FDA requests label and packaging changes for certain topical antiseptic products

SILVER SPRING, Md. — The Food and Drug Administration has requested label and packaging changes of certain over-the-counter topical antiseptic products, according to an FDA MedWatch alert emailed Thursday. "We are requesting that manufacturers package antiseptics indicated for preoperative or preinjection skin preparation in single-use containers," the alert stated. "The antiseptics in these single-use containers should be applied only one time to one patient. We also recommend that healthcare professionals and patients do not dilute antiseptic products after opening them. Applicators and any unused solution should be discarded after the single application."

"This request is the result of our ongoing evaluation of infrequent but continuing reports of infections resulting from antiseptic products labeled for preoperative or preinjection skin preparation," the agency stated. "When used properly, topical antiseptics are safe and effective products to reduce the number of bacteria on patients’ skin prior to surgery or injections. However, most often, contamination of topical antiseptics occurs when organisms are introduced into the product by users. Therefore, healthcare professionals and patients should follow all label directions to decrease the chances of infection."

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. Clinical infections also have been reported to the FDA, leading to some product recalls. These infections have been confirmed to be caused by contaminated antiseptic products. Affected products included all commonly used antiseptic ingredients, including alcohol, iodophors, chlorhexidine gluconate and quaternary ammonium products.  

Topical antiseptics are not required to be manufactured as sterile and so may become contaminated with bacteria during manufacturing. Labeling stating a product is sterile means it was treated with a process during manufacturing to eliminate all potential microorganisms. However, even topical antiseptics manufactured with a sterile process can become contaminated if proper care is not taken when using them, the agency noted.