Roughly 400,000 Cartons of a Preoperative Antiseptic Recalled for Incorrect Expiry Dates

CareFusion 213, LLC, a subsidiary of Becton, Dickinson and Co., is recalling nearly 400,000 cartons of BD ChloraPrep Clear. According to the September 20, 2023, US Food and Drug Administration (FDA) Enforcement Report, a 36-month expiry listed on the product label is incorrect. Beyond 12 months, Aspergillus penicillioides growth is possible.

The recall affects BD ChloraPrep Clear with Sterile Solution (chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v), 60 applicators per carton (NDC 54365-400-31), from lots 2272350 (Exp. 9/30/25) and 2301939 (Exp. 9/30/25). The affected cartons were distributed throughout the United States.

CareFusion 213 voluntarily initiated the recall August 25, 2023. On September 15, 2023, the FDA designated the recall Class II, communicating that use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

BD ChloraPrep Clear is a preoperative skin preparation to reduce bacteria that could potentially cause skin infection.