Podcast FDA medical oncologists discuss the agency’s December 2016 accelerated approval of rucaparib for treatment of patients with deleterious BRCA mutation associated advanced ovarian cancer who have been treated with two or more chemotherapies. Transcript: Sanjeeve Bala: Welcome to the D.I.S.C.O. Today’s Drug Information Soundcast in Clinical Oncology from FDA’s Oncology Center of Excellence will…
American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP 150 mg, 100 Count Unit Dose Blisters Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity
Summary Company Announcement Date: February 27, 2020 FDA Publish Date: February 27, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description NDMA (Nitrosodimethylamine) impurity Company Name: American Health Packaging Brand Name: Brand Name(s) American Health Packaging Product Description: Product Description Ranitidine Tablets, USP 150mg Company Announcement American Health Packaging has voluntarily recalled eleven (11)…
Some Medications and Driving Don’t Mix
If you are taking a medication, is it OK to drive? Most likely, yes. But the Food and Drug Administration (FDA) advises that it’s best to be absolutely sure before you get behind the wheel. While most medications don’t affect driving ability, some prescription and over-the-counter (OTC) medicines can cause reactions that may make it…
FDA D.I.S.C.O.: Intro by Dr. Richard Pazdur
Podcast In our inaugural podcast, Dr. Richard Pazdur, director of the FDA Oncology Center of Excellence, talks with hosts Dr. Sanjeeve Bala and Dr. Abhilasha Nair about this new podcast series. Transcript: Sanjeeve Bala: Welcome to the D.I.S.C.O.—the first Drug Information Soundcast in Clinical Oncology from FDA’s Oncology Center of Excellence. Abhi Nair: Hi, I’m…
King Systems Recalls King Vision Video Laryngoscope Adapter Size ½ Due to a Display of The Reversed Image
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product King Vision Video Laryngoscope Reusable Adapter Size ½, (KVLVA12) Lot Numbers: 010614, 010629, 010657, 010668, 010670, 010722 Serial numbers: LHXXXXXXX10240, LHXXXXXXX10243, LHXXXXXXX10284, LHXXXXXXX10554, LHXXXXXXX10559, LHXXXXXXX10562, LHXXXXXXX10569, LHXXXXXXX10570,…
When to Give Kids Medicine for Coughs and Colds
Español Although most colds in children don’t cause serious complications, they can cause anxiety in parents and caregivers. And colds are among the top reasons children visit a doctor. Both non-prescription (over-the-counter) and prescription medicines are available to treat cough and cold symptoms. But most children will get better on their own and may not…
FDA D.I.S.C.O.: Olaparib for gBRCAm HER2-negative metastatic breast cancer
Podcast Olaparib FDA medical oncologists discuss the January 12, 2018, approval of olaparib, the first PARP inhibitor approved for the treatment of patients with metastatic breast cancer with a germline BRCA mutation. Sanjeeve Bala: Welcome back to the DISCO, the FDA’s Soundcast in Clinical Oncology from the Oncology Center of Excellence. We are in Silver…
Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication
Date Issued: February 27, 2020 The U.S. Food and Drug Administration (FDA) wants to make consumers and health care providers aware that, to date, the FDA has not authorized for market any products using ozone gas or ultraviolet (UV) light to clean, disinfect, or sanitize continuous positive airway pressure (CPAP) devices and accessories (for example: hoses,…
Choice Products USA, LLC Issues an Allergy Alert on Undeclared Milk in Premier Choice 3 lb. Tub Peanut Butter Cookie Dough Ordered Through Online Ordering
Summary Company Announcement Date: February 26, 2020 FDA Publish Date: February 27, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Choice Products USA, LLC Brand Name: Brand Name(s) Premier Choice Product Description: Product Description 3 lb. tub Peanut Butter Cookie Dough Company Announcement Choice Products USA, LLC…
For Women: The FDA Gives Tips to Prevent Heart Disease
A healthy heart needs a healthy diet, which includes eating a variety of fruits or vegetables each day. Español More women die from heart disease than from any other cause: about one in four American women, according to the Centers for Disease Control and Prevention. But you can take action now to reduce your risk….