CHLORHEXIDINE GLUCONATE Recall D-1168-2023
Description: BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 applicators in carton, applicator is sterile if package is intact. CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-31 REF 930480 Product is packaged in the following manner: There is one (1) sterile applicator (sponge) per pouch. Each inner carton contains sixty (60) pouches. There are four (4) inner cartons per shipping case (total of 240 pouches per case).
CHLORHEXIDINE GLUCONATE Recall D-1168-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1168-2023 |
| Event ID | 92917 |
| Brand | CHLORAPREP ONE-STEP |
| Generic Name | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL |
| Manufacturer | CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL |
| Original Package? | 1 |
| Active Substance | CHLORHEXIDINE GLUCONATE ISOPROPYL ALCOHOL |
| Drug Route | TOPICAL |
| Distribution | Distributed nationwide to 100 consignees. Please refer to consignee list. |
| Quantity | 398,160 cartons |
| Recall Reason | Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides. |
| Drug Classification | Class II |
| Drug Code Info | 20230927 |
| Product NDC | 54365-400 |
| Recall Initiation Date | 20230825 |
| Report Date | 20230927 |
| Classification Date | 20230915 |
| Address | 1550 Northwestern Dr El Paso, TX 79912-8000 United States |
| Recalling Firm | CareFusion 213, LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | MOR84MUD8E ND2M416302 |
| Drug Application Number | NDA020832 |
| Structured Product Labeling (SPL ID) | eea210f1-e5fb-1b4f-e053-2a95a90ab422 |
| Structured Product Labeling (SPL Set ID) | 85291b2b-40b9-07fa-e053-2a91aa0a84e4 |
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