FDA DrugsClass II
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropy...
Published: July 8, 2026Recall ID: D-0645-2026Category: 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 ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400-32, bulk Catalog 930500NSB, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.
Additional Source Details
| Field | Value |
|---|---|
| City | El Paso |
| State | TX |
| Openfda › Unii › 1 | MOR84MUD8E |
| Openfda › Unii › 2 | ND2M416302 |
| Openfda › Route | TOPICAL |
| Openfda › Rxcui › 1 | 858726 |
| Openfda › Rxcui › 2 | 998282 |
| Openfda › Spl id | 42641d19-c870-7770-e063-6294a90acf97 |
| Openfda › Brand name | CHLORAPREP ONE-STEP |
| Openfda › Spl set id | 8529596f-37e4-c44e-e053-2a91aa0ad014 |
| Openfda › Package ndc | 54365-400-32 |
| Openfda › Product ndc | 54365-400 |
| Openfda › Generic name | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name › 1 | CHLORHEXIDINE GLUCONATE |
| Openfda › Substance name › 2 | ISOPROPYL ALCOHOL |
| Openfda › Manufacturer name | CareFusion 213, LLC |
| Openfda › Application number | NDA020832 |
| Openfda › Is original packager | true |
| Event id | 99217 |
| Address 1 | 1550 Northwestern Dr |
| Address 2 | N/A |
| Code info | Lot: (a) 3214024, 3199359, 3200136, Exp 6/30/2026, 3212372, Exp. 7/31/2026, 3237018, 3243267, 3264290, Exp. 8/31/2026, 3313291, Exp. 10/31/2026, 3334121, Exp. 11/30/2026, 4030693, 4033380, Exp 1/31/2027, 4058103, 4065931, Exp. 2/28/2027, 4093245, 4094302, Exp. 3/31/2027, 4145548, 4146564, Exp. 5/31/2027, 4191049, Exp 6/30/2027, 4214794, 4218807, Exp. 7/31/2027, 4249036, Exp. 8/31/2027, 4254217, 4330005, 4277387, 4275877, 4276225, 4276231, Exp. 9/30/2027, 4304554, 4304577, 4305852, Exp. 10/31/2027, 4332555, Exp. 11/30/2027, 4348701, 4366429, Exp. 12/31/2027, 5016607, 5016609, 5017377, 5018775, Exp. 1/31/2028, 5050801, 5050107, Exp. 2/29/2028, 5076869, 5077722, 5079413, Exp. 3/31/2028, 5112405, 5106576, 5111556, 5118607, 5119243, 5119244, 5127658, Exp. 4/30/2028, 5139589, 5154809, 5157377, Exp. 5/31/2028, 5160633, 5160695, 5177477, Exp.6/30/2028, 5195773, 5195785, 5210771, 5210773, 5210784, 5219294, Exp. 7/31/2028, 5233581, 5247554, 5247987, Exp. 8/31/2028, 5310578, Exp.10/31/2028, 53... [TRUNCATED] |
| Postal code | 79912-8000 |
| Report date | 20260708 |
| Product type | Drugs |
| Product quantity | 146,600 units |
| 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