skin antiseptic solution sold in 1 mL applicators, is being recalled nationwide because some batches contain Aspergillus penicillioides fungal contamination, making them non-sterile. This is a Class I recall affecting product NDC 54365-400-31 distributed across all U.S. states and some foreign countries. The product is used medically to prepare skin before procedures.
- Recalling firm
- CareFusion 213, LLC
- Product
- BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.
- Reason
- Non-Sterility: Due to presence of Aspergillus penicillioides.
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-28
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide inthe USA, as well as other foreign distribution.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/74232b31-ba81-4dff-aad7-ab60704ea537