Today, the U.S. Food and Drug Administration announced it has issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several were found to contain salmonella. The agency took this action after the company failed to cooperate with the FDA’s request to conduct a voluntary recall. This is the first time the agency has issued a mandatory recall order to protect Americans from contaminated food products.
Category Archives: Drug Safety Information Podcasts
New York raw milk cheese company ordered to stop sales for food safety violations
FDA announces an enforcement action taken against Vulto Creamery of New York. The company cannot sell ready-to-eat raw cheese product until it complies with the consent decree. Vulto was linked to an outbreak last year.
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to enhance the patient perspective and experience in drug development and review
FDA issues update to Benefit-Risk Assessment plan as part of efforts to enhance the patient perspective and experience in drug development and review
FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse
FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse
Federal judge approves consent decree with New York dietary supplement manufacturer Riddhi USA
A New York dietary supplement manufacturer has been ordered by a federal court to stop selling its products until the company comes into compliance with the FDA’s dietary supplement manufacturing regulations.
Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs
Federal judge approves consent decree with Florida company that sold unapproved new drugs and misbranded drugs
FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices
The authorization classifies integrated continuous glucose monitoring devices in class II and subjects them to certain criteria called special controls
Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities
Statement from FDA Commissioner Scott Gottlieb, M.D., on a key step in advancing FDA’s oversight of drug compounding and implementing new laws governing outsourcing facilities
Statement from FDA’s Donald St. Pierre on findings from ongoing investigation into lead testing issues
FDA on findings from ongoing investigation into lead testing issues; studies find chemical interaction during test processing may contribute to skewing results
FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy
FDA approves Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy