Statement from FDA Commissioner Scott Gottlieb, M.D. and FDA Deputy Commissioner Frank Yiannas on new findings and updated consumer recommendations related to the romaine lettuce E. coli O157:H7 outbreak investigation
Statement from FDA Commissioner Scott Gottlieb, M.D. and Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D., on efforts to modernize generic drug labels while maintaining the efficiency of generic development
FDA announces withdrawal of the proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
Del Monte Foods Announces Limited Recall of Canned Fiesta Corn Seasoned with Red & Green Peppers Due to Under Processing
Del Monte Foods Inc. announced a recall of 64,242 cases of FIESTA CORN Seasoned with Red & Green Peppers due to under-processing. These deviations were part of the commercial sterilization process and could result in contamination by spoilage organisms or pathogens, which could lead to life-threatening illness if consumed. It is important to note that there have been no reports of illness associated with these products to date. No other production codes or products are affected by this recall.
Kimberly-Clark Announces Voluntary Recall of U by Kotex® Sleek® Tampons, Regular Absorbency,Throughout U.S. and Canada
Kimberly-Clark announced a voluntary product recall of its U by Kotex® Sleek® Tampons, Regular Absorbency, sold throughout the United States and Canada for a quality-related defect that could impact the performance of this product.
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice
FDA releases guidance with recommendations for drug manufacturers regarding good manufacturing practices and data integrity
Moonstruck Chocolate Co. Issues Allergy Alert On Undeclared Hazelnuts In 4 Oz. Sea Salt Caramels Tumbled In Milk Chocolate
Moonstruck Chocolate Company of Portland, Oregon is recalling 600/4 oz. bags of Sea Salt Caramels Tumbled In Milk Chocolate, because it may contain undeclared hazelnuts. People who have an allergy or severe sensitivity to hazelnuts run the risk of a serious or life-threatening allergic reaction if they consume this product.
FDA warns API manufacturer involved in valsartan recall, provides information for patients taking these medications
FDA update on the ongoing investigation into angiotensin II receptor blocker impurities, recalls and current findings.
Inspired Organics Issues Voluntary Recall of Organic Sunflower Butter Due to Potential Health Risk
Inspired Organics, LLC has issued a voluntary recall of Organic Sunflower Butter due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework
FDA announces new actions advancing the agency’s biosimilars policy framework
Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data
FDA provides updates to postmarketing studies that agency ordered three manufacturers of duodenoscopes to conduct to assess bacterial contamination of devices.