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 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.
United Natural Foods, Inc. Announces Updated Information For Recall Related to Gentes Foods Gordita Black Bean Tortillas Due to Possible Health Risk
United Natural Foods, Inc. today announced a correction to its previously announced recall of selected types of Gentes Foods Gordita Black Bean Tortillas, specifically to correct the previously stated date code of 12 7 11 to the revised date code of 11 6 11. United Natural Foods, Inc. is recalling this product dated 11 6 11 because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death.
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The J.M. Smucker Company Announces a Limited Voluntary Recall on Two Specific Best-If-Used-By Dates of 16 oz. Smucker’s&tm; Natural Peanut Butter Chunky Due to Possible Health Risk
The J.M. Smucker Company today announced a limited voluntary recall on two specific Best-If-Used-By dates of 16 oz. Smucker’s®® Natural Peanut Butter Chunky because it may be contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
FDA Statement on the International Tobacco Regulators’ Conference
This week, 65 representatives of health and regulatory agencies from 22 countries attended the International Tobacco Regulators’ Conference, hosted by the U.S. Food and Drug Administration and the World Health Organization Tobacco Free Initiative.
FDA approves first drug to treat a rare bone marrow disease
The U.S. Food and Drug Administration today approved Jakafi (ruxolitinib), the first drug approved to specifically treat patients with the bone marrow disease myelofibrosis.
CooperVision Announces Expanded Recall of Avaira Line of Contact Lenses Expanded Recall Involves Limited Number of Lots of Avaira Sphere Lenses
CooperVision announced today that it is expanding its worldwide recall of the Avaira brand product line of contact lenses to include a limited number of lots of Avaira Sphere contact lenses. In continued collaboration with the United States Food and Drug Administration, CooperVision is expanding the recall because it identified certain lots of Avaira Sphere lenses that did not meet its updated quality requirements due to the level of a silicone oil residue.
United Natural Foods, Inc. Expands Recall Of Foodmatch Inc. Divina Olives Due To Possible Health Risk
United Natural Foods, Inc. is recalling selected types of FoodMatch, Inc. Divina Stuffed Olives, because they have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled.
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Keime Inc dba Barry’s Vitamins Conducts a Nationwide Voluntary Recall of Virility Max Dietary Supplement: Lot Number 10090571
Keime Incorporated announced today that it is conducting a voluntary recall of one lot of the companies dietary supplement product sold under the following name: Virility Max. The company has been informed by representatives of the FDA that lab analysis by FDA for Lot 10090571, found the product contained sulfoaildenafil, an analog of sildenafil. Sildenafil is an active ingredient of an FDA approved drug for erectile dysfunction (ED), making Virility Max an unapproved drug.
FDA approves first cord blood product
The U.S. Food and Drug Administration today approved HEMACORD, the first licensed hematopoietic progenitor cells-cord (HPC-C) cell therapy.