Today, Somersault Snack Co., LLC, in cooperation with the U.S. Food and Drug Administration (FDA) is voluntarily recalling a limited number of packages of 1 ounce Somersault Pacific Sea Salt products which were distributed to Target Stores in 6-Count Multi-Packs, and which were inadvertently mispackaged—limited quantities of Somersault Santa Fe Salsa flavored product were inadvertently commingled with Somersault Pacific Sea Salt flavored product in packages labeled as Somersault Pacific Sea Salt 1oz. The inadvertent commingling of these two products introduced another allergen (milk) to the Somersault Pacific Sea Salt 1oz. packages, and that allergen (milk) is not listed on the packaging as either an ingredient or an allergen.
HEALTH Advises Consumers Not to Eat Certain Olives
The Rhode Island Department of Health (HEALTH) advises consumers not to eat Mediterranean Olives: Calcidica Sweet (Brand: Bel Frantoio) sold at any Ocean State Job Lot (OSJL) stores. OSJL is voluntarily recalling the product after HEALTH staff discovered that these products were not handled appropriately to prevent production of the toxin that causes botulism.
Fresenius Kabi USA Issues Voluntary Nationwide Recall of Benztropine Mesylate Injection, USP 2 mg/2 mL (1 mg/mL), in 2 mL Single Dose Vials
LAKE ZURICH, Ill. – Fresenius Kabi USA is voluntarily recalling four lots of Benztropine Mesylate Injection, USP, 2 mg/2mL (1mg/mL) in 2 mL single dose vials due to the potential presence of glass particles (glass delamination) in the vials. This recall is being conducted to the user level.
Talenti Gelato Issues Allergy Alert For Undeclared Allergen (pecans) In Toasted Almond Gelato
Talenti® Gelato & Sorbetto is voluntarily initiating a product recall of Talenti Gelato Toasted Almond Gelato with the UPC # 1 86852 00039 6 with a BEST BY DATE of 11/15/2014 M1 as a precautionary measure. The recall was initiated after it was discovered that the product containing pecans was distributed in packaging that did not reveal the presence of pecans.
FDA to detain pomegranate seeds offered for import from Goknur of Turkey
The U.S. Food and Drug Administration will detain shipments of pomegranate seeds from Goknur Gida Maddeleri Ithalat Ihracat Tic (Goknur Foodstuffs Import Export Trading) of Turkey when they are offered for import into the United States.
UPDATED RELEASE #3 UPC Code Clarification Townsend Farms, Inc. Expands Voluntary Limited Lot Recall of Frozen Organic Antioxidant Blend, 3 lb. Bag
Townsend Farms, Inc. of Fairview, Oregon, out of an abundance of caution and in cooperation with the FDA is expanding its voluntary recall efforts and is now recalling Townsend Farms Organic Antioxidant Blend, 3 lb. bag with UPC 0 78414 40444 8. The recall codes are located on the back of the package with the words “BEST BY” followed by the code T122114 sequentially through T053115, followed by a letter.
Harmony Chai Voluntary Recall of Concentrated Black Spiced Chai and Decaffeinated Rooibos Chai
Harmony Chai of Eastsound, WA is voluntarily recalling its Concentrated Black Spiced Chai and Decaffeinated Rooibos Chai because it may not be properly processed. Although Harmony Chai has received no complaints of illness related to the consumption of the recalled product, there is a potential hazard that can occur when tea beverages are inadequately processed.
FDA approves the first non-hormonal treatment for hot flashes associated with menopause
The U.S. Food and Drug Administration today approved Brisdelle (paroxetine) to treat moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle, which contains the selective serotonin reuptake inhibitor paroxetine mesylate, is currently the only non-hormonal treatment for hot flashes approved by the FDA.
Federal judge enters consent decree with Med Prep Consulting
A federal judge from the U.S. District Court for New Jersey has entered a consent decree of permanent injunction against Med Prep Consulting, Inc., a pharmacy licensed by the state of New Jersey, and Gerald R. Tighe, the company’s president and owner. The U.S. Department of Justice sought the consent decree on behalf of the U.S. Food and Drug Administration.
Medtronic Issues Medical Device Notifications Regarding The Synchromed Implantable Infusion System
June 26, 2013 – MINNEAPOLIS – In June 2013, Medtronic, Inc. (NYSE: MDT) initiated four medical device notifications to customers worldwide about the SynchroMed Implantable Infusion System. These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System.