Nature Relief is voluntarily recalling Nature Relief Instant Wart and Mole Remover. Consumers are advised to discontinue use and immediately dispose of any used or unused portions of the product.
FDA modifies dosing recommendations for Erythropoiesis-Stimulating Agents
The U.S. Food and Drug Administration today recommended more conservative dosing guidelines for Erythropoiesis-Stimulating Agents (ESAs) when used to treat anemia in patients with chronic kidney disease (CKD) because of the increased risks of cardiovascular events such as stroke, thrombosis, and death.
Dole Fresh Vegetables Announces Precautionary Recall of Limited Number of Italian Blend Salads
Dole Fresh Vegetables is voluntarily recalling 2,880 cases of DOLE® Italian Blend salad with Use-by Date of June 19, 2011, UPC code 7143000819 and Product Codes 0049A157201A, 0049A157201B, 0049A157202A, 0049A157202B, 0686A157202A, 0686A157202B and 442 cases of Kroger Fresh Selections Italian Style Blend salad with Use-by-Date of June 19, 2011, UPC code 1111091045 and Product Codes A157201A & A157201B, due to a possible health risk from Listeria monocytogenes. Dole Fresh Vegetables is coordinating closely with regulatory officials.
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FDA provides updated safety data on silicone gel-filled breast implants
The U.S. Food and Drug Administration released a report today updating the clinical and scientific information for silicone gel-filled breast implants, including preliminary safety data from studies conducted by the manufacturers as a condition of their November 2006 approval.
FDA: Maryland food manufacturer enters into consent decree
The U.S. Food and Drug Administration announced that Sungwon Inc of Columbia, a Columbia, Md., corporation, and the company’s president, Sang Ja Lee, have signed a consent decree of permanent injunction.
HHS RELEASE: FDA unveils final cigarette warning labels
The U.S. Food and Drug Administration (FDA) today unveiled the nine graphic health warnings required to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement. This bold measure will help prevent children from smoking, encourage adults who do to quit, and ensure every American understands the dangers of smoking.
FDA approves first generic versions of the antibiotic levofloxacin to treat certain infections
The U.S. Food and Drug Administration today approved the first generic versions of Levaquin (levofloxacin), an antibiotic approved to treat certain infections in people ages 18 and older.
Levofloxacin is used to treat mild, moderate, or severe bacterial infections of the skin, sinuses, kidneys, bladder, and prostate caused by specific germs. It also is used to treat certain bacterial infections that cause bronchitis or pneumonia, and to treat those exposed to inhalational anthrax.
FDA examines ways to improve consumer understanding of prescription drug ads
Findings from three studies conducted by the U.S. Food and Drug Administration confirm that the way information is conveyed and displayed in printed drug advertising affects consumer understanding of prescription medications.
FDA issues draft guidance for early version of an artificial pancreas system
The U.S. Food and Drug Administration today issued draft guidance that will help advance the development and approval of an artificial pancreas system to treat type 1 diabetes in the United States.
FDA unveils new global strategy to help ensure safety and quality of imported products
The U.S. Food and Drug Administration today unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the “Pathway to Global Product Safety and Quality.”