Maxipan Bakery Corp, of West Hempstead, NY, is recalling its 8 ounce packages of “Semita De Pina� because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if they consume this product.
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Category Archives: Food Safety News
FDA approves first insomnia drug for middle-of-the-night waking followed by difficulty returning to sleep
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.
FDA takes enforcement action against Pennsylvania dietary supplement maker
The FDA today took legal action against a dietary supplement maker and owner for substituting ingredients and products without noting the changes on the final product labels. The permanent injunction, filed on behalf of the FDA by the U.S. Department of Justice, would stop the defendants from making and distributing more than 400 products for being in violation of the Federal Food, Drug, and Cosmetic Act.
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Rio Grande Imports Inc. Issues Allergy Alert on Undecared Dairy in Semita de Piña (Pineapple Jam Filled Pastry)
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.
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FDA permits marketing of a system to repair failed, problematic fix for aortic aneurysms
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.
FDA approves Eylea for eye disorder in older people
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.
FDA warns consumers not to eat one batch of Loyd Grossman Korma Sauce
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.
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FDA approves Erwinaze to treat a form of leukemia
The U.S. Food and Drug Administration today approved Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs used to treat ALL.
FDA Commissioner announces Avastin decision
FDA Commissioner Margaret A. Hamburg, M.D., said today she is revoking the agency’s approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.
FDA approves first supplemental test for Chagas disease
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.