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Recall Observatory FDA recall evidence

Drug product

BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-30.

D-0625-2026

May 28, 2026

Class I

Product summary

Firm
CareFusion 213, LLC
Event
Event 99114
Status
Ongoing
Classification
Class I
Quantity
178,000 applicators
Official record key
drug-enforcement:D-0625-2026

Official wording

Reason: Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

Code information: Lot # 4073005, Exp 03/31/2027

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility