Sunday, November 24, 2013

FDA Cracking down on dietary supplements as unapproved new drug

Date Brand Name Product Description Reason/ Problem Company Details / Photo Recall Type
11/23/2013 Trader Joe’s   Seaweed salad   Undeclared Peanuts Jayone Foods, Inc. Select to View Firm Press Release Select to View Image of Product Label 454, 220, 69, 76
11/21/2013 Deseo Rebajar Inc.   Dietary Supplement   Unapproved new drug Deseo Rebajar Inc. Select to View Firm Press Release 454, 208, 54, 512
11/20/2013 Marina's German Bakery   Pastry products   Undeclared Almonds, Hazelnuts, and Walnuts Marina's German Bakery Select to View Firm Press Release Select to View Image of Product Label 454, 220, 69, 76
11/19/2013 OxyElite Pro   OxyElite Pro dietary supplement products   Products are associated with serious liver damage or acute liver failure USPlabs LLC Select to View Firm Press Release Select to View Image of Product Label 454, 69, 220
11/19/2013 Tendex   Dietary Supplements   Unapproved new drug Tendex Select to View Firm Press Release Select to View Image of Product Label 454, 512, 202, 54, 208
11/18/2013 RezzRx   Dietary Supplement   Unapproved new drug Fossil Fuel Products, LLC Select to View Firm Press Release 454, 202, 512, 208, 54
11/18/2013 Wegman’s   New England Clam Chowder   Undeclared Crab Blount Fine Foods Select to View Firm Press Release 454, 69, 76
11/16/2013 Jobbers Wholesale   Dietary Supplements   Unapproved new drug Jobbers Wholesale Select to View Firm Press Release 454, 512, 54
11/15/2013 Medtronic, Inc.   Guidewires designed to facilitate percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices   Have the potential for the coating on their surface to delaminate and detach Medtronic, Inc. Select to View Firm Press Release 454, 230
11/15/2013 Hashmi Surma   Eyeliner   High levels of lead New Reliance Traders, Inc Select to View Firm Press Release Select to View Image of Product Label 454, 197
11/14/2013 Crunch Pak   Apple slices   Listeria monocytogenes Crunch Pak Select to View Firm Press Release 454, 220, 69
11/14/2013 La Boulange   Soft caramel jam product   Undeclared Hazelnuts La Boulange Cafe & Bakery Select to View Firm Press Release 454, 220, 69, 76
11/13/2013 3 Fellers   Chocolate Cream Pies   Undeclared almonds 3 Fellers LLC Select to View Firm Press Release Select to View Image of Product Label 454, 69, 76
11/13/2013 VitaliKOR   Dietary Supplement   Unapproved new drug Vitality Research Labs, LLC Select to View Firm Press Release Select to View Image of Product Label 454, 512, 54
11/13/2013 Nature’s Pharmacy and Compounding Center   Sterile products in the form of injectable drug or eye drop   Lack of sterility assurance Nature’s Pharmacy and Compounding Center Select to View Firm Press Release 454, 208
11/12/2013 S&M Enterprise   Fruit of Wolfberry   Undeclared sulfites S&M Enterprise Select to View Firm Press Release 454, 69, 220, 76
11/12/2013 Whole Foods Market   Artichoke Wheatberry Salad and Southwest SooFoo Salad   Escherichia coli O157:H7 bacteria Whole Foods Market Select to View Firm Press Release 454, 69, 220
11/11/2013 HyVee   Chocolate Caramel Clusters and Chocolate Covered Caramels   Undeclared peanut Palmer Candy Company Select to View Firm Press Release Select to View Image of Product Label 454, 69, 76
11/10/2013 Athertone Foods   Ready to eat salads and wraps   Escherichia coli O157:H7 bacteria Athertone Foods, Inc. Select to View Firm Press Release 454, 69, 220
11/09/2013 OxyElite Pro   OxyElite Pro dietary supplement products   Products are associated with serious liver damage or acute liver failure USPlabs LLC Select to View Firm Press Release Select to View Image of Product Label 454, 69, 220

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