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Recall Observatory FDA recall evidence

Drug product

BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB; NDC 54365-014-42.

D-0644-2026

June 11, 2026

Class II

Product summary

Firm
CareFusion 213, LLC
Event
Event 99217
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0644-2026

Official wording

Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Code information: Lot: 4298581, expires: 09/30/2026.

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility

Field note

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