Some website content, social media posts and product labels from Gojo inaccurately claim the sanitizer can help prevent Ebola, flu or MRSA, among other infections, according to the warning letter.
The FDA said these claims depict Purell as a pharmaceutical drug, not an over-the-counter product. As such, Gojo must either file a new drug application to classify and market Purell as a drug or stop making the marketing claims.
Gojo must respond to the FDA’s letter detailing how it is working to address these violations by Feb. 7.
“Gojo took immediate action to respond to FDA claim requirements after receiving a warning letter from the agency,” Samantha Williams, corporate communications senior director for Gojo, said in a statement to Becker’s. “It is important to emphasize that the FDA letter was not related to the safety or quality of our products, or our manufacturing processes. Our products can and should continue to be used as part of good hand hygiene practice, to reduce germs.”
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