March 23, 2021 – BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) has expanded a voluntary recall that was initiated on June 23, 2020 for specified catalog numbers of the ChloraPrep 3 mL applicator due to possible fungal contamination under certain environmental conditions.
BD has determined that storage of the ChloraPrep 3 mL Applicator in regions of the world with high heat and humidity, where product may be continuously exposed to temperatures of 86 degrees Fahrenheit and 75% relative humidity for more than six months, allows the growth of Aspergillus penicillioides.
The company says that there has been no identified risk associated with the sterile ChloraPrep antiseptic solution within the applicator.
Out of an abundance of caution and in consultation with the U.S. Food and Drug Administration (FDA), BD has expanded the recall to include all U.S. states.
The FDA has designated the recall as Class I, which they define as a situation in which there is a reasonable probability that the use of the product may cause serious adverse health consequences or death.
To date, no complaints, adverse events, injuries, or deaths have been reported related to this voluntary recall.
This recall does not include 3 mL applicators found in kits. It also does not include any other ChloraPrep product presentations.
All other ChloraPrep products are manufactured with different packaging materials that are not affected by this issue.
BD is implementing a global packaging change for the 3 mL product to correct this issue, which is expected to be available by the end of April in the United States.