The U.S. Food and Drug Administration today approved the first implantable device for people 18 and older with severe or profound sensorineural hearing loss of high-frequency sounds in both ears, but who can still hear low-frequency sounds with or without a hearing aid. The Nucleus Hybrid L24 Cochlear Implant System may help those with this specific kind of hearing loss who do not benefit from conventional hearing aids.
Helados La Tapatia, Inc. Retira Productos Debido a un Posible Riesgo de Salud
Helados La Tapatia, Inc. de Fresno, California, esta retirando voluntariamente todos los productos de helados, helados de agua, barras de fruta/los vasos de frutas y bolis debido a un posible riesgo para la salud de Listeria Monocytogenes. Helados La Tapatia, Inc., esta coordinando estrechamente con los funcionarios reguladores. Listeria Monocytogenes es un organismo que puede causar infecciones serias y a veces fatales en ninos, ninos pequenos, personas debiles o ancianas, y otros con sistemas inmunologicos debilitados.
Terra-Medica Issues Voluntary Nationwide Recall of Specified Lots of Pleo Homeopathic Drug Products Due to the Potential for Undeclared Penicillin
Terra-Medica, Inc. is voluntarily recalling 56 lots of Pleo-FORT, Pleo-QUENT, Pleo-NOT, Pleo-STOLO, Pleo-NOTA-QUENT, and Pleo-EX homeopathic drug products in liquid, tablet, capsule, ointment, and suppository forms to the consumer level. FDA has determined that these products have the potential to contain penicillin or derivatives of penicillin, which may be produced during the fermentation process.
FDA approves Impavido to treat tropical disease leishmaniasis
The U.S. Food and Drug Administration today approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis.
Helados La Tapatia, Inc. Recalls Products Because of Possible Health Risk
Helados La Tapatia, Inc., of Fresno, California, is voluntarily recalling all ice cream products, popsicles, fruit bars/cups and bolis due to a possible health risk from Listeria monocytogenes. Helados La Tapatia, Inc., is coordinating closely with regulatory officials.
Harry’s Farmers Market Recalls Amberjack From One Store in Marietta, GA. Due to Possible Health Risk
Harry’s Farmers Market is recalling the following Wild Gulf Amberjack due to five reported customer illnesses. This product was sold through March 15, 2014 in the fresh seafood case only at the Harry’s Farmers Market 70 Powers Ferry Road SE in Marietta, GA 30067.
Playtex Announces the Voluntary Nationwide Recall of Certain AC/DC Power Adapters Used With the Playtex® Nurser Deluxe Double Electric Breast Pump Due to Potential for Electric Shock
Shelton, CT. – March 18, 2014 – Energizer Personal Care – Playtex Manufacturing, Inc. announced today it is initiating a voluntary nationwide recall of certain AC/DC power adapters that are used with the Playtex® Nurser Deluxe Double Electric Breast Pump. Consumer safety is a primary objective of Playtex and we are taking this action out of an abundance of caution.
Hospira Announces Voluntary Nationwide Recall of Hemoset Blood Set
Hospira, Inc. (NYSE: HSP), announced today a nationwide recall of two lots of Hemoset Dual Channel Plum Sets (list number 11241-03, lot numbers 28005-5H and 34100-5H). Hospira identified that an incorrect set component was supplied and used during the manufacturing process of the impacted product lots.
Some lots of Simply Lite brand dark chocolate recalled
The U.S. Food and Drug Administration warns consumers that it has tested and found milk protein in 3-ounce bars of Simply Lite brand 50% Cacao Low Carb Sugar Free Dark Chocolate bearing the lot codes “Best By: 01 18 2015A” or “Best By: 01 19 2015A.” Milk is a major food allergen, but it is not declared as an ingredient on the label.
Simply Natural Foods, Llc Issues Allergy Alert For high Levels Of Milk Protein In Simply Lite Dark Chocolate Bars
Simply Natural Foods, LLC of Commack, N.Y., is voluntarily recalling its 85g (3oz) Simply Lite Dark Chocolate Bar, because FDA testing indicated that bars from certain lots contained high levels of milk protein, while the label of the product stated that it may contain traces of milk. People who have an allergy or severe sensitivity to milk protein may risk serious or life-threatening allergic reaction if they consume this product.