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Recall Observatory FDA recall evidence

Drug 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.

D-0624-2026

May 28, 2026

Class I

Product summary

Firm
CareFusion 213, LLC
Event
Event 99114
Status
Ongoing
Classification
Class I
Quantity
193,440 applicators
Official record key
drug-enforcement:D-0624-2026

Official wording

Reason: Non-Sterility: Due to presence of Aspergillus penicillioides.

Code information: Lot # 4032183, Exp 01/31/2027

Distribution pattern: Nationwide inthe USA, as well as other foreign distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-Sterility: Due to presence of Aspergillus penicillioides.