Archive for November, 2011
The U.S. Food and Drug Administration today approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.
Tags: fda press release
Rio Grande Imports Inc. of Copiague NY is recalling 50 cases of Semita de Piña because it may contain undeclared dairy. People who have an allergy or severe sensitivity to dairy run the risk of serious or life-threatening allergic reaction if they consume these products.
Tags: FDA Recalls
The U.S. Food and Drug Administration today allowed marketing of the first system that can repair a failed or problematic aortic endograft, a fabric tube used to repair a dangerously large aortic aneurysm, a bulge in the large blood vessel that carries blood away from the heart.
Tags: fda press release
Diamond Crystal Brands Inc. of Savannah, Ga., ISSUES ALLERGEN ALERT FOR UNDECLARED MILK in 12-ounce GFS sugar canisters that were inadvertently filled with non-dairy coffee creamer. These items were shipped in 24-can cases labeled GFS non-dairy coffee creamer.
Tags: FDA Recalls
The U.S. Food and Drug Administration today approved Eylea (aflibercept) to treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older.
AMD gradually destroys a person’s sharp, central vision.
Tags: fda press release
Fast Facts
• FDA is warning consumers not to eat Loyd Grossman Korma Sauce in 350 ml jars with the batch code 1218R and sell by date of February 2013.
• The distributor of this product, Premier Foods in England, is recalling this batch of Loyd Grossman Korma Sauce. This product has been linked to two cases of botulism in Scotland.
• There are no reported cases of illness related to this product in the United States.
• The product is not believed to be distributed in the United States, but consumers may have obtained it through internet sales.
• Consumers are warned not to use the product even if it does not look or smell spoiled. Consumers should dispose of this product in a sealed container and place it in a trash receptacle for non-recyclable trash outside of the home in a manner that ensures people and animals, including wild animals, cannot get to it.
Tags: fda press release
Maumee Valley Vending Company announced a voluntary recall on Buffalo Chicken Wedge Sandwiches containing cheese, a milk product. A recall notification was initiated by Maumee Valley Vending Co. because milk was not listed in the ingredients on the label. The total production for this product was three hundred fifty (350) sandwiches.
Tags: food allergy
Monthly Safety Labeling Changes includes 48 products with revisions to Prescribing Information.
Tags: MedWatch Safety Alerts
The U.S. Food and Drug Administration today approved the first test for use as an additional, more specific test on human serum or plasma specimens found to be positive for antibodies to Trypanosoma cruzi (T. cruzi). T. cruzi causes Chagas disease, a serious and potentially fatal parasitic infection.
Tags: fda press release
The Food and Drug Administration (FDA) is again cautioning consumers that chicken jerky products for dogs (also sold as chicken tenders, strips or treats) may be associated with illness in dogs.
Tags: pet product recalls