FDA DrugsClass II
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl...
Published: July 1, 2026Recall ID: D-0622-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Product Description & Identification
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson and Co., NDC 54365-400-31.
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 | 42c769de-f1e0-b3a1-e063-6394a90ab2a1 |
| Openfda › Brand name | CHLORAPREP ONE-STEP |
| Openfda › Spl set id | 85291b2b-40b9-07fa-e053-2a91aa0a84e4 |
| Openfda › Package ndc | 54365-400-31 |
| 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 | 99114 |
| Address 1 | 1550 Northwestern Dr |
| Address 2 | N/A |
| Code info | Lot # 3201277, Exp Date: 06/30/2026; Lot # 3213912, 3214206, 3214914, 3215710, 3227485, Exp Date: 07/31/2026; Lot # 3234036, 3234037, 3236460, 3237244, 3243095, 3263576, 3263580, 3264318, Exp Date: 08/31/2026; Lot # 3266655, 3266657, 3270586, 3278714, 3279949, 3282215, 3282956, Exp Date: 09/30/2026; Lot # 3299094, 3299684, 3302529, 3301463, 3309836, 3310556, 3312230, 3314562, Exp Date: 10/31/2026; Lot # 3321426, Exp Date: 11/30/2026; Lot # 3350974, 3352268, 3354120, 3354127, 3356911, 4003299, 4013168, Exp Date: 12/31/2026; Lot # 4023898, 4024208, 4024754, 4030686, 4031689, 4032182, 4032183, 4038825, 4038826, 4043641, 4045863, 4046559, Exp Date: 1/31/2027; Lot # 4049128, 4060484, 4061622, 4062534, Exp Date: 02/28/2027; Lot # 4072323, 4081465, 4092172, 4092053, 4092057, 4093448, 4096267, 4099351, Exp Date: 03/31/2027; Lot # 4106830, 4106833, 4106834, 4123769, 4123637, 4124547, 4123599, 4131749, Exp Date: 04/30/2027; Lot # 4137704, 4139447, Exp Date: 05/31/2027 |
| Postal code | 79912-8000 |
| Report date | 20260701 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260528 |
| Initial firm notification | Letter |
| Center classification date | 20260625 |
Overview
- Recalling FirmCareFusion 213, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide inthe USA, as well as other foreign distribution.