New data suggest that the drug Topamax (topiramate) and its generic versions increase the risk for the birth defects cleft lip and cleft palate in babies born to women who use the medication during pregnancy, the U.S. Food and Drug Administration said today.
Category Archives: Food Safety News
FDA modifies boxed warning for pulmonary arterial hypertension drug Letairis
The U.S. Food and Drug Administration today announced that monthly liver enzyme tests are no longer required for those taking Letairis tablets (ambrisentan), used to treat high blood pressure in the vessels that carry blood to the lungs (pulmonary arterial hypertension, or PAH).
FDA prompts removal of unapproved drugs from market
The U.S. Food and Drug Administration today took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products.
FDA approves new drug to treat chronic obstructive pulmonary disease
The U.S. Food and Drug Administration today approved roflumilast, a pill taken daily to decrease the frequency of flare-ups (exacerbations) or worsening of symptoms from severe chronic obstructive pulmonary disease (COPD).
Taylor Farms Pacific Announces Precautionary Recall of Broccoli items with an Expiration Date(s) 2/7/11 to 3/7/11 due to a Possible Health Risk
Taylor Farms Pacific is voluntarily recalling the follow items with the specific product codes dates in a limited distribution showing Best if Used by from 2/7/11 to 3/7/11 out of an abundance of caution due to a possible health risk from Listeria monocytogenes. No illnesses have been reported in association with the recall.
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W H & GROUP, LLC. Issues An Alert On Uneviscerated Fish
W H & Group LLC., at 287 Vandervoort Ave, Brooklyn, New York 11211 is recalling Dried Fish discovered by New York State Dept. of Agriculture and Markets Food Inspectors during a routine inspection and subsequent analysis of product by food lab personnel confirming that the fish was not eviscerated prior to processing.
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FDA: Advanced genomic test helps trace sources of foodborne illness outbreak
FDA scientists successfully used a new genome sequencing test to retrospectively examine a 2009-10 foodborne illness outbreak to help trace the source of the infection. PCE
FDA: U.S. Marshals seize food products at Tennessee company
U.S. Marshals today seized about $200,000 worth of food products from Bedford Cheese Store Inc. in Shelbyville, Tenn., after U.S. Food and Drug Administration investigators found evidence of rodents throughout the company’s facility. SY
FDA and Georgetown University Medical Center announce partnership
The U.S. Food and Drug Administration and Georgetown University Medical Center (GUMC) today announced a new partnership to stimulate innovation in regulatory science, ethics, education, and training. The partnership enhances the capabilities of both institutions to meet their common goal of improving public health.
FDA approves Edarbi to treat high blood pressure
The U.S. Food and Drug Administration today approved Edarbi tablets (azilsartan medoxomil) to treat high blood pressure (hypertension) in adults.