FDA DrugsClass II
BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl a...
Published: July 8, 2026Recall ID: D-0644-2026Category: drugsCountry: US
Reason for Recall / Hazard
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
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | El Paso |
| State | TX |
| Openfda › Nui › 1 | N0000175486 |
| Openfda › Nui › 2 | M0011640 |
| Openfda › Unii › 1 | ND2M416302 |
| Openfda › Unii › 2 | 85H0HZU99M |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui | 1052725 |
| Openfda › Spl id | 40add5c5-68aa-96f9-e063-6294a90a7282 |
| Openfda › Brand name | PURPREP |
| Openfda › Spl set id | a1c6e118-7861-c8d0-e053-2995a90aeaaa |
| Openfda › Package ndc › 1 | 54365-014-42 |
| Openfda › Package ndc › 2 | 54365-014-41 |
| Openfda › Product ndc | 54365-014 |
| Openfda › Generic name | POVIDONE IODINE AND ISOPROPYL ALCOHOL |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Pharm class cs | Iodine [CS] |
| Openfda › Substance name › 1 | ISOPROPYL ALCOHOL |
| Openfda › Substance name › 2 | POVIDONE-IODINE |
| Openfda › Pharm class epc | Antiseptic [EPC] |
| Openfda › Manufacturer name | CareFusion 213 LLC |
| Openfda › Application number | 505G(a)(3) |
| Openfda › Is original packager | true |
| Event id | 99217 |
| Address 1 | 1550 Northwestern Dr |
| Address 2 | N/A |
| Code info | Lot: 4298581, expires: 09/30/2026. |
| Postal code | 79912-8000 |
| Report date | 20260708 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | 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 |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260611 |
| Initial firm notification | Letter |
| Center classification date | 20260629 |
Overview
- Recalling FirmCareFusion 213, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionDistributed Nationwide in the USA