The U.S. Food and Drug Administration today issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.
Bee International Expands Allergy Alert on Undeclared Egg in "Sweet Spots"
Bee International, Inc. of Chula Vista, CA is recalling its 2oz. packages of candy “Sweet Spots” because they may contain undeclared egg protein. People who have allergies to egg may run the risk of serious or life-threatening allergic reaction if they consume this product.
Megabusiness LLC Issues Alert on Undeclared Sulfites in Del Campo Papa Seca / DRY Potato 24×14 oz.
Megabusiness LLC of Danbury, CT is recalling Del Campo Papa seca / DRY POTATO 24×14 oz. because they contain undeclared sulfites. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products.
Blooming Import Inc. Issues an Alert on Undeclared Sulfites in Farmer Brand Dried Lily Flowers
Blooming Import Inc at 45 Bowne Street, Brooklyn, NY 11231 is recalling Farmer Brand Dried Lily Flowers because they contain undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.
Stone Independent Research, Inc. Issues Allergy Alert on Undeclared Milk in EnhanceRx Dietary Supplement
Stone Independent Research, Inc. of Syracuse, NY is recalling 15,657 units of EnhanceRx, a dietary supplement, because it contains undeclared milk (whey protein). People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
Stone Independent Research, Inc. Issues Allergy Alert on Undeclared Milk in One Lot of Zanocap Capsules
Stone Independent Research, Inc. of Syracuse, NY is recalling 1,040 units of Zanocap Scientific Weight Loss 500 mg capsules because it contains undeclared milk (whey protein). People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume the affected product.
FDA allows marketing of first device to relieve migraine headache pain
The U.S. Food and Drug Administration today allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS), the first device to relieve pain caused by migraine headaches that are preceded by an aura: a visual, sensory or motor disturbance immediately preceding the onset of a migraine attack.
Alexion Provides Update on Previously Communicated November 2013 Voluntary Nationwide Recall of Two Lots of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion
December 13, 2013 – Cheshire, Conn., – Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today is providing further information regarding a previously communicated voluntary recall of two lots of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion. As stated on Nov. 12, 2013, the two lots were found to contain visible particles.
Bee International Issues Allergy Alert on Undeclared Egg in "Sweet Spots"
ee International, Inc. of Chula Vista, CA is recalling its 2oz. packages of candy “Sweet Spots” because they may contain undeclared egg protein. People who have allergies to egg may run the risk of serious or life-threatening allergic reaction if they consume this product.
Pin Hsiao & Associates, LLC. Issues Allergy Alert on Undeclared Walnuts in Gluten Free Blueberry Mini Muffins – 12 pk.
Pin Hsiao & Associates, LLC of Bellevue, Washington is recalling the Gluten Free Blueberry Mini Muffins – 12pk, because it may contain undeclared walnuts. People who have an allergy or severe sensitivity to walnuts run the risk of serious or life-threatening allergic reaction if they consume this product.