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U.S. Department of Health and Human Services

Safety

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2013 Recalls, Market Withdrawals & Safety Alerts

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Date Brand Name Product Description Reason/Problem Company Details/Photo
04/24/2013 Cook Medical   Zilver® PTX® Drug Eluting Peripheral Stent   Delivery system tip separation Cook Medical Select to View Firm Press Release Select to View Image of Product Label
04/23/2013 7th Heaven Bakeries   Oatmeal Raisin Cookies   Undeclared Egg, Soy, and Milk 7th Heaven Bakeries Select to View Firm Press Release Select to View Image of Product Label
04/23/2013 ebA   Multivitamin Supplement   Undeclared milk Saratoga Therapeutics, LLC Select to View Firm Press Release Select to View Image of Product Label
04/22/2013 Snap!, Cleo's, Jokerz and more   Vegan Candy Bars   Undeclared Milk Go Max Go Foods, LLC Select to View Firm Press Release Select to View Image of Product Label
04/22/2013 Nora Apothecary & Alternative Therapies   All Sterile Compounded Drug Products within Expiration   Lack of Sterility Assurance Nora Apothecary & Alternative Therapies Select to View Firm Press Release
04/22/2013 Giraffe   Giraffe Incubator with a Servo Control Oxygen System and Giraffe OmniBed   After Powered On the oxygen set point or radiant heater set point may be overwritten. GE Healthcare Select to View Firm Press Release
04/19/2013 California Natural, EVO, Healthwise, Innova, Karma.   Pet Food   Salmonella Natura Pet Products Select to View Firm Press Release
04/18/2013 Newport   Battery Pack   Ventilators are alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery. Covidien Select to View Firm Press Release
04/18/2013 Vitae   Bird food   Salmonella Merit Bird Company, LLC Select to View Firm Press Release
04/17/2013 Latis   Herring and Salmon   Listeria monocytogenes Prime Food USA Select to View Firm Press Release Select to View Image of Product Label
04/17/2013 Balanced Solutions Compounding Pharmacy   Sterile drug products   Lack of sterility assurance. Balanced Solutions Compounding Pharmacy, LLC Select to View Firm Press Release
04/16/2013 Wegmans   Roasted Red Pepper Dip   Undeclared Eggs and Milk Wegmans Food Markets Select to View Firm Press Release Select to View Image of Product Label
04/15/2013 NuVision Pharmacy   Lyophilized compounds HcG 5000IU-5ml and Sermorelin/GHRH6-5ml   Lack of sterility assurance NuVision Pharmacy Select to View Firm Press Release Select to View Image of Product Label
04/15/2013 ApothéCure   Sterile drug products   Lack of sterility assurance ApothéCure Inc. Select to View Firm Press Release
04/15/2013 O Organics   Enchiladas   Undeclared milk Cedarlane Natural Foods, Inc. Select to View Firm Press Release Select to View Image of Product Label
04/15/2013 InsuLinx   Blood Glucose Meter   lnsuLinx Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. Abbott Select to View Firm Press Release
04/12/2013 Chappaqua Crunch   Simply Granola with Flax and Fruit (Gluten Free)   Undeclared Almonds Wild Blue Yonder Foods Select to View Firm Press Release Select to View Image of Product Label
04/12/2013 Winn Dixie   Apple Juice   May contain elevated levels of patulin. Winn Dixie Select to View Firm Press Release Select to View Image of Product Label
04/10/2013 Affirm XL   Dietary supplement   Contain an analogue of sildenafil Affirm XL Select to View Firm Press Release Select to View Image of Product Label
04/10/2013 Stryker Corporation   ShapeMatch Cutting Guides   Due to the potential that ShapeMatch Cutting Guides may not have been manufactured in accordance with surgeon preoperative planning parameters or may have been manufactured outside of the planning ranges specified in the 510(k) clearance Stryker Corporation Select to View Firm Press Release
04/10/2013 Showmaster®   Lamb feed   Contains incorrect sodium molybdate levels Cargill Select to View Firm Press Release
04/05/2013 Green Valley Drugs   Sterile, compounded products   Lack of sterility assurance and concerns associated with the quality control processes Green Valley Drugs Select to View Firm Press Release
04/04/2013 Little Mermaid Smoke House   Smoked Herring and Pickled Herring fish   Products were found to be uneviscerated, and have the potential to be contaminated with Clostridium botulinum Little Mermaid Smoke House Select to View Firm Press Release Select to View Image of Product Label
04/04/2013 Farm Rich, Market Day, Schwan's   Mozzarella bites, quesadillas, pizza slices and more   Escherichia coli O121 Rich Products Corporation Select to View Firm Press Release
04/04/2013 Centerville Pie   Clam Pies   Undeclared fish (anchovies) Centerville Pie Company Select to View Firm Press Release Select to View Image of Product Label
04/03/2013 Bravo!   Chicken Balance, Chicken Blend and Beef Blend Burgers - Raw Frozen Food Diet for Dogs and Cats   Potential to be contaminated with Salmonella Bravo! Select to View Firm Press Release
04/01/2013 ROCK-IT-MAN   Male sexual enhancement capsules   Product contains hydroxythiohomosildenafil, an analogue of sildenafil Consumer Concepts, Inc. Select to View Firm Press Release Select to View Image of Product Label
03/29/2013 California Natural, Evo, Health Wise, more   Pet food   Salmonella Natura Pet Products Select to View Firm Press Release Select to View Image of Product Label
03/29/2013 Hospira   Sodium Chloride Injection   Brass particulates Hospira, Inc. Select to View Firm Press Release Select to View Image of Product Label
03/28/2013 Heartland Gourmet   Cookie mix, Pizza mix   Undeclared milk Heartland Gourmet, LLC Select to View Firm Press Release Select to View Image of Product Label



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