Regalo Bakery is recalling the following products due to undeclared Eggs, Wheat, Milk, Soy, and Artificial Food Coloring: “Spanish Rolls”, “Manju Blackbeans(Hopia Monggo)”, Manju Onions(Hopia Baboy)”, “Balintawak”, and “Taro Bread”. “Kababayan” contains no egg, but contains wheat, soy, and artificial food colorings. Read The Complete Story!
The U.S. Food and Drug Administration today allowed marketing of two Trevo clot retrieval devices as an initial therapy for strokes due to blood clots (ischemic) to reduce paralysis, speech difficulties and other stroke disabilities. These devices should be used within six hours of symptom onset and only following treatment with a clot-dissolving drug (tissue […]
The U.S. Food and Drug Administration today allowed marketing of two Trevo clot retrieval devices as an initial therapy for strokes due to blood clots (ischemic) to reduce paralysis, speech difficulties and other stroke disabilities. These devices should be used within six hours of symptom onset and only following treatment with a clot-dissolving drug (tissue […]
The U.S. Food and Drug Administration today issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed.
The U.S. Food and Drug Administration today issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed.
Magic Gourmet Trading Inc. of Millbrae, CA is recalling all Koi Palace Mooncake products purchased in August 2016 because these items do not contain proper labeling of ingredients and possible allergens. Mooncake products manufactured by Magic Gourmet contain possible allergens such as wheat, gluten, eggs, milk, peanuts, pine nuts, almonds, walnuts, and/or sesame. Read The […]
FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use
Snyder’s-Lance, Inc. is initiating a voluntary recall of Diamond of California Macadamia Nuts, distributed in retail stores nationwide, due to possible Salmonella contamination. Read The Complete Story!
Snyder’s-Lance, Inc. is initiating a voluntary recall of Diamond of California Macadamia Nuts, distributed in retail stores nationwide, due to possible Salmonella contamination. Read The Complete Story!
The U.S. Food and Drug Administration today approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998.
As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.
As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.
The FDA and representatives from the medical device industry and laboratory community have reached an agreement in principle on proposed recommendations for the fourth reauthorization of a medical device user fee program. Under the new draft agreement, the FDA would be authorized to collect $999.5 million in user fees plus adjustments for inflation over five […]
The U.S. Food and Drug Administration today permitted marketing of two new devices to assess a patient’s cognitive function immediately after a suspected brain injury or concussion. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to assess cognitive function following a […]
The U.S. Food and Drug Administration today approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved only in patients at high or greater risk for death […]
Ton Shen Health of Chicago, IL, is recalling its “DHZC-2” Tablets because they have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children. Lead poisoning can happen if a person is exposed to high levels of lead over […]
The U.S. Food and Drug Administration today issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers.
The U.S. Food and Drug Administration today issued draft updated recommendations to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market, including a separate guidance applicable to software devices.
The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 100 cases of products labeled as containing kratom. The products are distributed by Nature Therapeutics LLC, which does business as Kratom Therapy and is located in Grover Beach, California. The seized products are marketed under the brand name Kratom […]