Following a recent recall of potentially contaminated non-sterile alcohol prep pads, the U.S. Food and Drug Administration today reminded health care professionals about the safe use of non-sterile alcohol prep pads to clean and disinfect the surface of the skin.
Category Archives: Drug Recalls & Safety Notices
Fourth FDA orphan drug designation workshop scheduled for Feb. 28 – March 1, 2011
The U.S. Food and Drug Administration has scheduled its fourth orphan drug designation workshop for academics, biotechnology companies, and those unfamiliar with the process for Feb. 28 – March 1, 2011, in Claremont, Calif. in collaboration with Keck Graduate Institute.
FDA review indicates possible association between breast implants and a rare cancer
ALCL, breast implants
FDA approves Viibryd to treat major depressive disorder
Vlibryd, depressive disorder
Maine seafood processor enters into consent decree with FDA
The U.S. Food and Drug Administration announced today that the Portland Shellfish Co., Inc.; Jeffrey D. Holden, company president; Satyavan Singh, quality manager; and John A. Maloney, general manager, have signed a consent decree prohibiting them from distributing seafood in interstate commerce until the FDA has approved in writing the company’s Hazard Analysis and Critical Control Point (HACCP) plans, sanitation program and Listeria monocytogenes (L. mono) testing program. (DSK)
FDA Approves Head Lice Treatment for Children and Adults
The U.S. Food and Drug Administration today approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice infestation in patients ages 4 years and older.
FDA to improve most common review path for medical devices
510(k), device, innovation
Federal government obtains permanent injunction against Deltex Pharmaceuticals Inc.
The U.S. Food and Drug Administration today announced that the U.S. District Court for the Southern District of Texas entered a consent decree of permanent injunction against Deltex Pharmaceuticals Inc., of Rosenberg, Texas, its president, Kabir Ahmed, and vice president, Mohidur R. Khan.
The consent decree permanently prohibits/stops the company, Ahmed, and Khan from manufacturing and distributing drug products until Deltex’s manufacturing operations and products are in compliance with federal law and the terms of the consent decree.
FDA seeks to halt processing, distribution at New York juice company
At the request of the U.S. Food and Drug Administration, the U.S. Department of Justice today filed a complaint for permanent injunction against a Jamaica, N.Y.-based beverage company to prevent it from processing and distributing juice and other products. (DSK)
U.S. Marshals seize dental devices from Florida manufacturer
U.S. Marshals, acting under a court order sought by the U.S. Food and Drug Administration, today seized all dental devices from Rite-Dent Manufacturing Corporation, located in Hialeah, Fla. (DSK)