FDA Alerts
FDA Warns of Rare but Serious Skin Reactions With the Pain Reliever/Fever Reducer Acetaminophen
The US Food and Drug Administration (FDA) is informing the public that acetaminophen has been associated with a risk of rare but serious skin reactions.
Beacon Hill Pharmacy d/b/a Rxtra Solutions Issues Voluntary Nationwide Recall of Certain Sterile Products
Southfield, MI, Beacon Hill Medical Pharmacy d/b/a/ Rxtra Solutions (Beacon Hill) is voluntarily recalling all lots of certain sterile products to the user level.
Purity First Health Products, Inc. Issues Nationwide Recall of Specific Lots of Healthy Life Chemistry B-50, Multi-Mineral and Vitamin C Products
East Northport, New York, Purity First Health Products, Inc. is voluntarily recalling two lots of Healthy Life Chemistry B-50 (100 capsules), one lot of Healthy Life Chemistry Multi-Mineral (200 capsules) and all lot numbers for Healthy Life Chemistry Vitamin C (200 capsules) to the consumer/user level.
Voluntary Recall of Specified Lots of Nova Max Glucose Test Strips
Nova Diabetes Care today announced it is initiating a voluntary recall of 21 lots of the Nova Max Glucose Test Strips distributed both in the USA and outside the continental USA. Nova Max® Plus™ glucose meter kits that include test strips from the recalled lots are also included in this voluntary recall.
FDA Approves Label Changes for Antimalarial Drug Mefloquine Hydrochloride
The US Food and Drug Administration (FDA) is advising the public about strengthened and updated warnings regarding neurologic and psychiatric side effects associated with the antimalarial drug mefloquine hydrochloride.
FDA Limits Usage of Nizoral (Ketoconazole) Oral Tablets
The US Food and Drug Administration (FDA) is taking several actions related to Nizoral (ketoconazole) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems and advising that it can lead to harmful drug interactions with other medications.
FDA Permits Marketing of First US Test Labeled for Simultaneous Detection of Tuberculosis Bacteria and Resistance to the Antibiotic Rifampin
The US Food and Drug Administration today allowed marketing of the Xpert MTB/RIF Assay, the first FDA-reviewed test that can simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain genetic markers that makes them resistant to rifampin, an important antibiotic for the treatment of TB.
FDA Alerts Companies to Stop Illegal Sale of Treatments for Diabetes
The US Food and Drug Administration is taking action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications.
FDA Permits Marketing Test to Help Assess Children and Teens for ADHD
The US Food and Drug Administration today allowed marketing of the first medical device based on brain function to help assess attention deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old.
FDA Approves New Treatment for a Type of Late-Stage Lung Cancer
The US Food and Drug Administration today approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.