The U.S. Food and Drug Administration today approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.
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FDA approves wearable defibrillator for children at risk for sudden cardiac arrest
The U.S. Food and Drug Administration today approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.
FDA approves Basaglar, the first “follow-on” insulin glargine product to treat diabetes
The U.S. Food and Drug Administration today approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Trader Joe’s Issues Voluntary Recall of Triple Ginger Brew
Trader Joe’s of Monrovia, CA is issuing a voluntary recall of all codes purchased from 11/9/15 through 12/14/15 of Triple Ginger Brew (SKU 51857) due to reports of unopened bottles potentially bursting. Although the ginger brew does not pose a health risk if consumed, all product has been removed from store shelves and destroyed. No injuries or illnesses have been reported to date.
Stella & Chewy’s Voluntarily Recalls Frozen Dinner Morsel Products Due to Possible Health Risk
Stella & Chewy’s is voluntarily recalling four of its products sold in the U.S. and Canada due to concerns of a possible presence of Listeria monocytogenes. The recall affects a total of 990 cases (964 cases in the U.S and 26 cases in Canada).
FDA approves Bridion to reverse effects of neuromuscular blocking drugs used during surgery
The U.S. Food and Drug Administration today approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults.
FDA takes action against Vermont dairy farm for illegally administering drugs to cattle
Today, the U.S. Department of Justice entered a consent decree of permanent injunction in the District of Vermont against the Correia Family Limited Partnership, doing business as Wynsum Holsteins, a dairy farm located in West Addison, Vermont, and its partners, Anthony Correia, Barbara Correia and Stephen Correia. The decree accompanies a complaint filed at the request of the U.S. Food and Drug Administration.
Sun Noodle- New Jersey- Issues Allergy Alert on Undeclared Egg in Tonkotsu Ramen
Sun Noodle of Teterboro, NJ is voluntarily recalling its Tonkotsu Ramen because it may contain undeclared egg. Individuals who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening allergic reaction if they consume this product.
Reesna Inc., Issues a Voluntary Nationwide Recall of Fuel Up Plus and Fuel Up High Octane due to the Presence of Undeclared Hydroxythiohomosildenafil
Reesna Inc., Canoga Park, CA, is voluntarily recalling all lots of Fuel Up Plus and Fuel Up High Octane particularly distributed in August 2015 due to containing undeclared hydroxythiohomosildenafil, an analogue of sildenafil. Sildenafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making Fuel Up an unapproved drug. The problem was found after FDA sampled the product and the results were positive for undeclared hydroxythiohomosildenafil.
FDA approves new oral therapy to treat ALK-positive lung cancer
The U.S. Food and Drug Administration today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib).