Posted by CotoBlogzz
Rancho Santa Margarita, CA: The Department of Justice (DOJ) today announced the filing of a civil lawsuit against Laclede Inc. and its president, Michael A. Pellico, seeking to stop the distribution of over-the-counter vaginal drug products that the company makes and sells nationwide.
The lawsuit, filed on June 25, 2014, in the United States District Court for the Central District of California, seeks a permanent injunction against the defendants for the sale and distribution of four drugs: Luvena Prebiotic Vaginal Moisturizer and Lubricant; Luvena Prebiotic Enhanced Personal Lubricant; Luvena Prebiotic Feminine Wipes; and Luvena Prebiotic Daily Therapeutic Wash (Luvena Products).
According to the allegations in the complaint, the sale and distribution of the Luvena Products, which are manufactured by the company in its Rancho Dominguez, California, facility, violate various provisions of the federal Food, Drug, and Cosmetic Act.
According to the complaint, since 2010, Laclede has sold one or more of the Luvena Products without the required FDA approval. Furthermore, the complaint charges that the company has made unapproved claims that the products treat or prevent vaginal infections, including claims that have appeared on the company’s web sites, Facebook page, and Twitter feed.
The lawsuit was filed by the Justice Department Civil Division’s Consumer Protection Branch, in Washington, D.C., and is being handled by David A. Frank.
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