FDA News

The U.S. Food and Drug Administration today approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.

IDS Sports announced today that it is
conducting a voluntary nationwide recall of five of the company’s dietary supplement products sold
under the following names: Bromodrol, Dual Action Grow Tabs, Grow Tabs, Mass Tabs, and
Ripped Tabs TR.
The Food And Drug Administration (FDA) has notified IDS Sports that the recalled products contain the
following undeclared substances, which FDA considers to be

Today, ConAgra Foods, in cooperation with the U.S. Food and Drug Administration (FDA) is voluntarily recalling a limited number of 15 oz. tubs of Blue Bonnet Spread that were inadvertently mispackaged—the lid is for regular Blue Bonnet Spread and the tub portion describes the product as Blue Bonnet Light Spread. The product inside of the tub is regular Blue Bonnet Spread.

Several weeks ago, the FDA announced its intent to change, by summer 2011, its policy regarding the post-harvest processing of raw Gulf Coast oysters harvested in the warmer months.

Reports of chondrolysis in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices.

The U.S. Food and Drug Administration today cleared for marketing the Platelet PGD Test System, the first rapid test for the detection of bacterial contamination in pooled platelets derived from whole blood.

Foreign particle contamination of several products manufactured by Genzyme, which may lead to serious adverse events including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions.

Herbal Products, Inc. has been informed by the Food and Drug Administration (FDA) that Pai You Guo, a weight loss dietary supplement, sold and marketed by the firm contains undeclared drug ingredients.

The Food and Drug Administration today notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against seafood processor Haifa Smoked Fish Inc. of Jamaica, N.Y., and two of its top officers for violations of the Federal Food, Drug and Cosmetic Act.