BD ChloraPrep Clear 2% chlorhexidine and 70% isopropyl alcohol solution may grow mold after 12 months if stored at 30°C/75% humidity. Recalled lots expire at 9/30/2025 but stability data shows risk of Aspergillus penicillioides growth beyond 12 months.
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.
BD ChloraPrep Clear sterile solution may develop mold after 12 months of storage if kept at warm, humid conditions. This could cause infections if used for medical purposes. The recall affects specific lots with expiration dates of 9/30/2025.
The solution may grow Aspergillus penicillioides mold if stored at 30°C/75% humidity for more than 12 months. This mold could cause infections if the solution is used for medical purposes after mold growth occurs.
Healthcare professionals and patients using BD ChloraPrep Clear for medical procedures are affected. Those using the product beyond 12 months without proper storage conditions are at higher risk of infection.
Check for lot numbers 2272350 or 2301939 with expiration date 09/30/2025 on the packaging. The product comes in 60 sterile applicators per carton.
Look for lot numbers 2272350 or 2301939 on the packaging with expiration date 09/30/2025.
The stability data shows that the solution may grow Aspergillus penicillioides mold if stored at 30°C/75% humidity beyond 12 months, which could cause infections if used after mold growth.
The recall record does not specify a remedy, so check the lot number and expiration date to see if it's affected. If it is, contact the manufacturer for guidance.
The product is safe for up to 12 months from the date of manufacture if stored at 30°C/75% humidity. Beyond 12 months, mold growth risk increases.
We’ve drafted a message you can send BD ChloraPrep to request your refund or repair — edit it as you like.
Subject: Recall D-1168-2023 — BD ChloraPrep BD ChloraPrep Hello, I own a BD ChloraPrep that is covered by recall D-1168-2023 from BD ChloraPrep. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
