The U.S. Food and Drug Administration today allowed marketing of a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound. The combination of laser light pulses and a custom-fit device component that comes in direct contact with the eardrum is designed to use the patient’s own eardrum as a speaker and enables amplification over a wider range of frequencies for some hearing impaired persons. The EarLens Contact Hearing Device (CHD) is indicated for use by adults with mild to severe sensorineural hearing impairment.
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Press Release For Voluntary Recall of Kermit, Inc. Products
Kermit, Inc. of DeLand, Florida issuing a voluntary recall of the following products because of undeclared allegens on the label. Undeclared soy, an ingredient in Worcestershire Sauce, is used to make the following:
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Federal judge enters permanent injunction against Florida dietary supplements maker, Sunset Natural Products Inc.
U.S. Magistrate Judge Edwin G. Torres for the U.S. District Court for the Southern District of Florida entered a consent decree of permanent injunction on Sept. 25, 2015, against Sunset Natural Products Inc. and its two owners, Teresa Martinez (a.k.a. Teresa Martinez-Arroyo) and Elsy Cruz, for manufacturing and distributing adulterated dietary supplements at its facility located in Miami, Florida.
OC RAW DOG Voluntarily Recalls Limited Number of Raw Frozen Dog Food Due to Potential Salmonella Health Risk
OC Raw Dog of Rancho Santa Margarita, CA is voluntarily recalling 640 lbs. of Chicken, Fish & Produce Raw Frozen Canine Formulation. This is being done in an abundance of caution, as the product has the potential to be contaminated with Salmonella.
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TF Supplements Issues Voluntary Nationwide Recall of Dietary Supplements with Undeclared Active Pharmaceutical Ingredients
TF Supplements of Houston, TX, is voluntarily recalling the following product to the consumer level: RHINO 7 packaged in a bottle containing six (6) capsules WITH LOT# K824B719-P and in a single (1) count capsule hang card with LOT# SU-5102617*RP at the consumer level. Lot numbers are on the back top right of the (1) count and on the side of the (6) count bottle. FDA analysis found these products to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase PDE-5 inhibitor which is a class of drugs used to treat male erectile dysfunction, making these products unapproved new drugs. Dapoxetine is an active ingredient not approved by the U.S. Food and Drug Administration (FDA).
Truco Enterprises Recalls 18oz Cafe Style Tortilla Chips Due To The Possible Presence Of Undeclared Milk Allergen
Truco Enterprises is recalling select packages of 18 oz. On The Border Café Style Tortilla Chips after notification from a supplier that select product may have been exposed to a milk-containing ingredient. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
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Western Milling LLC Voluntarily Recalls Western Blend Horse Feed, Lot 5251 due to potential Monensin contamination.
Western Milling announced today that it has voluntarily recalled 50 lb bags of Western Blend horse feed, LOT 5251, manufactured on September 8, 2015. This voluntary recall was initiated by Western Milling after it learned that an ingredient in the feed in question may contain monensin, an ionophore.
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FDA approves two new drug treatments for diabetes mellitus
The U.S. Food and Drug Administration today approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus.
Mr. Goodcents Franchise Systems, Inc. Voluntarily Issues Allergy Alert On Undeclared Peanuts In A Chocolate Chip Cookie
Mr. Goodcents Franchise Systems, Inc. of De Soto, KS is voluntarily recalling Chocolate Chip Cookies because they may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.
Mr. Goodcents Franchise Systems, Inc. Voluntarily Issues Allergy Alert On Undeclared Peanuts In A Chocolate Chip Cookie
Mr. Goodcents Franchise Systems, Inc. of De Soto, KS is voluntarily recalling Chocolate Chip Cookies because they may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.