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PurPrep

povidone iodine and isopropyl alcohol · ISOPROPYL ALCOHOL 725 mg/mL; POVIDONE-IODINE 8.3 mg/mL · Sponge · Topical · CareFusion 213 LLC

NDC 54365-0014-41 · 1 APPLICATOR in 1 POUCH / 10.5 mL in 1 APPLICATOR · OTC MONOGRAPH DRUG · View full market →

The short version

Only one company currently supplies this market — there is no backup if it stumbles. 3 Class II recalls hit this product in the past year (CareFusion 213, LLC).

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Medicare Part D

Medicare Part D does not cover over-the-counter drugs — by law it pays only for products requiring a prescription.

How Part D pricing works →

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

Regulatory

Application
505G(a)(3)
TE code
—
Approval date
—
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

  • Class II · OngoingJun 11, 2026
    CareFusion 213, LLC — 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
  • Class II · OngoingApr 22, 2026
    CareFusion 213, LLC — Lack of assurance of Sterility: potential product contamination
  • Class II · OngoingApr 22, 2026
    CareFusion 213, LLC — Lack of assurance of Sterility: potential product contamination

Manufacturers of povidone iodine and isopropyl alcohol (Sponge)

LabelerStrengthFirst seenLast seen
CareFusion 213 LLCISOPROPYL ALCOHOL 725 mg/mL; POVIDONE-IODINE 8.3 mg/mLJul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "PurPrep — NDC 54365-0014-41," retrieved September 3, 2026, https://drugdashboards.com/drug/54365001441.

Free to cite with attribution — see how the data is put together.