FDA Drug recall D-1168-2023
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 appl…
- FDA Drug
- Class II
- completed
- Published 2023-09-27
On 2023-09-27 the FDA classified a Class II recall of BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.03mL (1 ml) each, 60 appl… by Carefusion 213, citing 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-m….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1168-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-08-25 |
| Published | 2023-09-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Carefusion 213 |
| Distribution | US |
Product
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).
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.
Identifiers
| ndc | 54365-400-31 |
|---|---|
| code_info | Lot # 2272350, Exp. Date 09/30/2025 and Lot # 2301939, Exp. Date 09/30/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1168-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.