FDA statement on scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse
Kanan Enterprises Conducts Voluntary Recall of Southern Grove Unsalted Almond Due to Undeclared Wheat and Soy
Kanan Enterprises announces the voluntary recall of Southern Grove Unsalted Almond 14 oz., Best By SEP 25 2018 KN due to the presence of wheat and soy that are not listed as ingredients. People who have an allergy to wheat or soy run the risk of a serious or life-threatening allergic reaction if they consume these products. No adverse reactions have been reported associated with this recall.
Statement from Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health on the recent National Toxicology Program draft report on radiofrequency energy exposure
One part of the Food and Drug Administration’s mission is to ensure the safety of electronic products that emit radiation, like televisions and cell phones. These types of products are part of Americans’ daily life and we take our duty to protect consumers with the utmost gravity. With cell phones, we have relied extensively on a myriad scientific evidence developed over many years to help inform our regulatory thinking. Although the Federal Communications Commission (FCC) sets the standard for radiofrequency energy exposure limits from cell phones, the FCC relies on the FDA and other health agencies for scientific expertise and input regarding those standards.
JFC International Inc. Issues Allergy Alert on Undeclared Crustacean Shellfish (Shrimp, Crab) in Daisho Kimchi Hot Pot Soup Base
JFC International Inc. of Los Angeles, CA is voluntarily recalling a Kimchi Hot Pot Soup Base because it was found to contain undeclared Crustacean Shellfish (Shrimp, Crab). Individuals who have allergies to crustacean shellfish (shrimp, crab) runs the risk of a serious life-threatening allergic reaction if they consume the product. One incident has been reported to date in connection with this issue.
Kareway Products, Inc Issues Voluntary Nationwide Recall of Gericare Eye Wash due to Complaints Received on Potential Product Contamination which Compromises Sterility
Compton, California, Kareway Products, Inc is voluntarily recalling 60,000 lots of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility.
Statement from FDA Commissioner Scott Gottlieb, M.D., on ongoing efforts to mitigate impact of saline shortages during this flu season
FDA provides update on ongoing efforts to mitigate impact of saline shortages and monitor other critical products during flu season
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help prevent new addiction, curb abuse and overdose related to opioid products
FDA, USDA announce formal agreement to bolster coordination and collaboration
FDA Commissioner Dr. Scott Gottlieb and USDA Secretary Perdue launched an effort today to increase collaboration, efficiency and effectiveness, and provide clarity to food producers.
Primus Announces a Voluntary Nationwide Recall of All Lots Within Expiry of Prescription Medical Food Limbrel® Due to Rare But Serious and Reversible Adverse Events While Seeking FDA’s Cooperation to Restore Access for Patients with Medical Necessity
Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA’s request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel.
Panera Bread Preemptively Recalls All 2 oz. and 8 oz. Cream Cheese Products
While there have been no reported illnesses, out of an abundance of caution, Panera Bread is conducting a nationwide preemptive, voluntary recall of all 2 oz. and 8 oz. cream cheese products sold in its U.S. bakery-cafes. This recall was initiated after samples of one variety of 2 oz. cream cheese from a single production day showed a positive result for the presence of Listeria monocytogenes. Tests on cream cheese samples manufactured both before and after the production run in question have all come back negative.