Archive for February 2008

FDA Issues Early Communication about an Ongoing Review of Vytorin

The U.S. Food and Drug Administration today issued an Early Communication regarding the agency’s ongoing review of Vytorin based on preliminary results from a recently completed study — the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) — on this cholesterol lowering…

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FDA Warns Public of Possible Botulism Risk

The U.S. Food and Drug Administration (FDA) today announced that New Era Canning Company, New Era, Mich., is expanding its product recall because of potential Clostridium botulinum (C. botulinum) contamination to all canned green beans and garbanzo beans distributed by the company nationwide over the last five years. C. botulinum can cause botulism, a serious…

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New Era Canning Company Expands Nationwide Recall

The U.S. Food and Drug Administration (FDA) is alerting consumers, food service operators, and food retailers that New Era Canning Company, New Era, Mich., is broadening its nationwide recall of canned vegetable products for a third time because of the potential for its foods to be contaminated with Clostridium botulinum (C. botulinum).

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FDA Advises Seafood Processors About Ciguatera Fish Poisoning in the Northern Gulf of Mexico Near the Flower Garden Banks National Marine Sanctuary

Agency updates guidance to seafood processors after recent illnesses. The U.S. Food and Drug Administration (FDA) today issued a letter to seafood processors, advising them of recent illnesses linked to consuming fish carrying the ciguatera toxin, which has led to cases of ciguatera fish poisoning (CFP) in consumers.

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Guidance for Industry and FDA: Letter to Seafood Processors that Purchase Grouper, Amberjack, and Related Predatory Reef Species Captured In the Northern Gulf of Mexico

This letter is intended for seafood processors in the northern Gulf of Mexico and seafood processors that purchase grouper, amberjack, and related predatory reef species captured in the northern Gulf of Mexico to inform you of the FDA’s concern with a number of recent outbreaks of ciguatera fish poisoning (CFP) that have been traced to…

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