NDC 54365-014 – PurPrep
Isopropyl Alcohol 725 mg/mL; Povidone-iodine 8.3 mg/mL · Sponge · Topical
Product NDC54365-014
Product details
- Brand name
- PurPrep
- Generic name
- Povidone iodine and isopropyl alcohol
- Labeler
- CareFusion 213 LLC
- Dosage form
- Sponge
- Route
- Topical
- Marketing category
- OTC MONOGRAPH DRUG · 505G(a)(3)
- Marketed since
- April 9, 2020
- Listing expires
- December 31, 2026
Active ingredients
- Isopropyl Alcohol 725 mg/mL
- Povidone-iodine 8.3 mg/mL
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 54365-014-41 | 1 APPLICATOR in 1 POUCH (54365-014-41) / 10.5 mL in 1 APPLICATOR | May 21, 2020 |
| 54365-014-42 | 1 APPLICATOR in 1 POUCH (54365-014-42) / 26 mL in 1 APPLICATOR | Apr 9, 2020 |
Recalls mentioning this NDC
- D-0644-2026 Jul 8, 2026 · Class II
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended… - D-0518-2026 May 13, 2026 · Class II
Lack of assurance of Sterility: potential product contamination - D-0517-2026 May 13, 2026 · Class II
Lack of assurance of Sterility: potential product contamination