The U.S. Food and Drug Administration advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009. The respiratory … [Read more...]
FDA Requires Boxed Warning for Promethazine Hydrochloride Injection
The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA’s authority to require safety labeling changes, will highlight the risk of serious tissue injury when this drug is administered incorrectly. The agency is also alerting … [Read more...]
LIFEPAK CR Plus Automated External Defibrillators
FDA notified healthcare professionals of a Class I recall of certain LIFEPAK CR Plus Automated External Defibrillators (AED) manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the affected devices to improperly analyze the heart rhythm and may cause the device to delay or fail to deliver … [Read more...]
AFC Trading & Wholesale Recalls AFC Beancurd Sheets and Sticks
AFC Trading & Wholesale, Inc., of Los Angeles, CA, recalls AFC Frozen Beancurd Sheets (8oz. & 16oz.) and AFC Frozen Beancurd Sticks (8oz.) because of it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products. No illnesses … [Read more...]
Shil La Dang Recalls Gimbob Fish Cake and Modeum, Combination, Sultok and Bean Seolki Rice Cakes Because Of Undeclared Allergens
Shining Marble Corporation dba Shil La Dang, Gardena, CA, is recalling its Gimbob (fish cake sushi), Modeum rice cake, combination rice cake, Sultok rice cake, and Bean Seolki rice cake. The Gimbob Fish Cake does not declare tempura fish, wheat, or soybean as an ingredient. The Modeum, Combination, Sultok, and Bean Seolki rice cakes do not declare … [Read more...]
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