The U.S. Food and Drug Administration today approved Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Using Kybella for the treatment of fat outside of the submental area is not approved and is not recommended.
Category Archives: Food & Drug Recalls
Hy-Vee Recalls Summer Fresh Pasta Salad
On April 27, 2015, Hy-Vee, Inc. issued a recall for Hy-Vee Summer Fresh Pasta Salad that is sold in its stores’ kitchen department cold cases and salad bars. The pasta was recalled after Hy-Vee was notified the frozen vegetables used to make the ready-to-eat pasta were potentially contaminated with Listeria monocytogenes.
FDA approves first generic Abilify to treat mental illnesses
The U.S. Food and Drug Administration today approved the first generic versions of Abilify (aripiprazole). Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.
Waymouth Farms, Inc. Recalls Raw Pine Nuts Because of Possible Health Risk
Waymouth Farms, Inc. of New Hope, MN is recalling RAW PINE NUTS in various sizes, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.
FDA enters consent decree with Medtronic, Inc.
The U.S. Food and Drug Administration announced today the filing of a consent decree against Medtronic, Inc., and two of the company’s officers—S. Omar Ishrak and Thomas M. Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. These violations occurred at the company’s Neuromodulation facilities in Columbia Heights, Minnesota, where the devices are manufactured.
TFH Publications, Inc./Nylabone Products Recalls Puppy Starter Kit Due To Possible Salmonella Health Risk
TFH Publications, Inc./Nylabone Products, of Neptune, NJ is recalling one lot of its 1.69 oz. package of the Puppy Starter Kit dog chews, because they have the potential to be contaminated with Salmonella. Salmonella can affect animals ingesting the product and there is risk to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Greystone Foods, LLC voluntarily recalls Today’s Harvest Field Peas with Snaps, Silver Queen Corn, and Broccoli Florets due to possible health risk.
Greystone Foods, LLC voluntarily recalls Today’s Harvest Field Peas with Snaps, Silver Queen Corn, and Broccoli Florets with the sell by date 04/21/16 shipped to Publix Supermarkets warehouse in Lakeland, FL warehouse due to possible health risk.
Mylan Initiates Voluntary Nationwide Recall of Select Lots of Injectable Products Due to the Presence of Particulate Matter
Mylan N.V. (Nasdaq: MYL) today announced that its U.S.-based Mylan Institutional business is conducting a voluntary nationwide recall to the hospital/user level of select lots of the following injectable products due to the presence of visible foreign particulate matter observed during testing of retention samples.
Sweet Sam’s Baking Company Issues Allergy Alert on Undeclared Milk in Starbucks Black & White Mini Cookies
Sweet Sam’s Baking Company of Bronx, NY is recalling all lots of Starbucks Black & White Mini Cookies sold in Starbucks Company operated stores on or before Thursday, April 23rd, 2015, because they contain milk, an allergen that is not declared on the packaging. People who have an allergy to milk run the risk of experiencing a serious or life-threatening reaction if they consume the product.
Jeni’s Splendid Ice Creams Recalls All Products Because of Possible Health Risks
Jeni’s Splendid Ice Creams has initiated a voluntary recall of all ice creams, frozen yogurts, sorbets, and ice cream sandwiches for all flavors and containers because of the possible presence of Listeria monocytogenes. The company is ceasing all sales and closing all scoop shops until all products are ensured to be 100% safe.
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