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FDA requests label change to antiseptics after outbreaks
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The U.S. Food and Drug Administration said it is requesting that manufacturers package antiseptics indicated for preoperative or preinjection skin preparation in single-use containers. The FDA also told health care professionals in a memo to ensure that the products are used according to the directions on the label and to apply the antiseptics in single-use containers to only one patient at one time.
The FDA said it is requesting these packaging changes after receiving reports of outbreaks associated with the use of contaminated topical antiseptics.
"Outbreaks associated with the use of contaminated topical antiseptics have been reported in the medical literature and to the Centers for Disease Control and Prevention (CDC)," the FDA said. "Clinical infections have also been reported to FDA, leading to some product recalls."
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